Outcomes after a 1-Year Treatment with Ranibizumab for Diabetic Macular Edema in a Clinical Setting.

PURPOSE: The aim of this study was to assess the efficacy and safety of ranibizumab in patients with diabetic macular edema (DME). METHODS: We conducted a retrospective analysis of consecutive patients with vision loss due to DME who were treated with ranibizumab. All patients received a loading dose of 3 monthly injections followed by re-treatments on an as-needed basis. The primary endpoint was the change in best-corrected visual acuity (BCVA) at 12 months. Secondary endpoints were the change in central retinal thickness (CRT) and the number of intravitreal injections (IVI) at 12 months. RESULTS: One hundred and six eyes of 78 patients were included. BCVA changed from 48.3 (20/100) letters at baseline to 59.0 letters (20/63) at 12 months (p < 0.0001; mean gain: +10.7 letters), and 38% of the patients had a final BCVA >70 letters. CRT decreased from 519 µm at baseline to 355 µm at 12 months (p < 0.0001). The threshold of the first quartile of the baseline VA was 40 letters. Patients with a baseline VA >40 letters had a higher final VA of 66 ± 14 letters (20/50) versus 43 ± 18 letters (20/125) for patients with a baseline VA ≤40 letters (p < 0.0001). A mean number of 5.4 (3-10) IVI were administered. CONCLUSION: This study conducted in a clinical setting confirms the results of previous randomized trials. The final BCVA was mainly influenced by the baseline BCVA, which supports the utility of early DME treatment before patients experience a severe vision loss.

Inaugural severe vaso-occlusive retinopathy in systemic lupus erythematosus.

Purpose To report the case of a patient with an inaugural severe bilateral vaso-occlusive retinopathy due to systemic lupus erythematosus. Method Clinical examination, fundus pictures and fluorescein angiography were performed. Results A 26-year-old, healthy, African man presented with a meningo-encephalitic syndrome and a severe bilateral visual impairment. The fundus examination revealed multiple retinal vascular occlusions, and a fluorescein angiography showed retinal and choroidal ischemia bilaterally. In addition, based on the neurologic disorders, a pleuritis, a renal disorder and a hematologic disorder, systemic lupus erythematosus, was diagnosed. Conclusions Severe vaso-occlusive retinopathy in a 26-year-old man resulting in a significant visual loss as the initial manifestation of systemic lupus erythematosus. Central nervous system involvement during lupus might be more frequent in patients when serious retinal changes occur.

Randomized clinical trial France DMLA2: effect of trimetazidine on exudative and nonexudative age-relatedmacular degeneration.

PURPOSE: To evaluate the effect of trimetazidine (TMZ) in a randomized, double-blind, placebo-controlled clinical trial on the occurrence of choroidal neovascularization or geographic atrophy in age-related macular degeneration. METHODS: A total of 1,086 patients from France, Belgium, and Spain with soft drusen and/or retinal pigment epithelium abnormalities in the study eye and choroidal neovascularization in the contralateral eye were randomly assigned to receive orally placebo or TMZ 70 mg daily (35 mg × 2) and followed-up for 3 years to 5 years. RESULTS: Treatment duration ranged between 0.4 months and 67.8 months with a mean ± SD of 38 ± 16 months. Three hundred and fifty-eight patients developed choroidal neovascularization (incidence per 100 patient-years: TMZ 10.86; placebo 11.13). Trimetazidine did not prevent the choroidal neovascularization (hazard ratio = 0.97; 95% confidence interval, 0.77-1.20; P = 0.781). However, there was a trend favoring TMZ for retinal atrophy, a secondary endpoint (HR = 0.76; 95% confidence interval, 0.56-1.02; P = 0.069). Overall, the difference in atrophy incidence between TMZ and placebo was not statistically different. Differences within some prespecified subgroups of patients showed superiority of TMZ in men (HR = 0.50; 95% confidence interval, 0.28-0.89; p = 0.016), in patients aged ≤75 years (HR = 0.58; 95% confidence interval, 0.38-0.88; p = 0.010), or in patients presenting with isolated pigmentary changes (HR = 0.19; 95% confidence interval, 0.05-0.70; p = 0.005). CONCLUSION: Trimetazidine failed to prevent choroidal neovascularization. Subgroup analyses suggest that this drug could be tested as preventive therapy for geographic atrophy, although the overall comparison showed no statistically significant differences in the progression of geographic atrophy.

Functional and Anatomical Outcomes in Patients With Serous Retinal Detachment in Diabetic Macular Edema Treated With Ranibizumab.

