NCT07133438 Mecobalamin Combined With Anti-VEGF Intravitreal Injection for Retinal Vein Occlusion Treatment
| NCT ID | NCT07133438 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | First Affiliated Hospital of Chongqing Medical University |
| Condition | Retinal Vein Occlusion (RVO) |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 120 participants in total. It began in 2025-08-01 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07133438 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Retinal Vein Occlusion (RVO). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07133438 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07133438 currently recruiting?
Yes, NCT07133438 is actively recruiting participants. Contact the research team at dengwenli@hospital.cqmu.edu.cn for enrollment information.
Where is the NCT07133438 trial being conducted?
This trial is being conducted at Chongqing, China.
Who is sponsoring the NCT07133438 clinical trial?
NCT07133438 is sponsored by First Affiliated Hospital of Chongqing Medical University. The trial plans to enroll 120 participants.