Mecobalamin plus anti-VEGF injections for retinal vein occlusion with macular edema
Mecobalamin Combined With Anti-VEGF Intravitreal Injection for Treatment Retinal Vein Occlusion: a Double-blind Randomized Controlled Trial
This will test whether adding mecobalamin to standard anti-VEGF eye injections helps people with retinal vein occlusion and macular edema improve vision and reduce retinal swelling.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital of Chongqing Medical University Academic / other |
| Locations | 1 site (Chongqing) |
| Trial ID | NCT07133438 on ClinicalTrials.gov |
What this trial studies
This is a randomized, outcome‑blinded, placebo‑controlled Phase 4 trial enrolling 120 treatment‑naive RVO patients at the First Affiliated Hospital of Chongqing Medical University. Participants are randomized 1:1 to receive standard anti‑VEGF intravitreal injections with either mecobalamin or placebo. Key outcomes include changes in best‑corrected visual acuity and retinal thickness measured by OCT, with scheduled follow‑up visits to monitor response and safety. The trial targets both vascular leakage and neural protection by combining anti‑VEGF therapy with a neurotrophic agent.
Who should consider this trial
Good fit: Adults aged 18–80 with treatment‑naive retinal vein occlusion causing macular edema, baseline BCVA between 20/400 and 20/40 (34–78 ETDRS letters), and central subfield thickness ≥300 μm on OCT who can provide informed consent and attend follow‑up are eligible.
Not a fit: People with other causes of macular edema (e.g., diabetic retinopathy or uveitis), prior anti‑VEGF/steroid/laser therapy, uncontrolled systemic disease, pregnancy or lactation, or inability to comply with visits are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If effective, the combination could improve visual recovery, better protect retinal neurons, and potentially reduce the need for frequent anti‑VEGF injections.
How similar studies have performed: Anti‑VEGF therapy is well established for RVO‑ME, but using mecobalamin as an added neuroprotective agent is novel and lacks large randomized proof of benefit to date.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. Exclusion Criteria: Combined with other eye diseases that cause ME (such as diabetic retinopathy, uveitis) Media opacities affecting imaging (such as severe cataract, vitreous hemorrhage) Prior anti-VEGF, steroid, or macular laser therapy Systemic use of glucocorticoids or immunosuppressants within 3 months Uncontrolled systemic disease (hypertension, diabetes, hepatic/renal dysfunction); pregnant or lactating women Allergy to mecobalamin or conbercept Unable to cooperate with examinations or follow-up, or participate in other clinical trials within one year
Where this trial is running
Chongqing
- No. 1, Friendship Road, Yuanjiagang, Yuzhong District, Chongqing City — Chongqing, China (Recruiting)
Study contacts
- Study coordinator: Wen-Li Deng, doctoral
- Email: dengwenli@hospital.cqmu.edu.cn
- Phone: +8619823579019
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.