ETOILE: Real-World Evidence of 24 Months of Ranibizumab 0.5 mg in Patients with Visual Impairment Due to Diabetic Macular Edema.

PURPOSE: To evaluate the real-world effectiveness of intravitreal ranibizumab 0.5 mg (Lucentis) in improving visual acuity (VA) in adults with decreased VA due to diabetic macular edema (DME). PATIENTS AND METHODS: Real-world prospective observational 24-month study. Ranibizumab-naïve patients (n=116) were enrolled, treated and followed up according to investigators' usual procedures. Outcomes included change from baseline to month 24 in best-corrected VA (BCVA; primary outcome), central retinal thickness (CRT), treatment exposure and safety. RESULTS: Overall, 62.9% of patients completed the study per protocol, 68.6% completed the induction phase (first three injections one month apart). On average, patients had 12.5 ophthalmologist visits and 5.74 injections in year 1, decreasing to 4.6 visits and 1.94 injections in year 2. Mean baseline BCVA was 58.4 letters, mean gain at M24 was +6.08 letters (95% CI: 2.95, 9.21). Gains were higher for patients who completed induction, and for patients who did not switch treatment. Mean CRT improved by 149.17 µm at M24. There were no new safety signals. BCVA variation of ≥6 letters by M3 was predictive of BCVA gains at M24 (p=0.007), as was hypertension medication at baseline (p=0.022). CONCLUSION: Real-world ranibizumab treatment improved VA in DME patients, despite fewer injections than recommended.

Expectations and fears of patients with diabetes and macular edema treated by intravitreal injections.

AIMS: Clinical outcomes of diabetic macular edema (DME) have been widely described, but data on diabetic retinopathy perceptions by diabetes patients are limited. The aim of this survey was to explore the lived experience, knowledge, fears and expectations about disease, and treatment in patients with diabetes and macular edema treated with intravitreal injections (IVTI) and to characterize patient profiles. METHODS: Cross-sectional survey including a preliminary qualitative phase (20 patients with DME, treated or treatment-naive, 5 female and 15 male, age 36-74 years) followed by a quantitative survey (116 patients treated with IVTI for DME). Data ASKIA Analyze (version 5.3.3.5) was used for descriptive statistics, and R software (version 3.4.1) for multiple correspondence analysis. RESULTS: The qualitative phase identified the wording used by patients and information helpful to propose modalities of response in the quantitative phase. In the quantitative survey (116 patients, mean age 66.6 years), most patients were treated with anti-vascular endothelial growth factor. Overall, 71.9% reported that the disease negatively affected their daily activities and 33.1% considered that regular visits to the ophthalmologist were disrupting their life. Treatment expectations differed significantly between patients in terms of disease experience (visit and injection schedules), fears and feelings, and relationship with physicians, allowing three patient profiles to be identified: "Worried" patients (n = 45) felt isolated and were worried about the need for repeated treatment and possible side effects. They were mainly active men aged < 60 with type I diabetes (T1D) and DME diagnosed for > 2 years; "Curious" patients (n = 21) experienced insufficient support and requested more information on their disease and existing treatments. They were mainly single women aged 60-69 years; "Passive" patients (n = 50) felt sufficiently informed by their ophthalmologist and were not concerned by DME. They were older (mean age: 70 years) and mainly type 2 diabetic men. CONCLUSIONS: Patients with diabetes and macular edema treated with IVTI form a heterogeneous group regarding fears and expectations. Different patient profiles were identified and need to be confirmed in larger studies. A better understanding of psychological profiles may optimize compliance of diabetic patients.

Evaluation of retinal function and flicker light-induced retinal vascular response in normotensive patients with diabetes without retinopathy.

PURPOSE: To correlate retinal function with vascular response to flicker light in normotensive patients with diabetes without diabetic retinopathy (DR). METHODS: Twenty-eight normotensive patients with diabetes (11 with type 1, 17 with type 2) without DR and 28 sex- and age-matched healthy control subjects underwent color vision and contrast sensitivity testing, pattern, full-field, and multifocal electroretinography, and evaluation of the vascular response to flicker light with the dynamic vessel analyzer. RESULTS: In the patients with diabetes, electroretinogram (ERG) pattern responses, b-wave in the scotopic bright flash ERG, a-wave and b-wave in the photopic single-flash ERG, and oscillatory potential responses were significantly impaired compared with those in control subjects. Vascular response to flicker light was also impaired in patients with diabetes compared with controls. In the whole population, correlations were found between flicker light-induced arterial retinal vasodilation and the amplitude and implicit time of the N95 wave of pattern ERG (r = -0.27, P = 0.047 and r = -0.35, P = 0.008, respectively), the b-wave implicit time of rod ERG (r = -0.36; P = 0.01) and the oscillatory potentials (r = 0.4; P = 0.003), suggesting that impairment of the vascular response to flicker light may reflect inner retinal neural impairment. However, no correlation between these factors was found when only patients with diabetes were considered. CONCLUSIONS: In patients with diabetes, neural and neurovascular dysfunctions both precede the onset of clinically detectable DR. To which extent these abnormalities are related to each other remains to be determined. (ClinicalTrials.gov number, NCT00839150.)

