Diabetic Macular Edema (DME)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged >=40 years, diagnosed with type 1 or type 2 diabetes mellitus. 2. Confirmed diagnosis of DME, with OCT examination showing CMT > 250 µm or the presence of definite intraretinal cysts. 3. The study eye is either treatment-naïve for anti-VEGF therapy, or has previously received anti-VEGF therapy but discontinued for >=6 months and currently meets the criteria for retreatment. 4. Voluntarily participate in the study and sign the informed consent form. 5. Able to cooperate in completing the OCTA examination and obtain high-quality images (signal strength >=7/10, free from significant motion artifacts).
Exclusion criteria
Exclusion criteria: 1. History of intraocular or periocular glucocorticoid injection within the previous 6 months. 2. History of macular grid laser photocoagulation or panretinal photocoagulation within the previous 3 months. 3. History of intraocular surgery (including cataract surgery) within the previous 3 months, or prior history of vitrectomy. 4. Presence of other ocular diseases that may cause macular edema, such as retinal vein occlusion, uveitis, neovascular age-related macular degeneration, etc. 5. Severe media opacity affecting OCT/OCTA image quality assessment (e.g., significant cataract, vitreous hemorrhage). 6. Presence of uncontrolled severe systemic diseases (e.g., uncontrolled hypertension, recent cardiovascular or cerebrovascular events). 7. Presence of ocular conditions that may affect OCTA signal quality (e.g., significant nystagmus, poor fixation).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Central Macular Thickness, CMT;Best Corrected Visual Acuity (BCVA); | — |
Secondary
| Measure | Time frame |
|---|---|
| Concentration of cytokines in aqueous humor, imaging biomarkers such as SRF and DCP; | — |
Countries
China
Contacts
Shanghai Tenth People's Hospital