[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603201":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":36,"locations":42,"responsibleParty":60,"collaborators":27,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":27,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":27,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":45,"whyStopped":27,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"First Affiliated Hospital of Chongqing Medical University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"experimental group","EXPERIMENTAL","Patients in the experimental group will receive 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) along with oral mecobalamin capsules 0.5 mg three times daily for 6 months.",[13,14],"Drug: Anti-VEGF drug","Drug: Mecobalamin 5 MG",{"label":16,"type":17,"description":18,"interventionNames":19},"control group","PLACEBO_COMPARATOR","Patients in the control group will receive the same anti-VEGF treatment as the experimental group and will take a placebo capsule with a similar appearance and odor to the mecobalamin capsules three times daily for 6 months",[13,20],"Drug: Placebo",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"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)",[16,9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Mecobalamin 5 MG","oral mecobalamin capsules 0.5 mg three times daily for 6 months",[9],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Placebo","placebo capsule with a similar appearance and odor to the mecobalamin capsules three times daily for 6 months",[16],[37],{"name":38,"role":39,"phone":40,"phoneExt":27,"email":41},"Wen-Li Deng, doctoral","CONTACT","+8619823579019","dengwenli@hospital.cqmu.edu.cn",[43],{"facility":44,"status":45,"city":46,"state":27,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"No. 1, Friendship Road, Yuanjiagang, Yuzhong District, Chongqing City","RECRUITING","Chongqing","400016","China","CN",{"type":51,"coordinates":52},"Point",[53,54],106.55771,29.56026,{"lat":54,"lon":53},[57],{"name":58,"role":39,"phone":59,"phoneExt":27,"email":41},"Wen-Li Deng Dr, PhD, MD","19823579019",{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"PRINCIPAL_INVESTIGATOR","Yan-Lai Zhang","associate chief physician","100603201","phase-4-mecobalamin-combined-with-anti-vegf-intravitreal-injection-for-retinal-vein-occlusion-treatment-100603201",false,"NCT07133438","Mecobalamin Combined With Anti-VEGF Intravitreal Injection for Retinal Vein Occlusion Treatment","Mecobalamin Combined With Anti-VEGF Intravitreal Injection for Treatment Retinal Vein Occlusion: a Double-blind Randomized Controlled Trial","Inclusion Criteria:\n\nDiagnosis 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\u002F400 to 20\u002F40 (34-78 letters) Signed informed consent and ability to comply with follow-up.\n\nExclusion Criteria:\n\nCombined 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\u002Frenal 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","ALL","18 Years","80 Years",{"count":75,"type":76},120,"ESTIMATED","INTERVENTIONAL",[79],"PHASE4","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.\n\nThis 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.\n\nThe primary outcome is the change in central subfield thickness (CST) from baseline to one year post-initial treatment. Secondary outcomes include:\n\n* Change in best-corrected visual acuity (BCVA) from baseline over time,\n* Capillary density,\n* Cone photoreceptor distribution characteristics,\n* Mean light sensitivity and fixation stability,\n* Serum vitamin B12 levels,\n* Number of anti-VEGF treatments,\n* Injection frequency (times per year),\n* Treatment interval,\n* Incidence and severity of adverse events (AEs) and serious adverse events (SAEs).\n\nThis 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.",[82],"Retinal Vein Occlusion (RVO)",[82,84,85],"Macular edema","Anti-VEGF","2026-02-24",{"date":88,"type":89},"2026-02-27","ACTUAL",{"date":91,"type":89},"2025-08-01",{"date":93,"type":76},"2027-07-31",{"name":5,"class":6},1]