Aflibercept or ranibizumab for diabetic macular edema.

Background: Vascular endothelial growth factor (VEGF) is the primary substance involved in retinal barrier breach. VEGF overexpression may cause diabetic macular edema (DME). Laser photocoagulation of the macula is the standard treatment for DME; however, recently, intravitreal anti-VEGF injections have surpassed laser treatment. Our aim was to evaluate the efficacy of intravitreal injections of aflibercept or ranibizumab for managing treatment-naive DME. Methods: This single-center, retrospective, interventional, comparative study included eyes with visual impairment due to treatment-naive DME that underwent intravitreal injection of either aflibercept 2 mg/0.05 mL or ranibizumab 0.5 mg/0.05 mL at Al-Azhar University Hospitals, Egypt between March 2023 and January 2024. Demographic data and full ophthalmological examination results at baseline and 1, 3, and 6 months post-injection were collected, including the best-corrected distance visual acuity (BCDVA) in logarithm of the minimum angle of resolution (logMAR) notation, slit-lamp biomicroscopy, dilated fundoscopy, and central subfield thickness (CST) measured using spectral-domain optical coherence tomography. Results: Overall, the 96 eyes of 96 patients with a median (interquartile range [IQR]) age of 57 (10) (range: 20-74) years and a male-to-female ratio of 1:2.7 were allocated to one of two groups with comparable age, sex, diabetes mellitus duration, and presence of other comorbidities (all P >0.05). There was no statistically significant difference in baseline diabetic retinopathy status or DME type between groups (both P >0.05). In both groups, the median (IQR) BCDVA significantly improved from 0.7 (0.8) logMAR at baseline to 0.4 (0.1) logMAR at 6 months post-injection (both P = 0.001), with no statistically significant difference between groups at all follow-up visits (all P >0.05). The median (IQR) CST significantly decreased in the aflibercept group from 347 (166) µm at baseline to 180 (233) µm at 6 months post-injection, and it decreased in the ranibizumab group from 360 (180) µm at baseline to 190 (224) µm at 6 months post-injection (both P = 0.001), with no statistically significant differences between groups at all follow-up visits (all P >0.05). No serious adverse effects were documented in either group. Conclusions: Ranibizumab and aflibercept were equally effective in achieving the desired anatomical and functional results in patients with treatment-naïve DME in short-term follow-up without significant differences in injection counts between both drugs. Larger prospective, randomized, double-blinded trials with longer follow-up periods are needed to confirm our preliminary results.

Randomized Trial of Biosimilar XSB-001 versus Reference Ranibizumab in Patients with Neovascular Age-Related Macular Degeneration.

OBJECTIVE: To evaluate the efficacy, safety, and immunogenicity of a ranibizumab biosimilar candidate (XSB-001) versus reference product (Lucentis) for neovascular age-related macular degeneration (nAMD). DESIGN: Phase III, multicenter, randomized, double-masked, parallel-group study. PARTICIPANTS: Patients with nAMD. METHODS: Eligible patients were randomized (1:1) to receive intravitreal injections of XSB-001 or reference ranibizumab (0.5 mg [0.05 ml]) in the study eye once every 4 weeks for 52 weeks. Efficacy and safety assessments continued through 52 weeks of treatment. MAIN OUTCOME MEASURES: Primary end point was change from baseline in best-corrected visual acuity (BCVA) by ETDRS letters at week 8. Biosimilarity was concluded if the 2-sided 90% confidence interval (CI) (United States) or 95% CI (rest of world) for the difference in least-squares (LS) mean change in BCVA at week 8 between treatment groups was within the predefined equivalence margin of ± 3.5 letters. RESULTS: In total, 582 patients (n = 292 XSB-001, n = 290 reference ranibizumab) were randomized. Mean age was 74.1 years, most patients (85.2%) were White, and 55.8% were women. Mean BCVA score at baseline was 61.7 and 61.5 ETDRS letters in the XSB-001 and reference ranibizumab groups, respectively. At week 8, the LS mean (standard error [SE]) change in BCVA from baseline was 4.6 (0.5) ETDRS letters in the XSB-001 group and 6.4 (0.5) letters in the reference ranibizumab group (LS mean [SE] treatment difference: -1.8 [0.7] ETDRS letters; 90% CI, -2.9 to -0.7; 95% CI, -3.1 to -0.5). The 90% CI and 95% CI for LS mean difference in change from baseline were within the predefined equivalence margin. At week 52, LS mean (SE) change in BCVA was 6.4 (0.8) and 7.8 (0.8) letters, respectively (LS mean [SE] treatment difference, -1.5 [1.1] ETDRS letters; 90% CI, -3.3 to 0.4; 95% CI, -3.6 to 0.7). There were no clinically meaningful differences between treatments in anatomical, safety, or immunogenicity end points through week 52. CONCLUSIONS: XSB-001 demonstrated biosimilarity to reference ranibizumab in patients with nAMD. Treatment with XSB-001 for 52 weeks was generally safe and well tolerated, with a safety profile similar to the reference product. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Physicochemical and Biological Stability Assessment of SB11 (Ranibizumab Biosimilar) Under Ambient and In-Use Storage for Intravitreal Administration.

