NCT07096713

Brolucizumab Versus Aflibercept on Visual and Anatomical Outcomes in Diabetic Macular Edema

Evaluating the Efficacy and Safety of Brolucizumab Versus Aflibercept on Visual and Anatomical Outcomes in Diabetic Macular Edema: A Retrospective Comparative Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Benha University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This retrospective, comparative cohort study included 38 eyes from 38 patients with center-involving diabetic macular edema (DME), treated at Benha University Hospital. Patients were divided into two groups: 19 eyes received intravitreal Brolucizumab (6 mg), and 19 eyes received intravitreal Aflibercept (2 mg), with the aim of comparing their efficacy and safety over a 6-month period.

Detailed description

The study retrospectively evaluated real-world outcomes of anti-VEGF therapy in treatment-naïve patients with center-involving DME. Participants were assigned into two equal groups based on the anti-VEGF agent received: Group A was treated with intravitreal Brolucizumab (6 mg), and Group B with intravitreal Aflibercept (2 mg). All patients underwent comprehensive ophthalmic evaluation at baseline and at monthly intervals, including best-corrected visual acuity (BCVA) assessment and optical coherence tomography (OCT) to monitor central retinal thickness (CRT). The primary outcomes were changes in BCVA and CRT from baseline to 6 months, while secondary outcomes included the number of injections received and any adverse events. This study aimed to provide comparative insights into the efficacy, anatomical response, and safety profile of the two anti-VEGF agents in managing DME in a real-world clinical setting.

Conditions

• Anti-VEGF Therapy

Interventions

Type	Name	Description
DRUG	Intervention 1: Brolucizumab	Intravitreal injection of Brolucizumab (6 mg/0.05 mL) for the treatment of center-involving diabetic macular edema.
DRUG	Intervention 2: Aflibercept	Intravitreal injection of Aflibercept (2 mg/0.05 mL) for the treatment of center-involving diabetic macular edema.

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2025-07-31
• Last updated: 2025-07-31

Locations

1 site across 1 country: Egypt