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Observational Study
. 2021 Jan 12;21(1):33.
doi: 10.1186/s12886-020-01757-7.

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

Raja Narayanan  1 , Aditya Kelkar  2 , Zahir Abbas  3 , Neha Goel  4 , Manoj Soman  5 , Naveen Naik  6 , Aditya Sudhalkar  7 , Jaydeep Walinjkar  8 , Utkarsh Shah  9 , Nitin Maksane  9
Affiliations
Observational Study

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

Raja Narayanan et al. BMC Ophthalmol. .

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 .

Keywords: Macular edema; Open label prospective study; Ranibizumab; Retinal vein occlusion; Visual acuity.

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Conflict of interest statement

Dr. Utkarsh Shah is a medical advisor and Dr. Nitin Maksane is a franchise medical head. Both are employees of Novartis Healthcare Private Limited, India. Dr. Raja Narayanan, Dr. Aditya Kelkar, Dr. Zahir Abbas, Dr. Neha Goel, Dr. Manoj Soman, Dr. Naveen Naik, Dr. Aditya Sudhalkar and Dr. Jaydeep Walinjkar were the investigators of the regulatory mandated phase 4 study undertaken by Novartis Healthcare Private Limited. Although the study was funded by Novartis Healthcare Private Limited, there was no interference with the independent analysis of the data. They do not have any competing interests.

Figures

Fig. 1
Fig. 1
Mean Number of Injections and Visual Acuity Gain. The maximum gain in vision from baseline occurred after the first injection and was sustained through week 48. However, the patients required further injections during the follow-up to maintain the gain in vision
Fig. 2
Fig. 2
Mean Change in Central Retinal Thickness Measured by Optical Coherence Tomography for the Selected Eye. After the initial 3 loading doses, there is a gradual worsening of macular edema between weeks 8 and 16, suggesting under-treatment during this period. n: Number of patients with available recordings of CRT
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