INTRODUCTION: SB11 (Byooviz™) is a ranibizumab biosimilar that acts as a vascular endothelial growth factor (VEGF)-A inhibitor. Stability data for unopened SB11 vials at room temperature are limited and no data are available for SB11 withdrawn into syringes (in-use) for intravitreal administration. METHODS: SB11 stability was assessed in two different settings: unopened vials stored at 30 ± 2 °C/65 ± 5% relative humidity (RH) for 2 months, and in-use SB11 withdrawn into syringes stored at 5 ± 3 °C for 98 days and then 25 ± 2 °C/60 ± 5% RH for 24 h. The product was stored in the absence of light, and the experimental design followed International Conference on Harmonization and European Medicines Agency requirements for stability evaluation of biological products. Analysis included visual appearance (color, clarity, and presence of visible particles), pH, protein concentration (A280) and purity (size-exclusion high-pressure liquid chromatography, capillary electrophoresis-sodium dodecyl sulfate, imaged capillary isoelectric focusing), biological activity (VEGF binding and neutralization), and safety (sub-visible particulates). RESULTS: Except for charge variants in unopened vials at room temperature after 1 month by US standards, all results met the stability acceptance criteria (US and EU) for both unopened vials and for in-use SB11. There were no major changes in terms of physicochemical stability, biological activity and sub-visible particulates. CONCLUSION: SB11 was stable for longer periods and at higher temperatures than what is stated in the labels of the reference product (Lucentis) and SB11. The physicochemical properties, biological activity, and sub-visible particulates of SB11 in both tested settings (unopened vials at room temperature and in-use product withdrawn into syringes) were maintained under the described storage periods. This information can help to avoid unnecessary delays in patient treatment without any loss in quality and biological activity, lower the workload of health care providers and reduce costs associated with drug waste.

A prospective, randomized, parallel group, double blind, multicenter study to compare the efficacy, safety and immunogenicity of Lupin's Ranibizumab with Lucentis® in patients with neovascular age-related macular degeneration.

Purpose: The present study compares the efficacy, safety, and immunogenicity of Lupin's biosimilar ranibizumab with that of Lucentis® in patients with neovascular age-related macular degeneration. Methods: This prospective, double-blind, multi-centric phase-III study was conducted across 19 centers in India. A total of 202 patients with neovascular age-related macular degeneration were randomized (1:1) to receive either Lupin's biosimilar ranibizumab or Lucentis®, 0.5 mg, as an intravitreous injection once every month for 3 months. The primary efficacy endpoint was the proportion of patients who lost fewer than 15 letters from baseline in best-corrected visual acuity. The safety profile included assessment of adverse events, ophthalmic examination, physical and systemic examination, and vital parameters. The immunogenicity assessment was based on evaluation of anti-drug antibodies. Results: Overall, 174 patients (87 [86.14%] in each group) completed the study. The demographics and baseline characteristics were comparable between the treatment groups. The proportion of patients losing fewer than 15 letters from baseline best corrected visual acuity score in the study eye was comparable between two groups. The difference between Lupin's ranibizumab and Lucentis® for the proportion of patients who lost fewer than 15 letters was within the predefined equivalence margin (intention-to-treat population: 1.0%; 95% confidence interval [CI], -3.3% to 5.4% and per protocol population: 1.2%; 95% CI, -3.2% to 6.4%). The incidence of treatment-emergent adverse events was comparable, and 11 (10.89%) patients in Lupin's ranibizumab and 19 (18.81%) patients in Lucentis® group had at least one treatment-emergent adverse event. The immunogenicity incidence as assessed by proportion of patients with positive anti-drug antibodies was numerically lower in Lupin's ranibizumab (4.95%) than Lucentis® (12.87%). Conclusion: Lupin's biosimilar ranibizumab demonstrated therapeutic equivalence, desirable safety, and favorable immunogenicity profile compared to Lucentis®.

