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

March 11, 2024 updated by: Shanghai Eye Disease Prevention and Treatment Center

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

58

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 201103
        • Recruiting
        • Shanghai Eye Diseases Prevention &Treatment Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
improvement of visual acuity
Time Frame: from baseline to 12 months after initial intravitreal Conbercept injection
mean change in best corrected visual acuity letter score
from baseline to 12 months after initial intravitreal Conbercept injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Eye Disease Prevention and Treatment Center

Collaborators

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

  • Study Chair: Tao Sun, Shanghai Eye Diseases Prevention & Treatment Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

March 4, 2024

First Submitted That Met QC Criteria

March 4, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YFZXYDK202402

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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