diabetic retinopathy
Conditions
Interventions
Experimental group:intravitreal injection of Conbercept
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signing the informed consent and following up according to the time schedule of the study; 2. Aged >=18 years; 3. Type I or Type II diabetic mellitus; 4. The study eye must meet the following criteria: (1) Fundus examination showed that the degree of retinopathy reached sNPDR classification standard (referring to DR international clinical classification standard 2002, ETDRS standard seven field color fundus photography was independently evaluated and confirmed by two film readers); (2) OCT examination showed that DME involved the fovea and led to visual loss (spectral domain OCT was used, and CRT measurements were independently evaluated and confirmed by two film readers); (3) Refractive media opacification and mydriasis without affecting fundus examination; (4) Only one eye of each patient can be selected for studying. If both eyes meet the inclusion criteria, the researcher will determine the study eye from the medical perspective.
Exclusion criteria
Exclusion criteria: 1. In addition to diabetic retinopathy, there are other ophthalmic conditions (such as RVO, CNV, retinal detachment, macular hole, macular traction, epiretinal membrane, etc.) that cause macular edema or visual changes; 2. Patients with uncontrolled glaucoma (defined as IOP>=25 mmHg after treatment with anti-glaucoma drugs), or with a history of glaucoma filtering surgery; 3. Corticosteroids (such as triamcinolone acetonide) have been injected into the eyes within 3 months, or have been injected with corticosteroids around the eyes within 1 month; 4. Patients have received PRP, or more than 2 local/grid retinal photocoagulation, or local/grid retinal photocoagulation within 3 months; 5. Patients have received anti-VEGF drugs (such as aflibercept, ranibizumab, bevacizumab) within 6 months; 6. Those who have participated in any drug clinical trials in the last 3 months; 7. The researchers believe that the patient need to be excluded. For example, cataract may affect the judgment of examination or test results, or surgery is needed in the next 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best Corrected Visual Acuity; | — |
Secondary
| Measure | Time frame |
|---|---|
| proportion of patients with DRSS>=2 levels regression;proportion of patients with PRP;central retinal thickness; | — |
Countries
China
Contacts
Public ContactTao Sun
Department of Ophthalmology, Shanghai General Hospital
Outcome results
None listed