Diabetic Macular Edema
Conditions
Interventions
Concrol group:Intravitreal injection of conbercept 0.5mg (0.05ml) with a 3 + PRN regimen (3 initial monthly injections, followed by additional injections as needed).
Combination therapy group:The same conbercept injection regimen as the control group, combined with oral administration of difrarel (three tablets two times daily, for 30 days per month, for a total o
Sponsors
Huizhou Baijirui Pharmaceutical Company Limited
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years, with documented diagnosis of diabetes mellitus (type 1 or type 2) according to the American Diabetes Association or WHO criteria; 2. The primary cause of decreased visual acuity is diabetic macular edema(DME); 3. At screening and baseline, examination optical coherence tomography(OCT) demonstrated diabetic macular edema involving the foveal center in the study eye, with central retinal thickness >= 325 µm. 4. Best corrected visual acuity (BCVA) of the study eye within the range of 0.06–0.5 measured using the standard logarithmic visual acuity chart at screening and baseline; 5. Glycemic control criteria: glycated hemoglobin (HbA1c) <= 9.0% (based on the value closest to enrollment within the three months prior to enrollment); 6. Blood pressure control criteria: seated systolic blood pressure <= 150 mmHg and diastolic blood pressure <= 95 mmHg (stable doses of antihypertensive medications are permitted); 7. Lipid control criteria: fasting triglyceride (TG) <= 5.6 mmol/L, total cholesterol (TC) <= 7.2 mmol/L (or within 1.5 times the upper limit of the normal range according to the local laboratory reference values); 8. Willing and able to provide signed informed consent; 9. Willing and able to complete all scheduled visits and assessments (e.g., multiple OCT, visual acuity tests).
Exclusion criteria
Exclusion criteria: 1. Presence of non-diabetic macular edema, active proliferative diabetic retinopathy (PDR), uncontrolled glaucoma, rubeosis iridis, neovascular glaucoma, or intraocular pressure (IOP) >=25 mmHg in either eye; 2. Receipt of anti-VEGF agents, corticosteroids, or macular/panretinal laser photocoagulation in the study eye within the past 3 months; 3. History of vitrectomy, cataract surgery, or other intraocular surgery in the study eye within the past 6 months; 4. Active ocular surface or intraocular infection/inflammation; 5. Severe systemic diseases (e.g., cardiovascular, cerebrovascular, hepatic or renal insufficiency) or other conditions that the investigator deems unsuitable for enrollment; 6. Pregnant or lactating women; 7. Non-study eye with loss of function, defined as best-corrected visual acuity (BCVA) of hand motion or worse, or patients with only one functional eye.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in central foveal thickness;Changes in best corrected visual acuity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Retinal structural improvement;Rate of vision stability or deterioration;Microvascular morphology and hemodynamic parameters;Safety; | — |
Countries
China
Contacts
Public ContactBojie Hu
Tianjin Medical University Zhu Xianyi Memorial Hospital
Outcome results
None listed