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Mecobalamin Combined With Anti-VEGF Intravitreal Injection for Retinal Vein Occlusion Treatment

NCT07133438 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-02-27

No results posted yet for this study

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.

Conditions

  • Retinal Vein Occlusion (RVO)

Interventions

DRUG

Anti-VEGF drug

conventional anti-VEGF therapy (intravitreal injections of conbercept 0.5 mg initially once a month for 3 months, followed by on-demand therapy which based on recurrence criteria)

DRUG

Mecobalamin 5 MG

oral mecobalamin capsules 0.5 mg three times daily for 6 months

DRUG

Placebo

placebo capsule with a similar appearance and odor to the mecobalamin capsules three times daily for 6 months

Sponsors & Collaborators

  • First Affiliated Hospital of Chongqing Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2027-05-31
Completion
2027-07-31

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07133438 on ClinicalTrials.gov