Spontaneous resolution of macular edema after panretinal photocoagulation in florid proliferative diabetic retinopathy.

PURPOSE: To report the evolution of diabetic macular edema (DME) after extensive panretinal photocoagulation in patients with Type 1 diabetes exhibiting florid proliferative diabetic retinopathy (FPDR). METHODS: This retrospective observational case series comprised 17 eyes of 10 consecutive patients (8 women and 2 men). All patients exhibited FPDR combined with severe DME, and all underwent panretinal photocoagulation. The evolution of visual acuity and progression of FPDR were evaluated. The evolution of DME during follow-up was assessed by fluorescein angiography and repeated optical coherence tomography examinations. RESULTS: At baseline, all eyes had diffuse DME. Mean logMAR visual acuity was 0.402 +/- 0.46. Mean central macular thickness was 468.23 +/- 113.63 microm. After panretinal photocoagulation, DME regressed spontaneously in all eyes after a mean follow-up of 7.1 +/- 2.68 months. Mean central macular thickness decreased to 268.12 +/-54.67 microm (t-test, P < 0.0001). Mean visual acuity improved significantly to 0.184 +/- 0.12 (t-test, P = 0.048). Diabetic macular edema only recurred in two eyes. CONCLUSION: In DME combined with FPDR, extensive panretinal photocoagulation and glycemic control seem effective in reducing DME and improving vision. In FPDR, DME may be caused by excessive production of vascular endothelial growth factor by the unperfused retina.

Dome-shaped macula in eyes with myopic posterior staphyloma.

PURPOSE: To describe an unusual feature in myopic eyes responsible for visual loss, which we call a dome-shaped macula. DESIGN: Retrospective, observational case series. METHODS: After observing isolated cases of dome-shaped macula, we analyzed optical coherence tomography (OCT) scans of 140 highly myopic eyes present in our OCT database to find similar cases. Fifteen eyes of 10 patients had a dome-shaped macula. These patients all had undergone fluorescein angiography (FA), indocyanine green angiography (ICGA), and B-scan ultrasonography examinations. RESULTS: The mean refractive error of the affected eyes was -8.25 diopters (D; range, -2 to -15 D). Median visual acuity was 20/50. Recent visual impairment was noted in 11 of the 15 eyes studied, and metamorphopsia was noted in eight eyes. Four eyes were asymptomatic. FA showed atrophic changes in the macular retinal pigment epithelium (RPE) in all eyes, combined with focal points of leakage in seven of the 15 eyes. The dome-shaped appearance of the macula was visible on both B-scan ultrasonography and OCT: a characteristic bulge of the macular retina, RPE, and choroid within the concavity of the moderate posterior staphyloma was present in all eyes. In 10 eyes, OCT also showed a shallow foveal detachment at the top of the dome-shaped macula. CONCLUSIONS: A dome-shaped macula within a myopic staphyloma is an unreported type of myopic posterior staphyloma. The dome-shaped macula often is associated with RPE atrophic changes and foveal retinal detachment, which may explain the visual impairment in these eyes.

Full-thickness macular hole in a patient with diabetic cystoid macular oedema treated by intravitreal triamcinolone injections.

PURPOSE: Full-thickness macular hole associated with diabetic macular oedema is a rare feature and its pathogenesis remains incompletely elucidated. We report the occurrence of a full-thickness macular hole, documented with optical coherence tomography (OCT), in a patient with diabetic cystoid macular oedema treated by intravitreal triamcinolone injections. CASE REPORT: A 48-year-old woman with refractory diabetic cystoid macular oedema underwent successive intravitreal triamcinolone injections, which were followed by a progressive thinning of the neurosensory retina at the fovea, and then by a full-thickness macular hole, associated with a perifoveal posterior hyaloid detachment, visible on OCT. During pars plana vitrectomy, a thin epiretinal macular membrane was diagnosed and removed. DISCUSSION: Pathogenesis of the present full-thickness macular hole associated with diabetic macular oedema is different from that of idiopathic macular holes because anteroposterior vitreous tractions were not involved in its formation. Recurrent intravitreal triamcinolone injections may have had an indirect role in the development of the macular hole, by favouring the rupture of distended Muller cells and intraretinal pseudocysts.

