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

Phase 4

Recruiting

• Conditions: Diabetic Macular Edema
• Interventions: Drug: Conbercept

• Registration Number: NCT06305143
• Lead Sponsor: Shanghai Eye Disease Prevention and Treatment Center

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-04
• Study First Submitted QC: 2024-03-04
• Study First Posted: 2024-03-12
• Study Start: 2024-04-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-22
• Last Update Posted: 2024-07-23
• Primary Completion: 2024-12-31
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 58

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
improvement of visual acuity	from baseline to 12 months after initial intravitreal Conbercept injection	mean change in best corrected visual acuity letter score

Trial Locations

Locations (1)

Shanghai Eye Diseases Prevention &Treatment Center; 🇨🇳 Shanghai, Shanghai, China