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1.
J Fr Ophtalmol ; 46(6): 596-604, 2023 Jun.
Article in French | MEDLINE | ID: covidwho-20232688

ABSTRACT

PURPOSE: To assess the impact of the measures taken during the lockdown period from March 17 to May 11, 2020 on the management of patients with exudative age related macular degeneration treated by intravitreal anti-VEGF injections at the University Hospital of Tours. METHODS: In this retrospective study, patients were included after analysis of the computerized medical records of patients with age related macular degeneration. Those who were treated for exudative age related macular degeneration who received at least 1 intravitreal injection in the 12 months prior and at least one consultation in the 6 months prior to the lockdown period, were included. The initial and final mean visual acuity were compared with a 5 letter non-inferiority margin. A subgroup analysis was performed according to outcomes. The visual acuities immediately after this period were also recorded. RESULTS: In all, 595 eyes of 493 patients were included. The mean initial visual acuity was 59.6 letters, vs. 58.5 for the final visual acuity, i.e. a difference of -1.13 letters with a lower limit of the confidence interval of less than 5. The visual acuity on release from lockdown was comparable to the other 2 measurements. Initial visual acuity and the number of missed treatments were the main factors associated with functional loss. CONCLUSION: Patients' visual acuity during the lockdown period was able to be maintained despite the restrictive measures and limitation of care access in France. The most common cause of substantial visual decline was missed intravitreal injections.


Subject(s)
COVID-19 , Macular Degeneration , Wet Macular Degeneration , Humans , Infant , Angiogenesis Inhibitors/therapeutic use , Ranibizumab , Follow-Up Studies , Retrospective Studies , COVID-19/epidemiology , COVID-19/prevention & control , Communicable Disease Control , Macular Degeneration/drug therapy , Macular Degeneration/epidemiology , Intravitreal Injections , Treatment Outcome , Wet Macular Degeneration/drug therapy , Wet Macular Degeneration/epidemiology
2.
BMC Ophthalmol ; 23(1): 156, 2023 Apr 17.
Article in English | MEDLINE | ID: covidwho-2300756

ABSTRACT

OBJECTIVES: To evaluate the outcomes of delayed intravitreal injections (IVIs) caused by the outbreak of coronavirus disease 2019 (COVID-19), in patients with neovascular age-related macular degeneration (nAMD). METHODS: nAMD patients with scheduled IVIs between March 1st and April 30th, 2020 were stratified through a risk-based selection into a non-adherent group (NA-group) if they skipped at least one IVI and an adherent group (A-group) if they followed their treatment schedule. During the pandemic visit (v0), if a significant worsening of the disease was detected, a rescue therapy of three-monthly IVIs was performed. Multimodal imaging and best-corrected visual acuity (BCVA) findings were evaluated after 6 months (v6), compared between groups and with the visit prior the lockdown (v-1). RESULTS: Two hundred fifteen patients (132 females, mean age: 81.89 ± 5.98 years) delayed their scheduled IVI while 83 (53 females, mean age: 77.92 ± 6.06 years) adhered to their protocol. For both groups, BCVA at v0 was significantly worse than v-1 (mean 4.15 ± 7.24 ETDRS letters reduction for the NA-group and 3 ± 7.96 for the A-group) but remained stable at v6. The two groups did not significantly differ in BCVA trends after 6 months and neither for development of atrophy nor fibrosis. CONCLUSIONS: A risk-based selection strategy and a rescue therapy may limit the long-term outcomes of an interruption of the treatment protocol in patients with nAMD.


Subject(s)
COVID-19 , Macular Degeneration , Wet Macular Degeneration , Aged , Aged, 80 and over , Female , Humans , Angiogenesis Inhibitors/therapeutic use , Communicable Disease Control , Intravitreal Injections , Macular Degeneration/drug therapy , Pandemics , Ranibizumab/therapeutic use , Treatment Outcome , Wet Macular Degeneration/drug therapy , Male
3.
PLoS One ; 17(11): e0275611, 2022.
Article in English | MEDLINE | ID: covidwho-2287938

ABSTRACT

PURPOSE: This study aimed to establish the efficacy, safety, and immunogenicity equivalence of the proposed biosimilar CKD-701 with the reference ranibizumab in patients with treatment-naïve neovascular age-related macular degeneration (nAMD). PATIENTS AND METHODS: A total of 312 participants with active subfoveal choroidal neovascularization were randomly assigned to either the CKD-701 (n = 156) or reference ranibizumab (n = 156) arms. The initial 3-month loading intraocular injections were followed by pro re nata (PRN) dosing for 9 months. The primary outcome was the proportion of patients with less than 15-letters of corrected visual acuity (BCVA) loss at 3 months visit (one month after last loading injection) compared to the baseline time point. The presence of retinal fluid, and changes in BCVA and central retinal thickness (CRT) were assessed as secondary efficacy outcomes. Immunogenicity and safety were evaluated in both treatment arms. RESULTS: In the CKD-701 arm, 143 (97.95%) patients lost <15 letters in the BCVA at 3 months compared to 143 (98.62%) in the reference arm (P = 0.67). The BCVA improved with a mean improvement of +7.0 (CKD-701) and +6.2 (ranibizumab) letters at 3 months (P = 0.43). The least-squares mean (SE) changes in CRT at 3 months from the baseline were -119.3 (12.0) µm and -124.5 (11.9) µm in the CKD-701 and ranibizumab groups, respectively (P = 0.74). The proportion of participants with subretinal or intraretinal fluid at 3, 6, and 12 months was similar between the study arms. The number (SE) of injections were 8.36 (3.13) in the CKD-701 and 8.26 (2.92) in ranibizumab (P = 0.62). The occurrence of adverse events and antidrug antibody in the study arms were also not statistically different. CONCLUSION: CKD-701 is a biosimilar to the reference ranibizumab in terms of efficacy, safety, and immunogenicity for the treatment of patients with nAMD. Moreover, improvement and maintenance of visual outcome were achieved through PRN regimen.


