Benha University
Banha, Cairo Governorate, 13111, Egypt
NCT Number: NCT07096713
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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Interventional
Not applicable
Banha, Cairo Governorate, 13111, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intravitreal injection of Brolucizumab (6 mg/0.05 mL) for the treatment of center-involving diabetic macular edema.
Intravitreal injection of Aflibercept (2 mg/0.05 mL) for the treatment of center-involving diabetic macular edema.
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.
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.
Time frame: From baseline to month 6
The cumulative number of injections each patient received, to compare treatment burden between groups.
Benha University
Other
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
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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.