Aflibercept and Bevacizumab for Diabetic Maculopathies

Conditions

• Diabetic Maculopathy

Eligibility Criteria

Sex

ALL

Age

40 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bevacizumab Injection [Avastin] — DRUG
  1.25 mg intravitreal injection given once monthly for three consecutive months.
• Aflibercept 2Mg/0.05Ml Inj,Oph — DRUG
  2.0 mg intravitreal injection given once monthly for three consecutive months.

Study Details

The goal of this clinical trial is to to evaluate the clinical outcomes following treatment with bevacizumab versus aflibercept. These outcomes include: * Functional changes: The visual outcomes achieved by testing visual acuity * Anatomical changes: macular thickness and edema by optical coherence tomography (OCT).

Key Dates

Start date

Feb 20, 2025

Status verified

Sep 2025

Primary completion

Dec 1, 2025

Completion

Dec 1, 2025

Study Design

Enrollment

102 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Bevacizumab group
  Patients will receive an intravitreal injection of 1.25 mg (in 0.05 ml solution) of bevacizumab once monthly for three consecutive months.
• Experimental: Aflibercept group
  Patients will receive an intravitreal injection of 2.0 mg (in 0.05 ml solution) of aflibercept once monthly for three consecutive months.

Primary Outcome Measure

Visual accuty assessed by snellen chart [ Time Frame: one day before start of treatment, and after 3 months of starting the treatment ]