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

NCT ID: NCT06305143

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-07-01

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

intravitreal Conbercept

Participants with diabetic macular edema (DME) combined with severe non-proliferative diabetes retinopathy (sNPDR) were assigned to anti-VEGF therapy over 12 months.

Group Type: EXPERIMENTAL

Conbercept

Intervention Type: DRUG

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

Interventions

Conbercept

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• symptomatic patients aged 18 years or above with center involved diabetic macular edema in the involved eye and without clinically significant diabetic macular edema in the fellow eye defined on the basis of spectral-domain optical coherence tomography (OCT)
• central macular thickness (CMT) ≥300 μm measured by OCT
• the involved eyes diagnosed as severe non-proliferative diabetic retinopathy (sNPDR) confirmed by two independent experienced ophthalmologists based on the ETDRS standard seven field color fundus photographs

Exclusion Criteria

• concomitant or previous macular diseases that may hinder visual improvement other than diabetic retinopathy (e.g., retinal vein occlusion, age-associated macular degeneration, uveitis, vitreomacular traction or epiretinal membrane)
• history of glaucoma or optic neuropathy of any kind
• previous vitreoretinal surgery or pan-retinal photocoagulation
• intravitreal injection anti-VEGF drugs within 6 months or intravitreal injection glucocorticoid within 3 months
• macular focal/grid laser photocoagulation within 3 months

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: collaborator

Shanghai Eye Disease Prevention and Treatment Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tao Sun

Role: STUDY_CHAIR

Shanghai Eye Diseases Prevention & Treatment Center

Locations

Shanghai Eye Diseases Prevention &Treatment Center

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

YFZXYDK202402

Identifier Type: -

Identifier Source: org_study_id