Brolucizumab Versus Aflibercept on Visual and Anatomical Outcomes in Diabetic Macular Edema (Anti-VEGF)

Benha University

Status: Completed

Conditions: Anti-VEGF Therapy

Treatments: Drug: Intervention 1: Brolucizumab; Drug: Intervention 2: Aflibercept

Study type: Interventional

Funder types: Other

Identifiers

NCT07096713

Brolucizumab Vs Aflibercept

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Volunteers: No Healthy Volunteers

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]).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Arm 1: Brolucizumab Group

Experimental group

Description:

Description: This group included 19 eyes of 19 patients who received intravitreal Brolucizumab (6 mg/0.05 mL) injections for center-involving diabetic macular edema. Intervention Type: Drug Intervention Name: Brolucizumab 6 mg Dose/Frequency: Administered intravitreally as needed based on clinical evaluation

Treatment:

Drug: Intervention 1: Brolucizumab

Arm 2: Aflibercept Group

Active Comparator group

Description:

This group included 19 eyes of 19 patients who received intravitreal Aflibercept (2 mg/0.05 mL) injections for center-involving diabetic macular edema. Intervention Type: Drug Intervention Name: Aflibercept 2 mg Dose/Frequency: Administered intravitreally as needed based on clinical evaluation

Treatment:

Drug: Intervention 2: Aflibercept