Abstract
BackgroundMacular edema secondary to retinal vein occlusion (RVO) is an important cause of loss of vision. Intravitreal injections (IVI) of anti-vascular endothelial growth factor (VEGF) are the standard of care in this disease, as shown in numerous randomized controlled trials. The purpose of this study was to study the efficacy and safety of ranibizumab, an anti-VEGF agent, in the real-world setting.MethodsThis was 48 weeks, open-label, prospective, multicentre, observational study. Patients diagnosed with ME secondary to RVO were treated with IVI of Ranibizumab 0.5 mg in real-world conditions. Efficacy was measured by improvement seen in best-corrected visual acuity (BCVA) in terms of Early Treatment of Diabetic Retinopathy Study (ETDRS) Letter Scores and change in central retinal thickness (CRT) measured by optical coherence tomography.ResultsOne hundred eyes of 100 patients (79 with branch retinal vein occlusion and 21 with central retinal vein occlusion) were recruited in the study. The mean (standard deviation, SD) BCVA was 52.8 (21.99) letters at baseline and 62.3 (24.40) letters at week 48. From baseline, there was a significant improvement in BCVA by 7.7 letters (p = 0.001) at 48 weeks. The mean (SD) of CRT was 479.9 (216.25) μm at baseline and it decreased significantly to 284.9 (171.35) μm at week 48 (p < 0.001). During the study period, the average number of intravitreal injections was 3.5 per patient. There was no report of endophthalmitis in any eye.ConclusionsRanibizumab is well tolerated and effective in treating macular edema secondary to RVO in real-world clinical settings. However, there is under-treatment compared to controlled clinical trials, and the gain in vision is sub-optimal with under-treatment.Trial registrationClinical Trials Registry - India: CTRI/2015/07/005985.
Highlights
Macular edema secondary to retinal vein occlusion (RVO) is an important cause of loss of vision
Intravitreal injection of 0.5 mg ranibizumab was administered to patients with macular edema (ME) secondary to RVO
Out of the 100 patients, 56 patients had less than 6 months, and 83 patients had less than 9 months of onset of the disease
Summary
Macular edema secondary to retinal vein occlusion (RVO) is an important cause of loss of vision. Intravitreal injections (IVI) of anti-vascular endothelial growth factor (VEGF) are the standard of care in this disease, as shown in numerous randomized controlled trials. Retinal vein occlusion (RVO) is the second most common retinal vascular disease which can lead to loss of vision [1]. It is commonly of 2 types: central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO) [2]. Excessive angiogenic growth factors such as vascular endothelial cell growth factor (VEGF) caused by hypoxia secondary to RVO, leads to vascular leakage and macular edema (ME). BRVO was found to be approximately seven times more common than CRVO [5]
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