Subject(s)
Biosimilar Pharmaceuticals , Macular Degeneration , Renal Insufficiency, Chronic , Wet Macular Degeneration , Humans , Ranibizumab/adverse effects , Biosimilar Pharmaceuticals/adverse effects , Angiogenesis Inhibitors/therapeutic use , Intravitreal Injections , Visual Acuity , Tomography, Optical Coherence , Macular Degeneration/drug therapy , Macular Degeneration/chemically induced , Renal Insufficiency, Chronic/drug therapy , Renal Insufficiency, Chronic/chemically induced , Treatment Outcome , Wet Macular Degeneration/drug therapy
4.
BMJ Open ; 13(2): e069443, 2023 02 01.
Article in English | MEDLINE | ID: covidwho-2223674

ABSTRACT

INTRODUCTION: Neovascular age-related macular degeneration (nAMD) management is one of the largest single-disease contributors to hospital outpatient appointments. Partial automation of nAMD treatment decisions could reduce demands on clinician time. Established artificial intelligence (AI)-enabled retinal imaging analysis tools, could be applied to this use-case, but are not yet validated for it. A primary qualitative investigation of stakeholder perceptions of such an AI-enabled decision tool is also absent. This multi-methods study aims to establish the safety and efficacy of an AI-enabled decision tool for nAMD treatment decisions and understand where on the clinical pathway it could sit and what factors are likely to influence its implementation. METHODS AND ANALYSIS: Single-centre retrospective imaging and clinical data will be collected from nAMD clinic visits at a National Health Service (NHS) teaching hospital ophthalmology service, including judgements of nAMD disease stability or activity made in real-world consultant-led-care. Dataset size will be set by a power calculation using the first 127 randomly sampled eligible clinic visits. An AI-enabled retinal segmentation tool and a rule-based decision tree will independently analyse imaging data to report nAMD stability or activity for each of these clinic visits. Independently, an external reading centre will receive both clinical and imaging data to generate an enhanced reference standard for each clinic visit. The non-inferiority of the relative negative predictive value of AI-enabled reports on disease activity relative to consultant-led-care judgements will then be tested. In parallel, approximately 40 semi-structured interviews will be conducted with key nAMD service stakeholders, including patients. Transcripts will be coded using a theoretical framework and thematic analysis will follow. ETHICS AND DISSEMINATION: NHS Research Ethics Committee and UK Health Research Authority approvals are in place (21/NW/0138). Informed consent is planned for interview participants only. Written and oral dissemination is planned to public, clinical, academic and commercial stakeholders.


Subject(s)
Angiogenesis Inhibitors , Macular Degeneration , Humans , Angiogenesis Inhibitors/therapeutic use , Critical Pathways , State Medicine , Artificial Intelligence , Retrospective Studies , Macular Degeneration/drug therapy
5.
Br J Ophthalmol ; 106(12): 1762-1766, 2022 12.
Article in English | MEDLINE | ID: covidwho-2137573

ABSTRACT

PURPOSE: To assess the safety of intravitreally applied epidermal growth factor (EGF). METHODS: The clinical interventional, prospective, single-centre, case series study included patients with age-related macular degeneration-related geographic atrophy (GA), in whom the eye with the worse best-corrected visual acuity (BCVA) underwent a single, or repeated, intravitreal injection of EGF (0.75 µg in 50 µL). At baseline and afterwards, the eyes underwent ophthalmological examinations. RESULTS: The study included seven patients (mean age:70.0±12.2 years (range: 54-86 years), with five patients receiving a single injection and two patients receiving two intravitreal injections in an interval of 4 weeks. Mean duration of follow-up was 97±97 days (median:35 days; range: 7-240 days). Mean BCVA was lower at baseline than at study end (1.41±0.44 logMAR vs 0.97±0.12 logMAR; p=0.03). Mean size of the GA lesions did not differ significantly between baseline and study end (29 212±22 887 pixels vs 29 300±22 905 pixels; p=0.59) nor did the mean perimetric mean defect (-10.3±5.9 dB vs 12.0±8.8 dB; p=0.35) or the electroretinographical b-wave amplitude (44.53±31.7 µV vs 64.5±25.5 µV; p=0.12). After a second injection 4 weeks after the first injection, one of two patients developed a cystoid macular oedema in association with an induced incomplete posterior vitreous detachment. It persisted for 3 weeks. Visual acuity in this eye improved from 1.0 logMAR at baseline to 0.80 logMAR at study end. CONCLUSIONS: Except for one eye with temporary, self-resolving cystoid macular oedema, single and repeated intravitreal applications of EGF (0.75 µg) in patients with GA did not lead to intraocular inflammations or any observed intraocular side effect. TRIAL REGISTRATION NUMBER: ISRCTN12733334.


Subject(s)
Macular Degeneration , Macular Edema , Humans , Middle Aged , Aged , Aged, 80 and over , Macular Edema/drug therapy , Bevacizumab/therapeutic use , Epidermal Growth Factor/therapeutic use , Angiogenesis Inhibitors/therapeutic use , Prospective Studies , Tomography, Optical Coherence , Antibodies, Monoclonal, Humanized/therapeutic use , Vascular Endothelial Growth Factor A , Macular Degeneration/diagnosis , Macular Degeneration/drug therapy
6.
Int Ophthalmol ; 42(8): 2493-2499, 2022 Aug.
Article in English | MEDLINE | ID: covidwho-1959037

ABSTRACT

PURPOSE: Patients with age-related macular degeneration (ARMD) are required to follow a treatment protocol that requires regular follow-ups. The COVID-19 pandemic has created an additional burden for patients with ARMD under treatment with anti-vascular endothelial growth factor (anti-VEGF) injections, since patients face a congestion of the health system and closing of the outpatient services. This study examines the impact of the uncertainty regarding patients' treatment on their sense of well-being. METHODS: This is a longitudinal cohort study of eighty patients who were followed during the year following the outbreak of the COVID pandemic. Patients reported their sense of well-being with the WHO-5 questionnaire and their perception and fears for the impact of the pandemic on their ongoing ARMD treatment. RESULTS: There was a significant drop in mental well-being during the pandemic that paralleled the self-reported impact of the pandemic on ARMD treatment. Patients who reported a higher impact of COVID-19 on their treatment had experienced a higher drop in mental wellbeing compared to those who hadn't, with female gender being an additional risk factor. Objective measurements of visual acuity did not factor in the drop of sense of well-being. CONCLUSIONS: The high initial level of uncertainty regarding ARMD patients' long-term course was further exacerbated when exposed to additional uncertainties during the pandemic regarding their standard of care. Planning ahead for continuation of services and close contact with patients during similar health emergencies is of paramount importance.


Subject(s)
COVID-19 , Macular Degeneration , Angiogenesis Inhibitors/therapeutic use , COVID-19/epidemiology , Female , Humans , Intravitreal Injections , Longitudinal Studies , Macular Degeneration/drug therapy , Pandemics , Visual Acuity
7.
BMC Ophthalmol ; 22(1): 228, 2022 May 20.
Article in English | MEDLINE | ID: covidwho-1902365

ABSTRACT

BACKGROUND: During the first wave of the coronavirus disease 2019 (COVID-19) pandemic in 2020 outpatient care of neovascular age-related macular degeneration (nAMD) patients was severely reduced due to lockdown. Missed visits are known to be detrimental to patients in need of continued anti-vascular endothelial growth factor (VEGF) intravitreal injections (IVIs). The purpose of the study was to assess the effect of a month-long pause of regular visits and anti-VEGF IVIs in nAMD patients. METHODS: A retrospective study was performed. Patients were treated in a pro re nata ("as needed") scheme. Distance (logMAR) and near (logRAD) visual acuity (VA), optical coherence tomography, delay between planned and actual visit date and the indication for IVI were assessed for 3 continous visits in the 6 months before lockdown (V-3, -2, -1) and the 2 visits after lockdown (V0, V + 1). For analysis of long-term impact, records for visits 1 years before and after lockdown (V-3, V + 2) were gathered. RESULTS: We included 166 patients (120 female, 46 male) with a median (range) age of 80.88 (59.8-99.36) years. Compared to V-1, distance VA was significantly worse at both V0 (0.27 ± 0.21 vs 0.31 ± 0.23 logMAR, p < 0.001) and V + 1 (0.27 ± 0.21 vs 0.30 ± 0.23 logMAR, p = 0.021). Near VA was significantly worse at both V0 (0.31 ± 0.21 vs 0.34 ± 0.22 logRAD, p = 0.037) and V + 1 (0.31 ± 0.21 vs 0.34 ± 0.22 logRAD, p = 0.02). Visit delay (VD) at V0 was significantly longer than at V + 1 (30.81 ± 20.44 vs 2.02 ± 6.79 days, p < 0.0001). Linear regression analysis showed a significant association between visit delay and a reduction of near VA between V-1 and V + 1 (p = 0.0223). There was a significant loss of distance VA (p = 0.02) in the year after the lockdown period (n = 125) compared to the year before. Loss of reading acuity was not significantly increased (p = 0.3). One year post lockdown, there was no correlation between VA change and visit delay after lockdown (p > 0.05). CONCLUSIONS: In nAMD patients whose visits and treatment were paused for a month during the first wave of the COVID-19 pandemic, we found a loss of VA immediately after lockdown, which persisted during follow-up despite re-established anti-VEGF treatment. In the short term, length of delay was predictive for loss of reading VA. The comparison of development of VA during the year before and after the lockdown showed a progression of nAMD related VA loss which may have been accelerated by the disruption of regular visits and treatment. TRIAL REGISTRATION: This article does not report the outcome of a health care intervention. This retrospective study was therefore not registered in a clinical trials database.


