NCT06850571

Aflibercept and Bevacizumab for Diabetic Maculopathies

Evaluation of the Clinical Outcomes and Cost-effectiveness of Aflibercept and Bevacizumab in Iraqi Patients With Diabetic Maculopathies: Open Label Parallel Groups Clinical Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Al-Mustansiriyah University · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to to evaluate the clinical outcomes following treatment with bevacizumab versus aflibercept. These outcomes include: * Functional changes: The visual outcomes achieved by testing visual acuity * Anatomical changes: macular thickness and edema by optical coherence tomography (OCT).

Detailed description

Brief summary template The goal of this clinical trial is to to evaluate the clinical outcomes following treatment with bevacizumab versus aflibercept. These outcomes include: * Functional changes: The visual outcomes achieved by testing visual acuity * Anatomical changes: macular thickness and edema by optical coherence tomography (OCT). The secondary objectives include: * Analyze the cost-effectiveness of bevacizumab versus aflibercept in the management of diabetic maculopathies. * Safety profile and adverse events reported with bevacizumab and aflibercept use and their association with changes functioning changes Patients inclusion criteria include patients both sexes, age over 40 years with type 2 diabetes mellites diagnosed with diabetic maculopathies; those patients with reduced or reducing vision (6/9-6/90) according to visual acuity and significant foveolar thickening on OCT (more than 250 μm). Researchers will compare patients with intravitreal anti-VEGF treatment, aflibercept or bevacizumab for three successive monthly injections to see if there are any differences in safety and efficacy between the two arms. Participants will take aflibercept or bevacizumab intravitreally every month for 3 months Visit the clinic once every 1 month for checkups and assessment the pre- and post- 3 month anti-VEGF treatment values and findings by: * Pneumotonometry will be used to measure intraocular pressure (IOP) * Central foveal thickness (CFT) will be measured by optical coherence tomography (OCT). * Visual acuity (by Snellen visual acuity chart) will be assessed. * Pretreatment serum VEGF levels and 7-days after the third anti-VEGF dose

Conditions

• Diabetic Maculopathy

Interventions

Type	Name	Description
DRUG	Bevacizumab Injection [Avastin]	1.25 mg intravitreal injection given once monthly for three consecutive months.
DRUG	Aflibercept 2Mg/0.05Ml Inj,Oph	2.0 mg intravitreal injection given once monthly for three consecutive months.

Timeline

• Start date: 2025-02-20
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2025-02-27
• Last updated: 2025-09-19

Locations

1 site across 1 country: Iraq