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

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Shanghai Eye Disease Prevention and Treatment Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	Conbercept	participants with diabetic macular edema (DME) combined with severe non-proliferative diabetes retinopathy (sNPDR) were assigned to anti-VEGF therapy over 12 months.

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-06-01
• Completion: 2025-07-01
• First posted: 2024-03-12
• Last updated: 2025-05-30

Locations

1 site across 1 country: China