Brolucizumab Versus Aflibercept on Visual and Anatomical Outcomes in Diabetic Macular Edema
- Sponsor
- Benha University
- Study ID
- NCT07096713
- Status
- Completed
Conditions
- Anti-VEGF Therapy
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Intervention 1: Brolucizumab — DRUGIntravitreal injection of Brolucizumab (6 mg/0.05 mL) for the treatment of center-involving diabetic macular edema.
- Intervention 2: Aflibercept — DRUGIntravitreal injection of Aflibercept (2 mg/0.05 mL) for the treatment of center-involving diabetic macular edema.
Study Details
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.
Key Dates
- First listed
- Jul 31, 2025
- Start date
- Jan 1, 2024
- Status verified
- Jan 2023
- Primary completion
- Jun 1, 2024
- Completion
- Jun 1, 2024
Study Design
- Enrollment
- 38 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm 1: Brolucizumab GroupDescription: 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
- Active Comparator: Arm 2: Aflibercept GroupThis 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
Primary Outcome Measure
Change in Best-Corrected Visual Acuity (BCVA) from Baseline to 6 Months [ Time Frame: Baseline and 6 months ]