LUCENTIS IN THE TREATMENT OF DIABETIC MACULAR EDEMA, TWO-YEAR RESULTS.

AIM: To evaluate, on the basis of two-year observations, the effectiveness of intravitreal treatment with Ranibizumab in patients with diabetic macular edema (DME) unresponsive to the previous laser treatment. Cohort and Methods: A retrospective study evaluates 29 eyes of 29 patients with diffuse DME unresponsive to their previous laser treatment. The group of the patients consisted of 16 males (55.1%) and 13 females (44.8%); their mean age was 71.3. The mean duration of diabetes mellitus was 13 years (3-20). 19 patients (65.5%) were treated with insulin, 10 patients (34.4%) were treated with peroral antidiabetics (PAD); the mean HbA1c value was 52 mmol/l. The treatment was started with 3 initial doses of intravitreal injections of Ranibizumab 0.5 mg. There was a one- -month interval between the applications. Subsequent evaluations and administrations of the following injections were made in the pro re nata (PRN) mode; the check-ups were carried out every month during the first year and on average every 3 months in the second year. The monitored parameters: the best corrected visual acuity (BCVA) measured on ETRDS (Early Treatment Diabetic Retinopathy Study) optotypes, the central retinal thickness (CRT). These parameters were monitored prior to the treatment and then in the 3rd, 6th, 9th, 12th, 18th and 24th months. RESULTS: A statistically significant improvement in the mean value of BCVA was detected. From the initial 65.4 ±10.61 letters it improved by 11.2 letters (p.

Evaluation of the Structural, Physicochemical, and Biological Characteristics of SB11, as Lucentis® (Ranibizumab) Biosimilar.

INTRODUCTION: SB11 was recently approved as a ranibizumab biosimilar by the US Food and Drug Administration (FDA) and the European Commission (EC) as a therapy for retinal vascular disorders under the brand name Byooviz™. This study was performed to assess the analytical similarity between SB11 and reference products from the European Union (EU-ranibizumab) and United States (US-ranibizumab). METHODS: A comprehensive structural, physicochemical, and biological characterization was performed utilizing state-of-the-art analytical methods. Comparisons included the following: primary structure related to amino acid sequence and post-translational modifications; higher order structure; product-related substances and purity/impurity including size and charge variants. In addition, biological characterization included a series of mechanism of action (MoA)-related bioassays such as vascular endothelial growth factor (VEGF)-A binding assay (VEGF-A 165 and its isoforms), cell-based VEGF-A 165 neutralization assay, and anti-proliferation assay using human umbilical vein endothelial cells (HUVEC). RESULTS: The amino acid sequence of SB11 was identical to that of reference products, and post-translational modification profiles and higher order structures of SB11 were shown to be indistinguishable from the reference products. Product-related size and charge variants and aggregates were also similar. Using a broad range of VEGF-related functional assays, we demonstrated that SB11 has similar biological properties to reference products in VEGF-A binding activities (VEGF-A 165 and isoforms (VEGF-A 110, VEGF-A 121, and VEGF-A 189)), VEGF-A 165 neutralization, and HUVEC anti-proliferation. Overall, SB11 exhibits high similarity compared to EU/US-ranibizumab. CONCLUSION: Based on the comprehensive analytical similarity assessment, SB11 is highly similar to the EU/US-ranibizumab with respect to structural, physicochemical, and biological properties.

Efficacy and Safety of Biosimilar FYB201 Compared with Ranibizumab in Neovascular Age-Related Macular Degeneration.

