Diabetic retinopathy
Conditions
Interventions
Anti-VEGF combined with dexamethasone intravitreal implant treatment :Patient is treated by intravitreal injection of aflibercept and dexamethasone implant (Zhuo Chuming ) with one week at baseline. T
Anti-VEGF therapy alone :Patient is treated by intravitreal injection of aflibercept (Zhuo Chuming ) according to 3+PRN protocol until month 6.
Sponsors
Eye Hospital, Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Age >= 40 years old, gender is not limited; (2) Type 1 or type 2 diabetes mellitus, blood sugar good control, glycosylated hemoglobin = 300µm; (6) hyper-inflammatory biomarkers (SRD, and/or HRD within 500 µm from the fovea, and/or hard exudation within 500 µm from the fovea) on OCT; (7) There is no refractive interstitial opacity and miosis that affect fundus examination; (8) The study eye has not undergone anti-VEGF drugs, glucocorticoid intraocular injection therapy, or macular laser treatment in the study eye; (9) The patient had good cooperation and compliance, and was willing to adhere to the follow-up time >= 6 months or even 12 months; (10) If both eyes meet the above conditions at the same time, the eye with poor visual acuity is selected as the study eye; (11) Voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) the presence of active proliferative diabetic retinopathy or iris neovascularization in the study eye; (2) The study eye had undergone panretinal photocoagulation therapy within the past 3 months; (3) diabetic optic neuropathy in the study eye; (4) macular degeneration with other macular depositions that affect visual acuity assessment and prognosis, such as epimacular membrane, macular hole, macular traction, macular fibrosis or scarring, dense hard exudation, etc., or macular edema caused by other reasons, such as uveitis, central retinal vein occlusion, etc.; (5) Previous intraocular injection therapy such as anti-VEGF drugs or glucocorticoids in the study eye; (6) Previous vitreoretinal surgery in the study eye; (7) History of glaucoma or ocular hypertension that is not controlled by drugs (intraocular pressure is still > 25mmHg after treatment with 2 or more intraocular hypotensive drugs) in the study eye; (8) Any active eye disease (such as active ocular infection, history of choroidal hemorrhage, etc.) that restricts the subject's participation in the study as judged by the investigator; (9) Cataract surgery and YAG posterior capsular incision were performed on the study eye within 3 months prior to screening; (10) Pregnant or lactating patients, uncontrolled hypertension within 3 months, cerebrovascular accident or myocardial infarction, uncontrolled diabetes, or other reasons that cannot cooperate with relevant examinations; (11) Known hypersensitivity to any ingredient in the investigational drug, sodium fluorescein or local anesthetic; (12) All subjects of childbearing potential (male and female) must agree to use an acceptable method of contraception for the duration of their participation in the study. (13) One-eyed patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| best corrected visual acuity;central retinal thickness; | — |
Secondary
| Measure | Time frame |
|---|---|
| best corrected visual acuity;central retinal thickness;Changes of inflammatory biomarkers on OCT before and after treatment;The difference in the number of treatments between the two groups at 6 months; | — |
Countries
China
Contacts
Public ContactZuhua Sun
Eye Hospital, Wenzhou Medical University
Outcome results
None listed