Diabetic Macular Edema (DME). Type 1 diabetes mellitus with unspecified diabetic retinopathy with macular edema
Conditions
Interventions
Intervention 1: Intervention group: Patients allocated to this group will receive standard intravitreal injections of bevacizumab (Avastin) at a dose of 1.25 mg in 0.05 mL, administered monthly for th
Sponsors
Ahvaz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients with type 1 or type 2 diabetes diagnosed with diabetic macular edema based on ophthalmic examinations and imaging. Central macular thickness greater than 320 micrometers. Age greater than 18 years. Absence of other ocular diseases such as glaucoma and uveitis.
Exclusion criteria
Exclusion criteria: History of eye surgery in the past 6 months. Presence of other retinal diseases or active inflammatory eye diseases. Presence of glaucoma or elevated intraocular pressure. Pregnancy or breastfeeding. Concurrent use of interacting medications. Simultaneous participation in another study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Central Macular Thickness - CMT. Timepoint: At study entry (baseline, before the first intervention/injection) and exactly 1 month after the third intravitreal injection (end of the third month or week 12). Method of measurement: Measurement of thickness in micrometers using an Optical Coherence Tomography (OCT) imaging device.;Best Corrected Visual Acuity - BCVA. Timepoint: At study entry (baseline, before initiation of the first intervention) and exactly one month after the third intravitreal injection (end of the third month or week 12). Method of measurement: Measurement using the Snellen visual acuity chart after precise determination of the patient’s refraction (sphere, cylinder, and axis), followed by conversion of the obtained values to the logarithm of the minimum angle of resolution (LogMAR) scale for accurate statistical analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Intraocular Pressure - IOP. Timepoint: At study entry, then every 4 weeks during scheduled follow-up visits (before each subsequent injection), and finally 1 month after the third injection. Method of measurement: Measurement in millimeters of mercury (mmHg) using the standard tonometry method.;Local and ocular adverse effects resulting from the use of eye drops and intravitreal injections, including eye redness, blurred vision, burning sensation, and inflammatory symptoms. Timepoint: Continuously; assessed and recorded at baseline and then every 4 weeks throughout the 3-month follow-up period. Method of measurement: Through a comprehensive ophthalmic examination using a slit-lamp, fundoscopy, and by questioning the patient and recording patient self-reported symptoms at each visit. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAli Kasiri
Ahvaz University of Medical Sciences
Outcome results
None listed