Diabetic macular edema
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with type II diabetes aged >18 years; 2. Glycated hemoglobin (HbA1c) value <=10%; 3. There is no opacity of refractive medium and pupil reduction that affect fundus examination; 4. According to the 2019 AAO DR PPP diagnosis of macular edema involving the fovea (CI-DME), the thickness of the fovea measured by Heidelberg OCT is higher than the average normal +2SD (male 320um/female 305um), and it is determined that there is a clear DME.
Exclusion criteria
Exclusion criteria: (1) macular edema caused by other causes than diabetes; (2) cloudy ophthalmology due to cataract or other reasons; (3) retinal laser photocoagulation after receiving vitreoretinal surgery or retinal detachment within 3 months; (4) the target eye with proliferative diabetic retinopathy (PDR); (5) the target eye with vitreous hemorrhage within 2 months before screening; (6) the target eye with iris neovascularization; (7) Uncontrolled Hypertension or HbA1c> 12% poor glycemic control; (8) Cerebrovascular accident or MI within the last 3 months; (9) A history of anaphylaxis or allergy to sodium fluorescein, A history of allergy to protein preparations for treatment or diagnosis, allergy to two or more drugs and / or non-drug agents, or allergic diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| changes of intra-retinal layers;Zuì jia jiaozhèng shìlì 6/5000 Best corrected vision; | — |
Countries
China
Contacts
Shanghai Sixth People's Hospital