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NCT06305143

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

The Efficacy and Safety of Conbercept for Diabetic Macular Edema Combined With Severe Non-proliferative Diabetic Retinopathy: 12-month Results From a Prospective Multicenter Open Label Study
Shanghai Eye Disease Prevention and Treatment Center·Phase 4·ClinicalTrials.gov·drugRecruiting
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Study focus
Disease/Condition
Diabetic Macular Edema
Drug/Device/Intervention
Conbercept
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Shanghai Eye Disease Prevention and Treatment Center
Location
Shanghai, China
Timeline & enrollment
Phase
Phase 4
Start date
Apr 01, 2024
End date
Jul 01, 2025
Enrollment
58 participants
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
Diabetic retinopathyOther specified diabetes mellitus with ophthalmic complicationsUnspecified diabetes mellitus with ophthalmic complicationsDiabetic cataractType 2 diabetes mellitus with ophthalmic complications
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06305143
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.