Subject(s)
COVID-19 , Macular Degeneration , Wet Macular Degeneration , Aged, 80 and over , Angiogenesis Inhibitors/therapeutic use , COVID-19/epidemiology , Communicable Disease Control , Female , Follow-Up Studies , Humans , Intravitreal Injections , Macular Degeneration/drug therapy , Male , Pandemics , Ranibizumab/therapeutic use , Retrospective Studies , Vascular Endothelial Growth Factor A , Wet Macular Degeneration/drug therapy , Wet Macular Degeneration/epidemiology
8.
BMJ Open ; 12(6): e058266, 2022 06 15.
Article in English | MEDLINE | ID: covidwho-1902003

ABSTRACT

OBJECTIVES: In order to better understand the continued barriers to the provision of vascular endothelial inhibitor therapy, this study aims to investigate patients' experiences with neovascular age-related macular degeneration (nvAMD) in Germany during the injection process and how they deal with it. DESIGN AND PARTICIPANTS: This analysis is part of the qualitative arm of a wider mixed-methods study. We recruited participants all over Germany via ophthalmologists, eye clinics, general practitioners, care bases and support groups between June 2018 and December 2020 and selected a subsample of study participants with nvAMD who were either undergoing or had previously undergone vascular endothelial growth factor inhibitor therapy. We conducted narrative, semistructured, face-to-face interviews at the participants' homes, which were audio-recorded. The interviews were thematically analysed. RESULTS: Twenty-two participants were included in this analysis. Experiencing neovascular macular degeneration was dominated by the injection experience. Study participants perceived the treatment with vascular endothelial inhibitor injections as uncomfortable, and they described undergoing varying levels of anxiety during the whole injection process. After some years of receiving multiple injections, the pain and not experiencing any positive effects made participants with significant vision loss want to discontinue therapy. Furthermore, they narrated negative injection experiences in association with their interactions with medical staff and doctors. CONCLUSION: Although time in the medical setting is limited, efficient and good doctor-patient relationships seem crucial for satisfying care experiences. A respectful and humane relationship may be one key to achieving treatment adherence.


Subject(s)
Intravitreal Injections , Macular Degeneration , Wet Macular Degeneration , Angiogenesis Inhibitors/therapeutic use , Germany , Humans , Intravitreal Injections/psychology , Macular Degeneration/drug therapy , Macular Degeneration/psychology , Qualitative Research , Ranibizumab , Vascular Endothelial Growth Factor A/antagonists & inhibitors , Vascular Endothelial Growth Factor A/therapeutic use , Wet Macular Degeneration/drug therapy , Wet Macular Degeneration/psychology
9.
Int Ophthalmol ; 42(11): 3387-3395, 2022 Nov.
Article in English | MEDLINE | ID: covidwho-1859041

ABSTRACT

PURPOSE: COVID-19 emerged in the end of 2019 and was declared a worldwide pandemic shortly after. Social distancing and lockdowns resulted in lower compliance in intravitreal injections and office visits. We aimed to assess clinical outcomes among patients who missed these visits compared to those who arrived as planned. METHODS: Patients who missed or were late to office visits or intravitreal injections were defined as non-adherent and were compared to adherent patients. Our main outcomes were the need for subsequent injections, mean change in best-corrected visual acuity (BCVA), and central macular thickness (CMT). RESULTS: This study included 77 patients (24 adherent and 53 non-adherent). The mean BCVA remained stable during the study period for the adherent group (p = 0.159) and worsened in the non-adherent group (p < 0.001). Changes in CMT and maximum thickness were not significant for either group. A higher proportion of patients in the non-adherent group needed subsequent intravitreal injections (49% vs 20%, p = 0.014). CONCLUSION: The findings demonstrate the negative implications of the COVID-19 pandemic and the effect of deferring bevacizumab injections among individuals with age-related macular degeneration. This emphasizes the importance of a scheduled follow-up, also during a pandemic.


Subject(s)
COVID-19 , Macular Degeneration , Humans , Bevacizumab , Intravitreal Injections , COVID-19/epidemiology , Pandemics , Angiogenesis Inhibitors , Visual Acuity , Tomography, Optical Coherence , Communicable Disease Control , Macular Degeneration/drug therapy , Macular Degeneration/epidemiology , Treatment Outcome , Follow-Up Studies
10.
Curr Opin Pharmacol ; 64: 102231, 2022 06.
Article in English | MEDLINE | ID: covidwho-1797024

ABSTRACT

Coronavirus disease (COVID-19) outbreak has caused unprecedented global disruption since 2020. Approximately 238 million people are affected worldwide where the elderly succumb to mortality. Post-COVID syndrome and its side effects have popped up with several health hazards, such as macular degeneration and vision loss. It thus necessitates better medical care and management of our dietary practices. Natural flavonoids have been included in traditional medicine and have also been used safely against COVID-19 and several other diseases. Kaempferol is an essential flavonoid that has been demonstrated to influence several vital cellular signaling pathways involved in apoptosis, angiogenesis, inflammation, and autophagy. In this review, we emphasize the plausible regulatory effects of Kaempferol on hallmarks of COVID-19 and macular degeneration.


Subject(s)
COVID-19 Drug Treatment , Macular Degeneration , Retinal Diseases , Aged , Flavonoids/therapeutic use , Humans , Kaempferols/pharmacology , Kaempferols/therapeutic use , Macular Degeneration/drug therapy , Macular Degeneration/metabolism , Retina/metabolism , Retinal Diseases/drug therapy
11.
BMJ Open ; 12(4): e057269, 2022 04 15.
Article in English | MEDLINE | ID: covidwho-1794495

