Sub-optimal gain in vision in retinal vein occlusion due to under-treatment in the real world: results from an open-label prospective study of Intravitreal Ranibizumab

Abstract

Background 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. The purpose of this study was to study the efficacy and safety of ranibizumab, an anti-VEGF agent, in the real-world setting. Methods This 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. Results One 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. Conclusions Ranibizumab 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 registration Clinical Trials Registry - India: CTRI/2015/07/005985.

Comparison of Innovator vs. Biosimilar Ranibizumab in Treating Diabetic Macular Edema: A Multicenter Retrospective Study

“…Additionally, patients' lower educational status also means that they fail to perceive the benefits of treatment and are often unsatisfied with visual outcomes [6]. These factors mean that the majority of physicians in the developing world, including India, are forced to adopt a PRN treatment protocol from baseline, as evidenced by a lot of studies published from the region [10,12,16]. Previous studies from the west have also shown that about a third of the patients can do well even without the loading dose, provided a close follow-up can be maintained and reinjections given at the first instance of requirement based on established retreatment criteria [17].…”

Biosimilar versus InnovAtor MoLecule of RAnibizumab in Neovascular Age-Related MaCular DEgeneration (The BALANCE Trial): Real-World Evidence

“…While a fixed or a treat-and-extend regimen can result in better anatomical and morphological improvement than a PRN regimen for the treatment of nAMD, 32 in resource-poor settings a PRN regimen with strict follow-up can provide comparable results with much reduced expenses. 20 , 33 A further reduction in the expenses can be brought about with the use of biosimilar ranibizumab. 20 In real-life situations the burden of repeated injections may make it difficult to sustain treatments with biologics for long periods of time, more so with the higher cost of the innovator drug.…”

Long-term real-world outcomes in retinal vein occlusions: How close are we to the trials?

“…Sub-optimal visual gain may be due to undertreatment in real-world setting. [ 26 ] Presently, there is insufficient evidence on efficacy and cost-effectiveness of anti-VEGF in ischemic CRVO. [ 27 ]…”