Intravitreal triamcinolone acetonide for diffuse diabetic macular edema: phase 2 trial comparing 4 mg vs 2 mg.

PURPOSE: To prospectively compare the efficacy and safety of 4 vs 2 mg intravitreal triamcinolone acetonide (TA) injection for diabetic macular edema. DESIGN: Interventional case series. PATIENTS: Thirty-two patients with diabetic macular edema unresponsive to laser photocoagulation. INTERVENTION: Patients were randomly assigned to receive 4 or 2 mg intravitreal TA in one eye (16 patients in each group). MAIN OUTCOME MEASURES: The main outcome was central macular thickness (CMT) measured by optical coherence tomography (OCT) at four, 12, and 24 weeks. Secondary outcomes were gain in Early Treatment Diabetic Retinopathy Study (ETDRS) scores, intraocular pressure (IOP), cataract progression, and duration of effect. RESULTS: Before injection, mean (+/- SD) CMT was 564.5 +/- 119 microm and 522.9 +/- 148.5 microm in the 4- and 2-mg groups, respectively. At four, 12, and 24 weeks after injection, it was 275.0 +/- 79.8, 271.4 +/- 128.7, and 448.7 +/- 146.4 microm, respectively, in the 4-mg group, and 267.3 +/- 82.4, 289.8 +/- 111.4, and 394.7 +/- 178.9 microm, respectively, in the 2-mg group. At no time was the difference in CMT between both groups statistically significant (P> 0.3). The between-group differences in the gain in the ETDRS score and in IOP were not statistically significant either. Diabetic macular edema recurred after a median period of 20 weeks vs 16 weeks in the 4- and 2-mg groups, respectively (P = 0.11). CONCLUSIONS: In the short term, intravitreal injection of 4 or 2 mg TA does not have different effects on CMT, visual acuity, or IOP.

Evaluation of macular changes before and after successful retinal detachment surgery using stratus-optical coherence tomography.

PURPOSE: To assess preoperative and postoperative infra-clinical macular changes in macula-off retinal detachment (RD) using third-generation optical coherence tomography (OCT3). DESIGN: Prospective observational cohort study. METHODS: Twenty-two nonconsecutive eyes of 22 patients with macula-off RD underwent best-corrected visual acuity measurement and OCT3 scans through the fovea before and after successful surgery. The relationship between preoperative and postoperative OCT macular characteristics, postoperative infra-clinical foveal detachment, and final visual acuity (FVA) were assessed using Kruskal-Wallis multiple comparison test and Mann-Whitney U test, respectively. RESULTS: Preoperative cystic cavities in the inner nuclear layer of the detached retina, postoperative abnormal macular profile, and postoperative lack of the junction line between photoreceptor cell inner and outer segments on OCT3 were associated with a poorer FVA (P = .001, P = 10(-4) and P = .015, respectively). In contrast, postoperative infra-clinical foveal detachment did not influence FVA (P = .88). CONCLUSIONS: Morphologic macular analysis using OCT3 provide some new insights to understand incomplete visual recovery after successful macula-off RD surgery.

Predictive visual outcome after macula-off retinal detachment surgery using optical coherence tomography.

PURPOSE: To determine whether preoperative optical coherence tomography (OCT) is useful in predicting postoperative visual outcome for patients with primary macula-off rhegmatogenous retinal detachment (RD). METHODS: This prospective study included 20 nonconsecutive eyes with macula-off RD and successful reattachment of the retina. Preoperative 5-mm OCT was performed through the center of the fovea. The relationship among preoperative OCT findings, main preoperative clinical variables, and final postoperative visual acuity was statistically analyzed. RESULTS: Final postoperative visual acuity was negatively correlated with three preoperative OCT variables: height of RD at the central fovea (r=0.79; P <0.001), distance from the central fovea to the nearest undetached retina (r=0.75; P <0.00051), and, to a lesser degree, extent of structural changes in the detached retina (r=0.48; P=0.03). Preoperative visual acuity was the only clinical variable statistically correlated with final postoperative visual acuity in this study (r=0.55; P=0.01). Using multivariate logistic regression analyses, the structure of the detached retina combined with the distance from the central fovea to the nearest undetached retina, as determined with OCT, was highly correlated with final postoperative visual acuity (r=0.82; P <0.000051). CONCLUSION: Preoperative macular analysis with OCT may help to predict visual outcome for patients with macula-off RD.