ABSTRACT

OBJECTIVES: To report the reduction in new neovascular age-related macular degeneration (nAMD) referrals during the COVID-19 pandemic and estimate the impact of delayed treatment on visual outcomes at 1 year. DESIGN: Retrospective clinical audit and simulation model. SETTING: Multiple UK National Health Service (NHS) ophthalmology centres. PARTICIPANTS: Data on the reduction in new nAMD referrals were obtained from four NHS Trusts comparing April 2020 with April 2019. To estimate the potential impact on 1-year visual outcomes, a stratified bootstrap simulation model was developed drawing on an electronic medical records dataset of 20 825 nAMD eyes from 27 NHS Trusts. MAIN OUTCOME MEASURES: Simulated mean visual acuity and proportions of eyes with vision ≤6/60, ≤6/24 and ≥6/12 at 1 year under four hypothetical scenarios: 0-month, 3-month, 6-month and 9-month treatment delays. Estimated additional number of eyes with vision ≤6/60 at 1 year nationally. RESULTS: The number of nAMD referrals dropped on average by 72% (range 65%-87%). Simulated 1-year visual outcomes for 1000 nAMD eyes with a 3-month treatment delay suggested an increase in the proportion of eyes with vision ≤6/60 from 15.5% (13.2%-17.9%) to 23.3% (20.7%-25.9%), and a decrease in the proportion of eyes with vision ≥6/12 (driving vision) from 35.1% (32.1%-38.1%) to 26.4% (23.8%-29.2%). Outcomes worsened incrementally with longer modelled delays. Assuming nAMD referrals are reduced to this level for 1 month nationally, these simulated results suggest an additional 186-365 eyes with vision ≤6/60 at 1 year. CONCLUSIONS: We report a large decrease in nAMD referrals during the COVID-19 lockdown and provide an important public health message regarding the risk of delayed treatment. As a conservative estimate, a treatment delay of 3 months could lead to a >50% relative increase in the number of eyes with vision ≤6/60 and 25% relative decrease in the number of eyes with driving vision at 1 year.


Subject(s)
COVID-19 , Macular Degeneration , Wet Macular Degeneration , Angiogenesis Inhibitors , COVID-19/epidemiology , Clinical Audit , Communicable Disease Control , Humans , Intravitreal Injections , Macular Degeneration/drug therapy , Macular Degeneration/epidemiology , Pandemics , Ranibizumab/therapeutic use , Retrospective Studies , State Medicine , Treatment Outcome , United Kingdom/epidemiology , Vision Disorders , Wet Macular Degeneration/drug therapy , Wet Macular Degeneration/epidemiology
12.
Sci Rep ; 12(1): 2789, 2022 02 18.
Article in English | MEDLINE | ID: covidwho-1699128

ABSTRACT

Neovascular age-related macular degeneration (nAMD) is a progressive retinal disease that often leads to severe and permanent vision loss. Early initiation of anti-vascular endothelial growth factor (anti-VEGF) therapy has been shown to preserve vision in nAMD patients. Concurrently, treatment outcomes in real-world are inferior to those reported in clinical trials. The most likely reasons observed are fewer treatment-intensity in routine clinical practice than in clinical trials. The other possibility could be the delay in starting treatment and the re-treatment interval. Although a negative impact of aforementioned parameters seems obvious, quantitative impact measures remain elusive in a real-world setting due to a lack of an 'optimal treatment' control group. To overcome this shortcoming, we developed, validated, and applied a model to assess and quantify the impact of anti-VEGF administration variables on visual acuity development in a prospective nAMD patient cohort. The model was further applied to probe the impact of the COVID-19 pandemic on visual progressions in nAMD patients. The presented model paves the way to systematically explore and evaluate realistic interventions in the current treatment paradigm, that can be adopted in routine clinical care.


Subject(s)
Angiogenesis Inhibitors/administration & dosage , Macular Degeneration/drug therapy , Models, Theoretical , Outcome Assessment, Health Care/methods , Ranibizumab/administration & dosage , Aged , Aged, 80 and over , COVID-19 , Female , Humans , Intravitreal Injections , Male , Prospective Studies
13.
Ophthalmologica ; 245(4): 385-392, 2022.
Article in English | MEDLINE | ID: covidwho-1673576

ABSTRACT

INTRODUCTION: The increasing high prevalence of neovascular age-related macular degeneration (nvAMD) in the aging population combined with the need for frequent monitoring and treatment for many years, especially in the COVID-19 era, raises the need to establish an effective, reliable, and safe follow-up and treatment model. This study evaluates the difference in treatment decisions comparing between the gold standard face-to-face clinical examination and virtual evaluation approach based only on visual acuity (VA) and optical coherence tomography (OCT) scans without clinical fundoscopic examination in nvAMD patients. METHODS: A single-center retrospective cohort study was conducted that compared an original "face-to-face" visit treatment decision regarding the need for anti-vascular endothelial growth factor drug, interval, and treatment regimen based on routine VA, spectral domain OCT imaging, and dilated fundus examination to two "virtual" treatment decisions based on evaluation of OCT scans and previous medical records before and after revealing VA data on the same nvAMD patients eyes. RESULTS: About 169 eyes of 114 patients were included in the study. Forty-nine patients (43%) suffered from bilateral nvAMD and had both eyes included in the study. Agreement between the "face-to-face visit treatment decision" and "virtual treatment decision" was noted in 74.6% and 71.6% eyes before and after revealing the patient's VA in the study visit, respectively. CONCLUSIONS: Virtual evaluation results in similar treatment decisions for nvAMD patients compared to standard face-to-face clinical examination.


