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OpenTrials
Enrolling by Invitation

NCT Number: NCT07338097

Comparison of Bevacizumab and Aflibercept in Treatment of Diabetic Macular Edema

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.

Enrolling by Invitation

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Key information

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CMH Institute of Medical Sciences

Multan, Punjab Province, 66000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aflibercept (2.0 mg)

Drug

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

Bevacizumab

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

CMH Multan Institute of Medical Sciences

Other Gov

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2026
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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