Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT06305143
NCT06305143Active, not recruitingPhase 4

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

Shanghai Eye Disease Prevention and Treatment Center1 site in 1 country58 target enrollmentStarted: April 1, 2024Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Active, not recruiting
Enrollment
58
Locations
1
Primary Endpoint
improvement of visual acuity
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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.

Intervention: Conbercept (Drug)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Completed
Phase 3
A Study To Evaluate The Safety And Efficacy Of An Investigational Diabetes Drug In Poorly Controlled Type II DiabeticsDiabetes Mellitus, Type 2
NCT00067951GlaxoSmithKline190
Completed
Phase 3
A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)Multiple Sclerosis, Relapsing-Remitting
NCT02861014Hoffmann-La Roche681
Completed
Phase 3
Magnevist® Injection Enhanced MRA Compared to Non Contrast MRA for the Detection of Structural Abnormalities of the Aortic Arch and Cerebral BranchesCardiovascular Abnormalities
NCT00310609Bayer123
Completed
Phase 3
Magnevist® Injection Enhanced MRA Compared to Non Contrast MRA for the Detection of Stenosis in the Calf and/or Pedal ArteriesStenosis
NCT00309075Bayer126
Completed
Phase 3
Magnevist® Injection-enhanced MRA Compared to Non Contrast MRA for the Detection of Stenosis of the Renal ArteriesRenal Artery Stenosis
NCT00310557Bayer116