Status:
UNKNOWN
Safety and Efficacy Study of Conbercept in Diabetic Macular Edema (DME) (Sailing)
Lead Sponsor:
Chengdu Kanghong Biotech Co., Ltd.
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study is designed to assess safety and efficacy of intravitreal injection of Conbercept on visual acuity and anatomic outcomes in patients with diabetic macular edema (DME) .
Eligibility Criteria
Inclusion
- Patients sign informed consent, and are willing and able to comply with all the follow-ups;
- Age ≥ 18 years , both genders;
- Diagnosis of type 1 or type 2 diabetes mellitus;
- Serum HbA1c ≤ 10%;
- Study eye must meet the following criteria:
- Visual acuity impairment caused by DME with involving foveal;
- BCVA score ≥ 24 and ≤ 73 Early Treatment Diabetic Retinopathy Study (ETDRS) letters at 4 meter/1 meter of ETDRS test(Equivalent Snellen chart 20/40 to 20/320);
- Visual impairment due to Choroidal Neovascularization (CNV) secondary to high myopia.
- Central retinal thickness (CRT) ≥300μm (spectral domain Optical Coherence Tomography (OCT), the CRT measurements must be confirmed by central reading center);
- Refractive media opacities and miosis have no effect on the fundus examination.
- Non-study eye BCVA ≥ 24 letters (equivalent to Snellen visual acuity 20/320).
Exclusion
- Active infectious ocular inflammation in either eye;
- Proliferative diabetic retinopathy (PDR) in the study eye, with the exception of inactive, regressed PDR;
- Any other ocular disorder in the study eye that may cause macular edema excluded the diabetic retinopathy;
- Iris neovascularization in the study eye;
- Uncontrolled glaucoma, or history of glaucoma surgery;
- Aphakia in the study eye;
- History of vitrectomy in the study eye;
- History of panretinal laser photocoagulation (PRP) in the study eye 6 months prior to the screening, or possibly need panretinal photocoagulation of the study eye during the study;
- Liver, kidney dysfunction;
- History of allergic reaction to fluorescein, protein agents for diagnosis or therapy, or more than 2 drug or nondrug factors, or concomitant allergic diseases.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2017
Estimated Enrollment :
248 Patients enrolled
Trial Details
Trial ID
NCT02194634
Start Date
July 1 2014
End Date
September 1 2017
Last Update
January 6 2016
Active Locations (17)
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1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
2
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100083
3
Beijing Tongren hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, China, 100730
4
Southwest Hospital
Chongqing, Chongqing Municipality, China, 400038