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

Conditions

• Anti-VEGF Therapy

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

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

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 Group
  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
• Active Comparator: Arm 2: Aflibercept Group
  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

Primary Outcome Measure

Change in Best-Corrected Visual Acuity (BCVA) from Baseline to 6 Months [ Time Frame: Baseline and 6 months ]