Safety and Efficacy Study of Conbercept in Diabetic Macular Edema (DME) (Sailing)

• Status: Unknown status
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

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) .

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chengdu Kanghong Biotech Co., Ltd.; Chengdu Kanghong Biotech Co.,Ltd.

Criteria

Inclusion Criteria:

1. Patients sign informed consent, and are willing and able to comply with all the follow-ups;

2. Age ≥ 18 years , both genders;

3. Diagnosis of type 1 or type 2 diabetes mellitus;

4. Serum HbA1c ≤ 10%;

5. 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.

6. Non-study eye BCVA ≥ 24 letters (equivalent to Snellen visual acuity 20/320).

Exclusion Criteria:

1. Active infectious ocular inflammation in either eye;

2. Proliferative diabetic retinopathy (PDR) in the study eye, with the exception of inactive, regressed PDR;

3. Any other ocular disorder in the study eye that may cause macular edema excluded the diabetic retinopathy;

4. Iris neovascularization in the study eye;

5. Uncontrolled glaucoma, or history of glaucoma surgery;

6. Aphakia in the study eye;

7. History of vitrectomy in the study eye;

8. 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;

9. Liver, kidney dysfunction;

10. History of allergic reaction to fluorescein, protein agents for diagnosis or therapy, or more than 2 drug or nondrug factors, or concomitant allergic diseases.