Clinical Trial

Efficacy and Safety of Conbercept for Diabetic Macular Edema Combined With Severe Non-proliferative Diabetic Retinopathy

Active, Not Recruiting Phase 4

Record status

This record was last updated May 30, 2025 (before its estimated June 1, 2025 completion). Its status may not reflect the trial's current state.

Summary

The goal of this prospective multicenter open label study is to evaluate the efficacy and safety of intravitreal injection Conbercept (IVC) for the treatment of diabetic macular edema (DME) combined with severe nonproliferative diabetes retinopathy (sNPDR). The main questions it aims to answer are: * mean changes in best corrected visual acuity (BCVA) and central macular thickness (CMT) in comparison with baseline at 12 months after initial treatment * proportion of eyes with visual gain ≥15 letters in Early Treatment Diabetic Retinopathy Study (ETDRS) chart and ≥2-step improvement in Diabetic Retinopathy Severity Scale (DRSS) score after 12 months of the treatment * proportion of eyes actually underwent PRP treatment after 3 and 12 months of the treatment * mean changes in BCVA and CMT from baseline to monthly follow-up time point * complications and adverse effects

Protocol Amendment History 4 amendments

This ClinicalTrials.gov record has been amended 4 times since 2024-03-04; most recent amendment 2025-05-25.

Status change: Recruiting → Active, Not Recruiting 2025-05-25

Trial Details

NCT Number	NCT06305143
Lead Sponsor	Shanghai Eye Disease Prevention and Treatment Center Collaborators: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Conditions	Diabetic Macular Edema
Enrollment	58 participants
Start Date	2024-04-01
Primary Completion	2025-06-01 (estimated)
Study Completion	2025-07-01 (estimated)
Updated on ClinicalTrials.gov	2025-05-30