Comparison of Bevacizumab and Aflibercept in Treatment of Diabetic Macular Edema

Enrolling by invitation · Not applicable

Conditions studied: Diabetic Macular Edema (DME)

In brief

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 facts

Study ID: NCT07338097
Run by: CMH Multan Institute of Medical Sciences
People needed: 116
Starts: 2025-09-07
Expected to finish: 2026-02-07
Last updated by the study team: 2026-01-13

Who can join

Age: 30 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients with type 1 or type 2 diabetes mellitus for ≥5 years
Baseline visual acuity of 20/50 or worse
Central macular thickness of ≥300 µm on OCT
Age 30 to 60 years
Either gender
Provided voluntary consent for participation

You may not qualify if…

History of prior treatment for DME: anti-VEGF, steroids, or laser.
Active ocular infection or inflammation
History of cardiac disease or stroke
Women who are pregnant or breastfeeding
Known allergy to Aflibercept or Bevacizumab
Patient refusals to participate in the study

Where it is running

CMH Institute of Medical Sciences — Multan, Punjab Province, Pakistan

Full record on ClinicalTrials.gov

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