PURPOSE: This trial was conducted to investigate the clinical equivalence of the proposed biosimilar FYB201 and reference ranibizumab in patients with treatment-naive, subfoveal choroidal neovascularization caused by neovascular age-related macular degeneration (nAMD). DESIGN: This was a prospective, multicenter, evaluation-masked, parallel-group, 48-week, phase III randomized study. PARTICIPANTS: A total of 477 patients were randomly assigned to receive FYB201 (n = 238) or reference ranibizumab (n = 239). METHODS: Patients received FYB201 or reference ranibizumab 0.5 mg by intravitreal (IVT) injection in the study eye every 4 weeks. MAIN OUTCOME MEASURES: The primary end point was change from baseline in best-corrected visual acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letters at 8 weeks before the third monthly IVT injection. Biosimilarity of FYB201 to its originator was assessed via a 2-sided equivalence test, with an equivalence margin in BCVA of 3 ETDRS letters. RESULTS: The BCVA improved in both groups, with a mean improvement of +5.1 (FYB201) and +5.6 (reference ranibizumab) ETDRS letters at week 8. The analysis of covariance (ANCOVA) least squares mean difference for the change from baseline between FYB201 and reference ranibizumab was -0.4 ETDRS letters with a 90% confidence interval (CI) of -1.6 to 0.9. Primary end point was met as the 90% CI was within the predefined equivalence margin. Adverse events were comparable between treatment groups. CONCLUSIONS: FYB201 is biosimilar to reference ranibizumab in terms of clinical efficacy and ocular and systemic safety in the treatment of patients with nAMD.

Optic nerve head perfusion changes in eyes with proliferative diabetic retinopathy treated with intravitreal ranibizumab or photocoagulation: a randomized controlled trial.

Background: Proliferative diabetic retinopathy (PDR) is a serious sight-threatening disease, and half of the patients with high-risk PDR can develop legal blindness within 5 years, if left untreated. This study was aimed at comparing panretinal photocoagulation (PRP) and intravitreal ranibizumab injections in terms of radial peripapillary capillary (RPC) density on optical coherence tomography angiography (OCTA) in patients with treatment-naive PDR. Methods: This open-label, prospective, randomized clinical trial included 50 patients with treatment-naive PDR with optic disc neovascularization and randomized them into two groups: group 1, with patients undergoing two sessions of PRP 2 weeks apart, and group 2, with patients received three intravitreal ranibizumab injections (0.5 mg) 1 month apart for 3 consecutive months. Patients underwent a full ophthalmological examination, including best-corrected distance visual acuity (BCDVA) measurement in the logarithm of minimal angle of resolution (logMAR) notation and OCTA before intervention and monthly after the last laser session or the first intravitreal ranibizumab injection for 3 months of follow-up. Visual field (VF) was tested at the beginning and end of 3 months. Results: Forty-two (84%) eyes completed the 3-month follow-up, including 22 eyes in the PRP group (88%) and 20 (80%) eyes in the ranibizumab group. The two groups were comparable in terms of demographic characteristics, diabetes duration, baseline BCDVA, glycated hemoglobin level, OCTA parameters, VF indices, and intraocular pressure (all P > 0.05). The RPC density change from baseline to the 3-month follow-up was significantly lower in the PRP group than in the ranibizumab group (mean difference in RPC density change: - 3.61%; 95% confidence interval: - 5.57% to - 1.60%; P = 0.001). The median (interquartile range) logMAR change from baseline to the 3-month follow-up (0.0 [0.2]) was significantly higher in the PRP group than in the ranibizumab group (- 0.15 [0.3]; P < 0.05). The median changes in central foveal thickness from baseline to the 3-month follow-up differed significantly between the two groups (P = 0.001). Conclusions: In eyes with PDR and neovascularization of the disc RPC density on OCTA increased in the ranibizumab group and decreased in the PRP group. Visual acuity gain was higher in the ranibizumab group than in the PRP group. Future multicenter trials addressing our limitations are required to verify the findings of this study.

Visual Outcome of Anti-vascular Endothelial Growth Factor Injections at the University College Hospital, Ibadan.

Aim: The aim of the study was to evaluate the 1-year outcome of intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy in an eye unit in sub-Saharan Africa. Methodology: This retrospective study included 182 eyes of 172 patients managed in the vitreoretinal unit between 2016 and 2019 who were treated with intravitreal anti-VEGF bevacizumab (1.25 mg/0.05 ml) with at least 1 year of follow-up. The outcome measures were change in best-corrected visual acuity (BCVA) over 1 year of follow-up, the number of injections taken, and complications. Results: The mean age was 61.1 ± 16.3 years (male-to-female ratio of 1:1.1) and about 62.1% above >60 years. A total of 330 injections were given during the period audited. The mean number of injections was 1.8 ± 0.93. Ninety-four (51.7%) eyes had only one injection, while 33 (18.1%), 50 (27.5%), and 5 (2.7%) had 2, 3, and 4 injections, respectively. About 78.5% had moderate-to-severe visual impairment at baseline and 44.5%, 16.4%, 12.6%, and 7.1% at 1, 3, 6, and 12 months post injections, respectively. The mean BCVA improved for all eyes from 1.67 ± 0.91 logarithm of minimum angle of resolution (logMAR) at baseline to 1.50 ± 1.27 logMAR at 1 year. The logMAR letters gained was 23 at 1 month and 8.25 at 1 year; the eyes that had three injections gained 10 letters, while those that had one injection gained three letters. Eyes with age-related macular degeneration and idiopathic polypoidal choroidopathy gained 7.5 and 9 letters, respectively, at 1 year after at least three injections. There was a statistically significant association between an increasing number of injections and improved visual outcome (P = 0.043). One patient each developed endophthalmitis (0.6%) and inferior retinal detachment (0.6%) post injection. Conclusion: Visual acuity gain was recorded in patients who had intravitreal anti-VEGF injections in 1 year. It is recommended that patients should have more than one injection.

RésuméObjectif: Le but de l'étude était d'évaluer le résultat à 1 an d'un traitement intravitréen anti-facteur de croissance endothélial vasculaire (anti VEGF) dans une unité ophtalmologique en Afrique subsaharienne. Méthodologie: Cette étude rétrospective a inclus 182 yeux de 172 patients pris en charge dans l'unité vitréorétinienne entre 2016 et 2019 qui ont été traités par bevacizumab anti-VEGF intravitréen (1,25 mg/0,05 ml) avec au moins 1 an de suivi. Les mesures des résultats étaient le changement de la meilleure acuité visuelle corrigée (MAVC) sur 1 an de suivi, le nombre d'injections effectuées et les complications. Résultats: L'âge moyen était de 61,1 ± 16,3 ans (ratio homme/femme de 1:1,1) et d'environ 62,1 % au-dessus de > 60 ans. Au total, 330 injections ont été effectuées au cours de la période auditée. Le nombre moyen d'injections était de 1,8 ± 0,93. Quatre-vingt quatorze yeux (51,7 %) n'ont eu qu'une seule injection, tandis que 33 (18,1 %), 50 (27,5 %) et 5 (2,7 %) ont eu 2, 3 et 4 injections, respectivement. Environ 78,5% avaient une déficience visuelle modérée à sévère au départ et 44,5%, 16,4%, 12,6% et 7,1% à 1, 3, 6 et 12 mois après les injections, respectivement. La MAVC moyenne s'est améliorée pour tous les yeux, passant de 1,67 ± 0,91 logarithme de l'angle minimal de résolution (logMAR) au départ à 1,50 ± 1,27 logMAR à 1 an. Les lettres logMAR acquises étaient de 23 à 1 mois et de 8,25 à 1 an ; les yeux qui ont eu trois injections ont gagné 10 lettres, tandis que ceux qui ont eu une injection ont gagné trois lettres. Les yeux atteints de dégénérescence maculaire liée à l'âge et de choroïdopathie polypoïdale idiopathique ont gagné 7,5 et 9 lettres, respectivement, à 1 an après au moins trois injections. Il y avait une association statistiquement significative entre un nombre croissant d'injections et une amélioration des résultats visuels (P = 0,043). Un patient a développé une endophtalmie (0,6 %) et un décollement de la rétine inférieure (0,6 %) après l'injection. Conclusion: Un gain d'acuité visuelle a été enregistré chez les patients ayant eu des injections intravitréennes d'anti VEGF en 1 an. Il est recommandé que les patients aient plus d'une injection. Mots-clés: Anti facteur de croissance endothélial vasculaire, bevacizumab (Avastin), injections intravitréennes, ranibizumab (Lucentis), rétine, résultat visuel Dernière modification.

Narrative review of artificial intelligence in diabetic macular edema: Diagnosis and predicting treatment response using optical coherence tomography.

Diabetic macular edema (DME), being a frequent manifestation of DR, disrupts the retinal symmetry. This event is particularly triggered by vascular endothelial growth factors (VEGF). Intravitreal injections of anti-VEGFs have been the most practiced treatment but an expensive option. A major challenge associated with this treatment is determining an optimal treatment regimen and differentiating patients who do not respond to anti-VEGF. As it has a significant burden for both the patient and the health care providers if the patient is not responding, any clinically acceptable method to predict the treatment outcomes holds huge value in the efficient management of DME. In such situations, artificial intelligence (AI) or machine learning (ML)-based algorithms come useful as they can analyze past clinical details of the patients and help clinicians to predict the patient's response to an anti-VEGF agent. The work presented here attempts to review the literature that is available from the peer research community to discuss solutions provided by AI/ML methodologies to tackle challenges in DME management. Lastly, a possibility for using two different types of data has been proposed, which is believed to be the key differentiators as compared to the similar and recent contributions from the peer research community.

Effect analysis of the intravitreal Conbercept in the treatment of choroid neovascularization of macular with high myopia / 国际眼科杂志(Guoji Yanke Zazhi)

@#AIM: To explore the effect of intravitreal conbercept in the treatment of chorionic neovascularization(CNV)of macular macula with high myopia. <p>METHODS: Totally 56 patients with high myopia caused by macular angiogenesis in our hospital were retrospectively selected as the research objects from June 2015 to December 2019. According to the treatment methods, patients were divided into the control group and the observation group. The 28 cases(28 eyes)of patients in the control group were treated with the intravitreous injection of Rayzumab, and 28 cases(28 eyes)of patients in the observation group were treated with intravitreal injection of conbercept. After the last treatment, the patients were followed up for 3mo to record the intraocular pressure, the best corrected visual acuity(BCVA)and the incidence of complications. Optical coherence tomography(OCT)was used to measure the thickness of macular fovea retinal(CMT), and horizontal linear scanning of OCT instrument was used to measure the CNV area.<p>RESULTS:After treatment, the visual acuity of patients in the observation group gradually increased, and the improvement of BCVA was significantly higher than that of the control group at the same time point(<i>P</i><0.05). After 3mo of treatment, it showed that IOP, CNV area and CMT in the observation group were significantly reduced after the combined treatment, and the improvement was better than that in the control group(<i>P</i><0.05). The incidence of complications in the observation group(4%)was significantly lower than that in the control group(18%).<p>CONCLUSION:The treatment of intravitreal conbercept injection for the high myopia CNV was superior to lucentis, which could improve clinical efficacy by increasing BCVA, reducing CMT thickness, improving vision and reducing postoperative complications.

Thrombotic Microangiopathy and Acute Kidney Injury Induced After Intravitreal Injection of Vascular Endothelial Growth Factor Inhibitors VEGF Blockade-Related TMA After Intravitreal Use.

Vascular endothelial growth factor (VEGF) inhibition can cause worsening hypertension, proteinuria, chronic kidney injury, and glomerular disease. Thrombotic microangiopathy (TMA) and other nephrotic disorders have been reported with systemic VEGF blockade. These same agents are given intravitreally for age-related macular degeneration (AMD) and diabetic retinopathy (DR), albeit at lower doses than those given for systemic indications. Systemic absorption of anti-VEGF agents when given intravitreally has been shown consistently along with evidence of significant intravascular VEGF suppression. While worsening hypertension has only been seen in some large-scale studies, case reports show worsening proteinuria and diverse glomerular diseases. These include TMA-associated lesions like focal and segmental glomerulosclerosis with collapsing features (cFSGS). In this paper, we report three cases of TMA likely associated with the use of intravitreal anti-VEGF therapy. These patients developed the signature lesion of VEGF blockade in a 6 to 11 month time frame after starting intravitreal VEGF inhibitors. The literature is reviewed showing similar cases. Intravitreal VEGF blockade may cause these adverse events in a hitherto unidentified subgroup of patients. Well-controlled prospective observational trials are needed to determine the event rate and identify which subgroups of patients are at increased risk. A registry for patients who develop worsening hypertension, proteinuria exacerbation, and glomerular diseases from intravitreal VEGF blockade is proposed.

Efficacy of intravitreal Lucentis injection on major and macular branch retinal vein occlusion.