Subject(s)
COVID-19 , Macular Degeneration , Wet Macular Degeneration , Aged , Angiogenesis Inhibitors/therapeutic use , COVID-19/epidemiology , Humans , Intravitreal Injections , Macular Degeneration/drug therapy , Ranibizumab/therapeutic use , Retrospective Studies , Tomography, Optical Coherence/methods , Visual Acuity , Wet Macular Degeneration/diagnosis , Wet Macular Degeneration/drug therapy
14.
Graefes Arch Clin Exp Ophthalmol ; 260(6): 1907-1914, 2022 Jun.
Article in English | MEDLINE | ID: covidwho-1616128

ABSTRACT

PURPOSE: To assess the impact of COVID-19-related delay in intravitreal injection timing on macular structure and visual acuity (VA) among patients treated for neovascular age-related macular degeneration (nvAMD). METHODS: We reviewed demographic and clinical data and macular ocular computerized tomographic images of 34 patients (48 eyes, group A) who did not follow their injection schedule during the first wave of COVID-19 and compared them to 46 patients (71 eyes, group B) who did. Functional worsening was defined as a loss of at least 0.1 in decimal VA. Anatomic worsening was defined as new or increased subretinal/intraretinal fluids or new hemorrhage. RESULTS: The planned mean ± standard deviation intervals between the intravitreal injections were 5.7 ± 2.7 weeks for group A and 5.5 ± 2.4 weeks for group B (P = 0.60). The actual intervals were 13.6 ± 6.8 (7.9 ± 5.2 weeks' delay) and 5.3 ± 2.4 weeks (no delay), respectively (P < 0.001). The best corrected visual acuity worsened in 23 group A eyes (47.9%) and in 6 group B eyes (8.5%) (odds ratio [OR] 9.97, P < 0.001). Anatomic features indicative of nvAMD worsening were detected in 31 group A eyes (64.6%) and in 16 group B eyes (22.5%) (OR 5.73, P < 0.001). A new macular hemorrhage was observed in 4 group A eyes (8.3%) and in no group B eyes (P = 0.09). CONCLUSION: Delay in timely retinal care during the COVID-19 restrictions period resulted in short-term negative outcomes, including macular bleeding, in nvAMD patients.


Subject(s)
COVID-19 , Macular Degeneration , Wet Macular Degeneration , Angiogenesis Inhibitors , Follow-Up Studies , Humans , Intravitreal Injections , Macular Degeneration/drug therapy , Ranibizumab , Tomography, Optical Coherence/methods , Treatment Outcome , Vascular Endothelial Growth Factor A , Vascular Endothelial Growth Factors , Wet Macular Degeneration/diagnosis , Wet Macular Degeneration/drug therapy
15.
Retina ; 42(4): 634-642, 2022 04 01.
Article in English | MEDLINE | ID: covidwho-1575085

ABSTRACT

PURPOSE: To investigate the visual and anatomical impact of intravitreal injection treatment deferral because of the COVID-19 lockdown on patients affected by neovascular age-related macular degeneration. METHODS: We retrospectively reviewed 314 patients (394 eyes) who were scheduled to receive the impact of intravitreal injections during the Swiss lockdown. We compared patients who continued to receive scheduled impact of intravitreal treatment without clinical consultation (Group Continue ?C"; n = 215) and patients for whom the impact of intravitreal treatment was completely deferred (Group Stop, ?S"; n = 179). Functional and anatomical parameters were collected at four time points before and after the lockdown. RESULTS: In Group C, the visual acuity at baseline and after the lockdown did not differ significantly. In Group S, the visual acuity deteriorated significantly compared with baseline and then improved slightly after the resumption of treatment, but it did not recover to baseline values. The mean central subfield thickness remained stable in Group C, whereas it increased in Group S and then returned to prelockdown values after the resumption of treatment. CONCLUSION: An "injection-only" approach was effective in managing patients with neovascular age-related macular degeneration during the pandemic lockdown, whereas patients who deferred their scheduled treatment showed partially irreversible deterioration of visual function. We recommend treatment continuation in patients with neovascular age-related macular degeneration during a lockdown.


Subject(s)
COVID-19 , Macular Degeneration , Wet Macular Degeneration , Angiogenesis Inhibitors/therapeutic use , COVID-19/epidemiology , Communicable Disease Control , Humans , Intravitreal Injections , Macular Degeneration/drug therapy , Retrospective Studies , Treatment Outcome , Wet Macular Degeneration/drug therapy
16.
Adv Ther ; 39(4): 1568-1581, 2022 04.
Article in English | MEDLINE | ID: covidwho-1530424

ABSTRACT

INTRODUCTION: To explore the impact of coronavirus disease 2019 (COVID-19) on the stability of patients with neovascular age-related macular degeneration (nAMD) receiving the treat and extend (T&E) or the pro re nata (PRN) treatment regimen and to identify indicators that may predict the disease stability of nAMD. METHODS: This is a retrospective study of patients with nAMD treated at the Second Affiliated Hospital of Harbin Medical University whose treatment schedule was interrupted at least once between 1 February and 31 May 2020. The demographic and clinical characteristics, including the best corrected visual acuity (BCVA), optical coherence tomography (OCT) features, subfoveal choroidal thickness (SFCT), interval between the last injection and the beginning of the pandemic, and the number of anti-vascular endothelial growth factor (VEGF) injections, were analyzed. RESULTS: A total of 209 stable patients with nAMD (122 eyes received the T&E regimen; 87 eyes received the PRN regimen) were identified. Compared to those who received the PRN regimen, the patients who received the T&E regimen were more stable during the first visit after COVID-19 (53.3% vs. 33.3%, P = 0.004), the BCVA was significantly better (58.5 letters vs. 56 letters, P = 0.006), and the CRT fluctuated only slightly (15 µm vs. 35 µm, P = 0.001). Furthermore, a multivariate logistic regression analysis showed that stable patients with nAMD with type 1 choroidal neovascularization (CNV) (OR 2.493 [95% CI 1.179-5.272], compared with type 2 CNV; P = 0.017; OR 2.912 [95% CI 1.133-7.485], compared with retinal angiomatous proliferation; P = 0.026) or with pigment epithelial detachment (PED) were more likely to remain stable when treatment was interrupted (OR 0.392 [95% CI 0.181-0.852], compared with no PED; P = 0.018). CONCLUSION: Compared to patients who received the PRN treatment regimen, stable patients with nAMD who received the T&E treatment regimen could better maintain stability when the treatments were suddenly interrupted by the COVID-19 pandemic. In addition, patients with type 1 CNV or patients with PED were more likely to remain stable. At present, the COVID-19 pandemic is becoming increasingly normalized, and the T&E regimen can become a more advanced treatment option for patients undergoing therapy.


