Comparison of Bevacizumab and Aflibercept in Treatment of Diabetic Macular Edema

NCT ID: NCT07338097

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-07
• Study Completion Date: 2026-02-07

Brief 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group Aflibercept

Participants will receive intravitreal aflibercept administered as 2.0 mg injection, given monthly for two months.

Group Type: EXPERIMENTAL

Aflibercept (2.0 mg)

Intervention Type: DRUG

Intravitreal aflibercept 2.0 mg, administered once monthly for two consecutive months.

Group Bevacizumab

Participants will receive intravitreal bevacizumab administered as 1.25 mg injection, given monthly for two months

Group Type: ACTIVE_COMPARATOR

Bevacizumab

Intervention Type: DRUG

Intravitreal bevacizumab 1.25 mg, administered once monthly for two consecutive months.

Interventions

Aflibercept (2.0 mg)

Intravitreal aflibercept 2.0 mg, administered once monthly for two consecutive months.

Intervention Type: DRUG

Bevacizumab

Intravitreal bevacizumab 1.25 mg, administered once monthly for two consecutive months.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CMH Multan Institute of Medical Sciences

OTHER_GOV

Sponsor Role: lead

Responsible Party

Sana Javed

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sana Javed

Role: PRINCIPAL_INVESTIGATOR

CMH Institute of Medical Sciences

Locations

CMH Institute of Medical Sciences

Multan, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

CIMS1

Identifier Type: -

Identifier Source: org_study_id