Efficacy and Safety of Conbercept for Diabetic Macular Edema Combined With Severe Non-proliferative Diabetic Retinopathy - Trial NCT06305143
Access comprehensive clinical trial information for NCT06305143 through Pure Global AI's free database. This Phase 4 trial is sponsored by Shanghai Eye Disease Prevention and Treatment Center and is currently Recruiting. The study focuses on Diabetic Macular Edema. Target enrollment is 58 participants.
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Study Focus
Sponsor & Location
Shanghai Eye Disease Prevention and Treatment Center
Timeline & Enrollment
Phase 4
Apr 01, 2024
Jul 01, 2025
Primary Outcome
improvement of visual acuity
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
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06305143
Non-Device Trial