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OpenTrials
Completed

NCT Number: NCT07096713

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

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.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benha University

Banha, Cairo Governorate, 13111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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]).

Treatment and study plan

Intervention 1: Brolucizumab

Drug

Intravitreal injection of Brolucizumab (6 mg/0.05 mL) for the treatment of center-involving diabetic macular edema.

Intervention 2: Aflibercept

Drug

Intravitreal injection of Aflibercept (2 mg/0.05 mL) for the treatment of center-involving diabetic macular edema.

Primary outcomes

  1. Change in Best-Corrected Visual Acuity (BCVA) from Baseline to 6 Months

    Time frame: 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.

  2. Change in Central Retinal Thickness (CRT) from Baseline to 6 Months

    Time frame: 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 outcomes

  1. Total Number of Intravitreal Injections Over 6 Months

    Time frame: From baseline to month 6

    The cumulative number of injections each patient received, to compare treatment burden between groups.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Acronym: Anti-VEGF

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 31, 2025
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.