Comparison of Bevacizumab and Aflibercept in Treatment of Diabetic Macular Edema

January 3, 2026 updated by: Sana Javed, CMH Multan Institute of Medical Sciences
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

116

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Multan, Punjab Province, Pakistan, 66000
        • CMH Institute of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group Aflibercept
Participants will receive intravitreal aflibercept administered as 2.0 mg injection, given monthly for two months.
Drug: Aflibercept (2.0 mg)
Intravitreal aflibercept 2.0 mg, administered once monthly for two consecutive months.
Active Comparator: Group Bevacizumab
Participants will receive intravitreal bevacizumab administered as 1.25 mg injection, given monthly for two months
Drug: Bevacizumab
Intravitreal bevacizumab 1.25 mg, administered once monthly for two consecutive months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The primary outcome is the average change in visual acuity expressed as Early Treatment Diabetic Retinopathy Study (ETDRS) letter score, calculated by converting Snellen visual acuity measurements. The change is determined by subtracting baseline letter score from the letter score measured at follow up. This metric reflects functional improvement in vision.
Baseline assessment before first injection and follow up evaluation at the end of 2 months after initiation of treatment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change in Central Retinal Thickness
Time Frame: Baseline assessment before first injection and follow up evaluation at the end of 2 months after initiation of treatment.
The secondary outcome is the average change in central retinal thickness measured in micrometers using optical coherence tomography. The change is calculated by comparing baseline thickness with the value measured at follow up. This outcome reflects anatomical response of the macula to treatment.
Baseline assessment before first injection and follow up evaluation at the end of 2 months after initiation of treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CMH Multan Institute of Medical Sciences

Investigators

  • Principal Investigator: Sana Javed, CMH Institute of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2025

Primary Completion (Estimated)

February 7, 2026

Study Completion (Estimated)

February 7, 2026

Study Registration Dates

First Submitted

January 3, 2026

First Submitted That Met QC Criteria

January 3, 2026

First Posted (Actual)

January 13, 2026

Study Record Updates

Last Update Posted (Actual)

January 13, 2026

Last Update Submitted That Met QC Criteria

January 3, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIMS1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetic Macular Edema (DME)

Clinical Trials on Aflibercept (2.0 mg)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe