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Non-inferiority study of the efficacy of ranibizumab BS compared with aflibercept in patients with macular oedema due to untreated branch retinal vein occlusion: REMEDY-BRVO study – study protocol

Year: 2026

Type: article

Abstract: Introduction Although anti-vascular endothelial growth factor (VEGF) therapy is the standard treatment for branch retinal vein occlusion (BRVO), treatment costs, the number of required injections and concerns about systemic adverse effects remain challenges. The REMEDY-BRVO study aims to evaluate the efficacy of ranibizumab biosimilar (BS) in patients with macular oedema due to untreated BRVO and to determine whether ranibizumab BS is non-inferior to aflibercept.Methods and analysis This study is a randomised, open-label, multicentre, parallel-group comparative trial. A total of 140 patients aged 50 years or older with BRVO, central retinal thickness ≥300 µm, and best-corrected visual acuity (BCVA) of 20–70 Early Treatment Diabetic Retinopathy Study (ETDRS) letters within 6 months after BRVO onset will be enrolled. Participants will be randomly assigned to receive either ranibizumab BS or aflibercept using a single loading dose followed by pro re nata treatment over 24 weeks. The primary endpoint is the mean change in BCVA from baseline to week 24. Secondary endpoints include changes in central retinal thickness, the proportion of patients with visual acuity improvement, number of injections, quality of life assessed by the National Eye Institute Visual Function Questionnaire-25, incidence of ocular and systemic adverse events and changes in serum VEGF levels. The non-inferiority margin is set at 4.9 letters.Ethics and dissemination The study has been approved by the Juntendo University Certified Review Board (CRB3180012) and will be conducted in accordance with the Declaration of Helsinki. Patients and the public were not involved in the design of this study protocol. The results of this study will be disseminated through publication in peer-reviewed journals and presentations at domestic and international scientific conferences.Trial registration number jRCTs031240691.

Source: BMJ Open Ophthalmology

DOI: 10.1136/bmjophth-2026-002799