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

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
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.

Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v5
  2. Primary completion date: Dec 31, 2024 to Jun 1, 2025v4
  3. Re-verified, no change to tracked fieldsv3
  4. Eligibility criteria revisedv2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
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
(from sponsor)		 Diabetic Macular Edema
Enrollment 58 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov