Diabetic macular edema (with moderate to severe non-proliferative diabetic retinopathy)
Conditions
Interventions
Combined treatment group with Compound Danshen dripping pills and anti-VEGF drugs.:Intravitreal injection of anti-VEGF agents (in the "3+PRN" regimen) and oral administration of Compound Danshen.
The group treated solely with anti-VEGF drugs:Administered only via intravitreal injection of the anti-VEGF agent (Aflibercept), strictly adhered to the "3+PRN" regimen, with the administration method
Sponsors
Shanghai Tenth People's Hospital
Eligibility
Sex/Gender
All
Age
45 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent form; 2. Aged between 45 and 80 years old; 3. Diagnosed with moderate to severe NPDR combined with macular edema through fundus imaging examinations; 4. No intravitreal anti-angiogenic drug injections, photodynamic therapy, or retinal laser photocoagulation within the past 3 months; 5. No systemic or local use of corticosteroids or triamcinolone within the past 3 months; 6. Stable blood glucose control.
Exclusion criteria
Exclusion criteria: 1. Any history of major medical conditions or major surgical history within 1 month prior to screening; 2. Active ocular infection in the study eye or the fellow eye; 3. Previous history of intraocular surgery, such as glaucoma surgery or retinal detachment surgery; 4. Allergic reaction or allergy history to sodium fluorescein, or allergy history to protein-based products used for treatment or diagnosis; 5. Suffering from other systemic diseases, such as infectious diseases, hematological diseases, immune disorders, psychiatric conditions, and other cardiovascular diseases.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best Corrected Visual Acuity (BCVA);Fundus Vascular Density; | — |
Secondary
| Measure | Time frame |
|---|---|
| Subretinal fluid; | — |
Countries
China
Contacts
Public ContactQing Peng
Shanghai Tenth People's Hospital
Outcome results
None listed