NCT07338097

Comparison of Bevacizumab and Aflibercept in Treatment of Diabetic Macular Edema

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: CMH Multan Institute of Medical Sciences · Other Government
• Sex: All
• Age: 30 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Diabetic Macular Edema (DME)

Interventions

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

Timeline

• Start date: 2025-09-07
• Primary completion: 2026-02-07
• Completion: 2026-02-07
• First posted: 2026-01-13
• Last updated: 2026-01-13

Locations

1 site across 1 country: Pakistan