Diabetic Macular Edema. Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy with macular edema
Conditions
Interventions
Intervention 1: Intervention group: Empagliflozin (10 or 25 mg once daily) plus intravitreal injection of anti-VEGF (Every 4 weeks). Intervention 2: Control group: Anti-VEGF intravitreal injection onl
Sponsors
Bagheiat-allah University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Diabetic macular edema (DME) diagnosis by optical coherence tomography (OCT) Compliance with diabetes diagnostic criteria Informed consent to participate in the study
Exclusion criteria
Exclusion criteria: Receiving any previous treatment for macular edema (such as anti-VEGF injections or laser) History of intravitreal injections, laser photocoagulation, or other treatments for macular edema in the past 6 months and other retinal or eye disorders that may affect macular edema (such as age-related macular degeneration or retinal vein occlusion) Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Central Macular Thickness. Timepoint: Month 0, 1, 2, and 3. Method of measurement: Optical coherence tomography (OCT) device. | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual acuity. Timepoint: Month 0, 1, 2, and 3. Method of measurement: BCVA (Best corrected visual acuity) score.;Fasting Blood Sugar. Timepoint: Month 0, 1.5, and 3. Method of measurement: Enzyme spectroscopy.;Hemoglobin A1C (HbA1C). Timepoint: Month 0, 1.5, and 3. Method of measurement: Enzyme spectroscopy. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHamidreza Torabi
Bagheiat-allah University of Medical Sciences
Outcome results
None listed