Mecobalamin Combined With Anti-VEGF Intravitreal Injection for Treatment Retinal Vein Occlusion: a Double-blind Randomized Controlled Trial
Retinal vein occlusion (RVO), a common retinal vascular disease, is frequently treated with anti-vascular endothelial growth factor (anti-VEGF) agents as first-line therapy. However, anti-VEGF monotherapy lacks neuroprotective effects, primarily targets vascular leakage and neovascularization, and requires frequent long-term injections that impose substantial economic burdens. Combined therapeutic strategies addressing both vascular pathology and neural damage are therefore being explored. This article describes the protocol for a randomized, outcome-blinded, placebo-controlled clinical trial evaluating mecobalamin (a widely used neuroprotective drug) in combination with anti-VEGF for the treatment of macular edema (ME). A total of 120 eligible RVO patients will be enrolled from the First Affiliated Hospital of Chongqing Medical University. Participants will be randomly assigned (1:1) to an experimental group and a control group. The experimental group will receive conventional anti-VEGF therapy plus oral mecobalamin capsules for 6 months, while the control group will receive the same anti-VEGF treatment plus a placebo for 6 months. All patients will undergo one year of follow-up after initial treatment, with visits at 1, 3, 6, 9, and 12 months. The primary outcome is the change in central subfield thickness (CST) from baseline to one year post-initial treatment. Secondary outcomes include: * Change in best-corrected visual acuity (BCVA) from baseline over time, * Capillary density, * Cone photoreceptor distribution characteristics, * Mean light sensitivity and fixation stability, * Serum vitamin B12 levels, * Number of anti-VEGF treatments, * Injection frequency (times per year), * Treatment interval, * Incidence and severity of adverse events (AEs) and serious adverse events (SAEs). This trial evaluates a novel neuroprotection + vascular intervention strategy combining mecobalamin with anti-VEGF therapy. The trial aims to provide high-level evidence for synergistic RVO treatment, with the potential to reduce recurrence rates and improve long-term visual function prognosis.
• Diagnosis of RVO meeting the international diagnostic criteria 4,12, age 18-80 years, gender not limited Treatment-naive RVO-ME (no prior anti-VEGF, glucocorticoid, or laser therapy) The CST is confirmed to be ≥300μm by OCT The baseline BCVA (ETDRS letter count) was 20/400 to 20/40 (34-78 letters) Signed informed consent and ability to comply with follow-up.