Comparing Aflibercept and Bevacizumab Treatments for Diabetic Maculopathies in Adults Over 40 Years A Phase 4 Open Label Clinical Trial in Iraq

What this Trial Is About

Researchers are evaluating the clinical outcomes of two treatments, bevacizumab and aflibercept, in patients with diabetic maculopathies, a condition affecting the eyes due to diabetes. The study focuses on changes in visual function by testing visual acuity and anatomical changes by measuring macular thickness and edema using optical coherence tomography OCT. It also aims to analyze the cost-effectiveness and safety profiles of these treatments, including any adverse events linked to changes in visual function. Participants will receive either bevacizumab or aflibercept through intravitreal injections once a month for three consecutive months. Bevacizumab is given as a 1.25 mg dose, and aflibercept as a 2.0 mg dose, both in a 0.05 ml solution. The study is open-label and compares these two groups in parallel to assess differences in safety and efficacy. During the study, participants will visit the clinic monthly for checkups before and after the three-month treatment period. Assessments include measuring intraocular pressure using pneumotonometry, central foveal thickness by OCT, and visual acuity using a Snellen chart. Researchers will also measure serum VEGF levels before treatment and seven days after the third dose. Outcome measures include visual acuity, macular thickness, treatment-related adverse events, quality of life, and adherence to therapy.

Aflibercept and Bevacizumab for Diabetic Maculopathies