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

Date de début de l'étude : 1 juillet 2014

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.