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

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) .

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.