Purpose: To assess the effect of serous retinal detachment (SRD) on functional and anatomical outcomes in ranibizumab-treated patients with diabetic macular edema (DME). Methods: All consecutive ranibizumab-treated patients with SRD were included in this retrospective study. For each patient with SRD, a patient without SRD with the same baseline best-corrected visual acuity (BCVA) was randomly included for adjustment on their baseline BCVA. All patients with SRD were included in group 1 (G1) and those without SRD in G2. The primary endpoint was the mean change in BCVA between baseline and month 12 (M12). Secondary endpoints were the mean change in central retinal thickness (CRT) between baseline and M12, injection number, and proportion of patients who gained/lost ≥15 letters. Results: Seventy-eight eyes were included, 39 in each group. Baseline BCVA was similar in both groups (45.2 and 45.3 letters). Mean change in BCVA between baseline and M12 was not statistically different: 11 ± 12 letters in G1 and 12 ± 13 letters in G2 (P = 0.78). Baseline CRT was 650 ± 130 µm in G1 and 480 ± 79 µm in G2. Mean change in CRT was -235 ± 170 µm in G1 and -130 ± 96 µm in G2 (P = 0.013). Patients received 5.2 and 5.5 injections in G1 and G2 (P = 0.46). In group 1, 38.5% and 2.6% of patients respectively gained and lost ≥15 letters versus 41% (P = 0.1) and 5.1% (P = 0.1) in G2. Conclusions: Similar BCVA gains were observed regardless of the presence of SRD. The higher visual gain usually observed in DME with SRD could be associated with a lower baseline BCVA.

Limbal stem cell deficiency following phototherapeutic keratectomy.

PURPOSE: To describe a case of limbal stem cell (LSC) deficiency following phototherapeutic keratectomy (PTK). METHODS: We analyzed the case of a 67-year-old man who developed LSC deficiency in his left eye following PTK for recurrent epithelial erosions. Predisposing factors included diabetes mellitus and rosacea. RESULTS: Surgical treatment consisted of debridement of the diseased corneal epithelium, followed by limbal autografting from the fellow eye. The cornea healed and remained transparent after 1 year. Histologic examination confirmed the diagnosis of LSC deficiency, showing the presence of goblet cells and inflammatory cells within the epithelium. CONCLUSION: The extensive corneal mechanical debridement and laser photoablation incurred during phototherapeutic keratectomy can cause clinical LSC deficiency in patients with predisposing external diseases.

Nutritional, lifestyle and environmental factors in ocular hypertension and primary open-angle glaucoma: an exploratory case-control study.

PURPOSE: To evaluate known and potential risk factors, including nutritional, lifestyle and environmental factors, differentiating patients with high-tension primary open-angle glaucoma (POAG) from control subjects with ocular hypertension (OHT). METHODS: In 2006-2007, 111 French ophthalmologists prospectively enrolled 339 cases of POAG and 339 age-matched controls with OHT. After a clinical examination with assessment of ocular risk factors, the ophthalmologist filled, during face-to-face interview, a detailed questionnaire developed by nutritionists and epidemiologist on lifestyle and environmental risk factors, including socio-demographic variables, dietary habits related to omega-3 fatty acids intake, smoking and alcohol drinking and professional exposure to pesticides and other chemicals. Associations of POAG with risk factors were estimated using conditional logistic regression, with adjustment for age, gender and duration of disease. RESULTS: In the final multivariate model, by comparison with OHT, POAG was significantly associated with more frequent use of pesticides during the professional life [OR = 2.65, 95% confidence interval (CI): 1.04-6.78, p = 0.04] and with low consumption of fatty fish (OR = 2.14, 95% CI: 1.10-4.17, p = 0.02) and walnuts (OR = 2.02, 95% CI: 1.18-3.47, p = 0.01). POAG was also associated with higher frequency of heavy smoking (40 pack-years or more, OR = 3.93, 95% CI: 1.12-13.80, p = 0.03) but not with moderate (20-40 pack-years) and light smoking (<20 pack-years). CONCLUSIONS: These exploratory observations suggest a protective effect of omega-3 fatty acids and a deleterious effect of heavy smoking and professional exposure to pesticides in POAG. This will need to be confirmed in future studies.

Takayasu disease revealed by bilateral loss of vision.

PURPOSE: Takayasu arteritis is a nonspecific granulomatous inflammatory arteriopathy of unknown cause, most frequently diagnosed in young Asian women. The authors present an atypical initial presentation of Takayasu disease with bilateral loss of vision in a young Haitian man. METHODS: Case report. RESULTS: The presenting feature was bilateral loss of vision, a result of malignant hypertensive retinopathy and choroidopathy. Systemic evaluation disclosed inflammatory signs and renal artery obstruction which caused the malignant hypertension. CONCLUSION: This case, involving an unusual presentation of Takayasu disease, illustrates how a malignant hypertensive retinopathy and choroidopathy led to the ultimate diagnosis of Takayasu disease.