BACKGROUND: The objective of our study was to assess the efficacy of intravitreal Lucentis injection on major and macular branch retinal vein occlusion (BRVO). METHODS: In this retrospective analysis, 43 patients (major BRVO n = 24; macular BRVO, n = 19) were treated with intravitreal injection of Lucentis with a 1 + PRN regimen, which is diagnosed by fluorescein fundus angiography (FFA). "1 + PRN", namely, one intravitreal injection of Lucentis at the baseline, and then continue or stop according to the condition of the patient. The following observation indexes were measured at baseline and follow-up (1-6 months): best corrected visual acuity (BCVA), foveal thickness (CFT), total retinal volume with macular diameter of 6 mm. During the follow-up, repeated injections were given according to patients' demand, and the number of injections was recorded. RESULT: The observation indexes of patients with BRVO were significantly improved after 6 months of Lucentis treatment in both major and macular groups, including BCVA, CFT and the retinal volume of the 6 mm-diameter macula. Interestingly, there were significant differences in the therapeutic effect between the two groups, and the macular group had better therapeutic effect than the major group with the less number of repeated injections. CONCLUSIONS: To sum up, intravitreal injection of Lucentis was effective for both major and macular BRVO, and the efficacy in macular subtype group was better than that in major subtype group with the more obviously improvement and the less number of injections.

Evidence to date: ranibizumab and its potential in the treatment of retinopathy of prematurity.

Retinopathy of prematurity (ROP) is a leading and preventable cause of childhood blindness worldwide. Although laser photocoagulation remains the gold standard for treatment, the off-label use of anti-vascular endothelial growth factor (anti-VEGF) therapy to treat ROP, particularly posterior zone I disease, is increasing. Although initial studies on anti-VEGF therapy for ROP have focused on bevacizumab, recent studies have proposed that ranibizumab may be a safer and more effective alternative for use in this population. This review updates recent evidence regarding the use of ranibizumab in the management of ROP.

Ranibizumab for the treatment of choroidal neovascularization due to cause other than age related macular degeneration.

PURPOSE: To evaluate the safety and clinical efficacy of ranibizumab (Lucentis) in the treatment of choroidal neovascularization (CNV) caused by diseases other than age-related macular degeneration (AMD). PATIENTS: 21 patients with mean age 61  17.2 years (min 16, max 85) with CNV due to causes other than AMD, in particular pathological myopia (n=11), angioid streaks (n=3), central serous chorioretinopathy (n=2), North Carolina macular dystrophy (n=1), dominant familial drusen (n=1) and idiopathic CNV (n=3). METHODS: The patients were treated at the Ophthalmology Department of the University Hospital in Hradec Kralove with three monthly initial intravitreal injections of ranibizumab 0.5 mg with subsequent treatment regimen pro re nata (PRN). The best corrected visual acuity (BCVA) was evaluated on the ETDRS optotypes (Early Treatment Diabetic Retinopathy Study), central retinal thickness (CRT) was measured by optical coherent tomography (OCT) (Zeiss, Cirrus). These parameters were evaluated before start of the study and then at 1 (BCVA only), 4, 8, and 12 months during treatment. We also evaluated the possible occurrence of ocular and systemic side effects. RESULTS: Statistically significant improvement in the mean of BCVA score of 11.4 letters (p.

Two-year analysis of changes in the optic nerve and retina following anti-VEGF treatments in diabetic macular edema patients.

Purpose: To evaluate long-term structural and functional changes that happen to the optic nerve and retina following ranibizumab (Lucentis) injections in diabetic macular edema (DME) patients. Methods: Patients with clinically significant DME requiring anti-VEGF injections underwent pre-injection baseline, 6, 12, and 24 month follow-up tests. The tests performed were optical coherence tomography (OCT), best-corrected visual acuity (BCVA), and visual field (VF). Wide-field fluorescein angiogram (IVFA) was performed to monitor the progression of diabetic ischemia. Results: A total of 30 patients requiring anti-VEGF injections and 21 control patients not requiring anti-VEGF injections were enrolled in the study. From baseline, the average macular thickness significantly decreased (p<0.0002) over the 24-month time period. Mean perfused ratio significantly increased (p<0.0005) at 6, 12, and 24 months. Cup volume and vertical cup-to-disk ratio significantly increased (p<0.0014) over the study period. This was verified by masked independent grading of patient optic nerve stereo-photographs by glaucoma specialists. BCVA significantly (p<0.0006) improved over the study period. VFs showed a non-significant trend of deteriorating peripheral vision at 12 and 24 months. Conclusion: Clinically, anti-VEGF therapy appears to affect the optic nerve by increasing cup volume and increasing vertical cup/disk ratio over time. The results provide a cautionary note to monitor both the retina and optic nerve status in patients undergoing frequent injections.