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Comparison of Bevacizumab and Aflibercept in Treatment of Diabetic Macular Edema

NCT07338097 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2026-01-13

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • CMH Multan Institute of Medical Sciences

    lead OTHER_GOV

Principal Investigators

  • Sana Javed · CMH Institute of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-07
Primary Completion
2026-02-07
Completion
2026-02-07

Countries

  • Pakistan

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07338097 on ClinicalTrials.gov