Comparison of Bevacizumab and Aflibercept in Treatment of Diabetic Macular Edema

Sponsor
CMH Multan Institute of Medical Sciences
Study ID
NCT07338097
Status
Enrolling By Invitation

Conditions

  • Diabetic Macular Edema (DME)

Eligibility Criteria

Sex
ALL
Age
30 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Aflibercept (2.0 mg) — DRUG
    Intravitreal aflibercept 2.0 mg, administered once monthly for two consecutive months.
  • Bevacizumab — DRUG
    Intravitreal bevacizumab 1.25 mg, administered once monthly for two consecutive months.

Study Details

Diabetic macular edema is a frequent complication of long-standing diabetes mellitus in which fluid leaks into the central part of the retina (macula), leading to reduced vision. This randomized controlled trial will be conducted at Combined Military Hospital, Multan, to compare two commonly used intravitreal anti vascular endothelial growth factor medicines, aflibercept and bevacizumab, in adults aged 30 to 60 years with type 1 or type 2 diabetes mellitus for at least 5 years, central macular thickness of at least 300 micrometers on optical coherence tomography, and reduced baseline visual acuity (20/50 or worse). Eligible participants will be allocated in a 1:1 ratio to receive either intravitreal aflibercept 2.0 mg or intravitreal bevacizumab 1.25 mg, administered monthly for two months, with follow-up assessments at 1 and 2 months. The primary hypothesis is that aflibercept produces a greater average improvement in visual acuity than bevacizumab in this patient group. The primary outcome is the mean change in visual acuity measured as Early Treatment Diabetic Retinopathy Study letter score from baseline to 2 months. The secondary outcome is the mean change in central retinal thickness on optical coherence tomography.

Key Dates

Start date
Sep 7, 2025
Status verified
Jan 2026
Primary completion
Feb 7, 2026
Completion
Feb 7, 2026

Study Design

Enrollment
116 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group Aflibercept
    Participants will receive intravitreal aflibercept administered as 2.0 mg injection, given monthly for two months.
  • Active Comparator: Group Bevacizumab
    Participants will receive intravitreal bevacizumab administered as 1.25 mg injection, given monthly for two months

Primary Outcome Measure

Mean Change in Visual Acuity Letter Score [ Time Frame: Baseline assessment before first injection and follow up evaluation at the end of 2 months after initiation of treatment. ]

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