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

Last updated: April 19, 2025
Sponsor: Shanghai Eye Disease Prevention and Treatment Center
Overall Status: Active - Recruiting

Phase

4

Condition

Diabetic Macular Edema

Diabetic Retinopathy

Macular Edema

Treatment

Conbercept

Clinical Study ID

NCT06305143
YFZXYDK202402
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • symptomatic patients aged 18 years or above with center involved diabetic macularedema in the involved eye and without clinically significant diabetic macular edemain the fellow eye defined on the basis of spectral-domain optical coherencetomography (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 ETDRSstandard seven field color fundus photographs

Exclusion

Exclusion Criteria:

  • concomitant or previous macular diseases that may hinder visual improvement otherthan diabetic retinopathy (e.g., retinal vein occlusion, age-associated maculardegeneration, 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 injectionglucocorticoid within 3 months

  • macular focal/grid laser photocoagulation within 3 months

Study Design

Total Participants: 58
Treatment Group(s): 1
Primary Treatment: Conbercept
Phase: 4
Study Start date:
April 01, 2024
Estimated Completion Date:
July 01, 2025

Connect with a study center

  • Shanghai Eye Diseases Prevention &Treatment Center

    Shanghai, Shanghai 201103
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.