Diabetic macular edema. Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy with macular edema
Conditions
Interventions
Intervention 1: Intervention group 1: Participants in this group receive intravitreal aflibercept injection (2 mg/0.05 mL). Injections are administered monthly if the central subfield thickness (CST)
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Adults over 18 years old with diabetic macular edema (DME) Central macular thickness (CMT) greater than 300 micrometers (measured with a Heidelberg device) Visual acuity (VA) between 20/40 and 20/400 History of vitrectomy (at least 4 months before entering the study) Presentation to (or follow-up at) Torfeh and Imam Hossein hospitals
Exclusion criteria
Exclusion criteria: HgbA1C > 8 High-risk PDR requiring early PRP Previous treatment with intravitreal or peri-bulbar triamcinolone injection within the past 3 months History of intraocular surgery within the past 4 months History of vitrectomy performed for trauma management Presence of silicone oil in the vitreous cavity Macular edema due to a cause other than diabetic retinopathy Significant cataract causing more than 3 lines of visual acuity loss Uveitis, NVG, exudative AMD Uncontrolled glaucoma History of steroid-induced elevated IOP
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decrease in diabetic macular edema. Timepoint: before intervention and every month for 6 months. Method of measurement: optic coherence tomography. | — |
Secondary
| Measure | Time frame |
|---|---|
| Increase visual acuity. Timepoint: before intervention and every month for 6 months. Method of measurement: snellen chart. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactReihaneh Dehghani
Shahid Beheshti University of Medical Sciences
Outcome results
None listed