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

Not Applicable

Completed

• Conditions: Anti-VEGF Therapy

• Registration Number: NCT07096713
• Lead Sponsor: Benha University

Brief 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.

Study Timeline

• Status Verified: 2023-01
• Study Start: 2024-01-01
• Primary Completion: 2024-06-01
• Study Completion: 2024-06-01
• Study First Submitted: 2025-07-24
• Study First Submitted QC: 2025-07-24
• Last Update Submitted: 2025-07-24
• Study First Posted: 2025-07-31
• Last Update Posted: 2025-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Patients diagnosed with center-involving diabetic macular edema (DME) confirmed by spectral-domain optical coherence tomography (SD-OCT).
• Central macular thickness (CMT) > 350 µm at baseline.
• Treatment-naïve patients (no prior intravitreal injections or laser therapy for DME).

Exclusion Criteria

• Patients with media opacity (e.g., corneal opacities, dense vitreous hemorrhage).
• Significant cataract affecting visual acuity or OCT imaging quality.
• Traction maculopathy or vitreomacular traction.
• Central macular thickness < 350 µm at baseline.
• History of vasculitis or autoimmune diseases (e.g., systemic lupus erythematosus [SLE]).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Best-Corrected Visual Acuity (BCVA) from Baseline to 6 Months	Baseline and 6 months	Measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart or Snellen equivalent, converted to logMAR. The primary measure is the mean change in BCVA after treatment with either Brolucizumab or Aflibercept.
Change in Central Retinal Thickness (CRT) from Baseline to 6 Months	Baseline and 6 months	Assessed by spectral-domain optical coherence tomography (SD-OCT). The outcome is the mean change in CRT in micrometers, reflecting anatomical response to treatment.

Secondary Outcome Measures

Name	Time	Method
Total Number of Intravitreal Injections Over 6 Months	From baseline to month 6	The cumulative number of injections each patient received, to compare treatment burden between groups.

Trial Locations

Locations (1)

Benha University; 🇪🇬 Banha, Cairo, Egypt