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

NCT06305143 | Active Not Recruiting Phase 4

• 1 other identifier: YFZXYDK202402
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• improvement of visual acuity

  mean change in best corrected visual acuity letter score

  from baseline to 12 months after initial intravitreal Conbercept injection

Study Arms (1)

intravitreal Conbercept

EXPERIMENTAL

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

Drug: Conbercept

Interventions

Conbercept DRUG

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

intravitreal Conbercept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Eye Disease Prevention and Treatment Center: lead
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator

Study Sites (1)

Shanghai Eye Diseases Prevention &Treatment Center

Shanghai, Shanghai Municipality, 201103, China

Location

MeSH Terms

Interventions

KH902 fusion protein

Study Officials

• Tao Sun

  Shanghai Eye Diseases Prevention & Treatment Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 12, 2024
• Study Start: April 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)