Subject(s)
COVID-19 , Choroidal Neovascularization , Macular Degeneration , Retinal Detachment , Wet Macular Degeneration , Angiogenesis Inhibitors/therapeutic use , Choroidal Neovascularization/drug therapy , Humans , Intravitreal Injections , Macular Degeneration/complications , Macular Degeneration/drug therapy , Pandemics , Ranibizumab/therapeutic use , Retrospective Studies , Tomography, Optical Coherence , Treatment Outcome , Vascular Endothelial Growth Factor A/therapeutic use , Visual Acuity , Wet Macular Degeneration/complications , Wet Macular Degeneration/drug therapy
17.
JAMA Ophthalmol ; 139(5): 508-515, 2021 05 01.
Article in English | MEDLINE | ID: covidwho-1126331

ABSTRACT

Importance: Patient perceptions regarding the risks of obtaining in-person ophthalmic care during the coronavirus disease 2019 (COVID-19) pandemic may affect adherence to recommended treatment plans and influence visual outcomes. A deeper understanding of patient perspectives will inform strategies to optimize adherence with vision-preserving therapies. Objective: To evaluate perceptions of COVID-19 exposure risk and their association with appointment attendance among patients at high risk of both reversible and irreversible vision loss from lapses in care. Design, Setting, and Participants: This survey study included a nonvalidated telephone survey designed in April and May of 2020 and a retrospective medical record review conducted in parallel with survey administration from May 22 to August 18, 2020. Participants were recruited from 2 tertiary eye care centers (Emory Eye Center in Atlanta, Georgia, and W.K. Kellogg Eye Center in Ann Arbor, Michigan). The study included a random sample of patients with diagnoses of exudative age-related macular degeneration (AMD) or diabetic retinopathy (DR) who received an intravitreal injection between January 6 and March 13, 2020, and were scheduled for a second injection between March 13 and May 6, 2020. Main Outcomes and Measures: Association between perceptions regarding COVID-19 risks and loss to follow-up. Results: Of 1004 eligible patients, 423 (42%) were successfully contacted, and 348 (82%) agreed to participate (participants' mean [SD] age, 75 [12] years; 195 women [56%]; 287 White [82%] patients). Respondents had a mean (SD) of 2.7 (1.1) comorbidities associated with severe COVID-19, and 77 (22%) knew someone with COVID-19. Of all respondents, 163 (47%) were very concerned or moderately concerned about vision loss from missed treatments during the pandemic. Although 208 (60%) believed the COVID-19 virus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), exposure at the eye clinic was extremely unlikely or unlikely, 49 (14%) believed it was extremely likely or likely. Seventy-eight participants (22%) were lost to follow-up. Concern regarding COVID-19 exposure during clinic visits (odds ratio [OR], 3.9; 95% CI, 1.8-8.4) and diagnosis of DR (vs AMD) (OR, 8.130; 95% CI, 3.367-20.408) were associated with an increase in likelihood of loss to follow-up. Conclusions and Relevance: Among patients at high risk for vision loss from lapses in care, many expressed concerns regarding the effect of the pandemic on their ability to receive timely care. Survey results suggest that fear of SARS-CoV-2 exposure was associated with a roughly 4-fold increase in the odds of patient loss to follow-up. These results support the potential importance of clearly conveying infection-control measures.


Subject(s)
COVID-19/prevention & control , Diabetic Retinopathy/drug therapy , Eye Diseases/therapy , Health Knowledge, Attitudes, Practice , Macular Degeneration/drug therapy , Ophthalmic Solutions/administration & dosage , Ophthalmology , Patient Acceptance of Health Care , Aged , Aged, 80 and over , COVID-19/transmission , Diabetic Retinopathy/diagnosis , Drug Administration Schedule , Eye Diseases/diagnosis , Fear , Female , Georgia , Health Care Surveys , Humans , Intravitreal Injections , Macular Degeneration/diagnosis , Male , Michigan , Middle Aged , Patient Compliance , Retrospective Studies , Risk Assessment , Risk Factors
18.
J Fr Ophtalmol ; 44(3): 299-306, 2021 Mar.
Article in English | MEDLINE | ID: covidwho-1078009

ABSTRACT

OBJECTIVES: To investigate the effects of the COVID-19 pandemic on the treatment course of neovascular age-related macular degeneration (nAMD) patients who received anti-VEGF injection therapy with real-life data. METHODS: This retrospective study consisted of 116 eyes of 106 patients. Ophthalmic examination, assessment of best-corrected visual acuity (BCVA), optical coherence tomography (OCT) findings and data of last two visits before restrictions (V-2 and V-1) and the first visit (V0) after the release of national lockdown and subsequent visits (V1 and Vlast) were recorded. The lockdown period was determined by the time interval between March 11 and June 1, 2020. MAIN RESULTS: The injection interval before V-1 was significantly longer than the interval after V0 (2.56±0.9 vs. 2.14±0.8 months, P=0.02). While the median central macular thickness (CMT) was significantly increased at V0 compared to V-1 [274(132-711) vs. 238(136-628), P<0.001], the median CMT was significantly lower at V1 compared to V0 [256 (136-591) vs. 274(132-711), P=0.003]. The median BCVA was 0.67(0.1-1.1) logMAR at V-1 and significantly worsened to 0.78 (0.1-1.2) logMAR at V0 (P=0.003). Although the median BCVA improved to 0.69 logMAR (0.1-1.2) at Vlast, the difference did not reach statistical significance compared to V0 (P=0.08). CONCLUSION: Treatment delay due to the COVID-19 pandemic cause progression of nAMD and visual impairment. To plan more frequent anti-VEGF treatments and visits may be an appropriate approach until the disease stabilizes. However, it should be kept in mind that despite the improvement in OCT findings, the desired success in VA could not be achieved in the short term.


Subject(s)
Angiogenesis Inhibitors/therapeutic use , COVID-19/epidemiology , Macular Degeneration , Pandemics , Retinal Neovascularization , Time-to-Treatment , Aged , Aged, 80 and over , Angiogenesis Inhibitors/administration & dosage , Delayed Diagnosis/statistics & numerical data , Disease Progression , Female , Humans , Intravitreal Injections , Macular Degeneration/diagnosis , Macular Degeneration/drug therapy , Macular Degeneration/epidemiology , Macular Degeneration/pathology , Male , Pandemics/statistics & numerical data , Physical Examination/statistics & numerical data , Prognosis , Retinal Neovascularization/diagnosis , Retinal Neovascularization/drug therapy , Retinal Neovascularization/epidemiology , Retinal Neovascularization/pathology , Retrospective Studies , SARS-CoV-2 , Time-to-Treatment/statistics & numerical data , Tomography, Optical Coherence , Treatment Outcome , Turkey/epidemiology , Vascular Endothelial Growth Factor A/antagonists & inhibitors , Vascular Endothelial Growth Factor A/immunology
19.
Eur J Ophthalmol ; 31(3): 849-852, 2021 May.
Article in English | MEDLINE | ID: covidwho-835729

ABSTRACT

In the last months, a rapidly increasing number of people have been infected with severe acute respiratory syndrome coronavirus 2, the virus causing coronavirus disease 2019 (COVID-19). Due to the risk of cross-infections, the number of visits and injections was dramatically reduced in the last months, and the time between visits has been rescheduled from every 15 to 45 min, significantly impairing the total number of available visits. Although continuity of care has been allowed, a series of measures to diminish the risk of contamination need to be adopted until the end of this pandemic outbreak, which may persist until the development of an effective vaccine. For these reasons, we have introduced a new treatment regimen that is aimed at reducing the number of in-person visits and achieving continuity of treatment. This regimen is named "Triple and Plan" (TriPla). The main advantage of the TriPla regimen is to reduce the number of visits of patients in comparison to the pro re nata and treat and extend regimen. Using the TriPla regimen, the risk of contamination would be reduced. Furthermore, by reducing the number of scheduled visits, physicians could guarantee an adequate number of examinations for each patient, lengthening the interval between visits, and reducing the risk of cross-infections.


Subject(s)
COVID-19 , Macular Degeneration , Wet Macular Degeneration , Angiogenesis Inhibitors/therapeutic use , Follow-Up Studies , Humans , Intravitreal Injections , Macular Degeneration/drug therapy , Ranibizumab/therapeutic use , SARS-CoV-2 , Tomography, Optical Coherence , Treatment Outcome , Visual Acuity
20.
Eur J Ophthalmol ; 31(1): 10-12, 2021 Jan.
Article in English | MEDLINE | ID: covidwho-791664

ABSTRACT

We report our experience during COVID-19 outbreak for intravitreal injections in patients with maculopathy. We proposed a treatment priority levels and timings; the "High" priority level includes all monocular patients; the "Moderate" is assigned to all patients with an active macular neovascularization; the patients affected by diabetic macular edema or retinal vein occlusion belong to the "Low" class. This organization allowed us to treat the most urgent patients although the injections performed had a 91.7% drop compared to the same period of 2019.


Subject(s)
COVID-19/epidemiology , Disease Outbreaks , Health Priorities/organization & administration , Pharmaceutical Preparations/administration & dosage , Retinal Diseases/classification , SARS-CoV-2 , Tertiary Care Centers/organization & administration , Central Serous Chorioretinopathy/classification , Central Serous Chorioretinopathy/drug therapy , Diabetic Retinopathy/classification , Diabetic Retinopathy/drug therapy , Humans , Intravitreal Injections , Italy/epidemiology , Macular Degeneration/classification , Macular Degeneration/drug therapy , Macular Edema/classification , Macular Edema/drug therapy , Quarantine , Retinal Diseases/drug therapy , Retinal Vein Occlusion/classification , Retinal Vein Occlusion/drug therapy
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