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OpenTrials
Completed

NCT Number: NCT02663141

Randomized Clinical Trial of Intravitreal Bevacizumab Versus Intravitreal Bevacizumab Combined With Losartan in the Treatment of Diabetic Macular Edema

The aim of this study is to determine whether oral losartan is effective in the treatment of diabetic macular edema (DME) as an adjuvant for intravitreal bevacizumab (IVB).

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Key information

Conditions

Diabetic Macular Edema

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Farabi Eye Hospital

Tehran, Tehran Province, Iran

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

All type 2 diabetes mellitus patients with clinically significant macular edema(CSME), except those mentioned as exclusion criteria

Exclusion criteria

  • Patients with Uncontrolled hypertension
  • Patients with Proliferative diabetic retinopathy
  • Patients Who received angiotensin converting enzyme inhibitor(ACEI) or angiotensin receptor blocker(ARB)
  • Previous treatment for diabetic retinopathy (e.g., laser photocoagulation, photodynamic therapy, intravitreal injections of steroids, or anti-vascular endothelial growth factor, retinal surgery)
  • media opacities
  • evidence of any other ocular disease(e.g., glaucoma, uveitis, age related macular degeneration or etc.,)
  • Pathologic myopia > 6 Diopter
  • Patients with poor fixation or cooperation
  • Patients with renal or cardiac disease

Treatment and study plan

Losartan

Drug

Intravitreal Bevacizumab

Drug

Other names: Avastin

Placebo

Drug

Primary outcomes

  1. difference in ETDRS best-corrected visual acuity (BCVA) between arms

    Time frame: Within 6 months from therapy

  2. Difference in frequency of intravitreal Bevacizumab injection between arms

    Time frame: Within 6 months from therapy

Secondary outcomes

  1. change in central macular thickness(measured by spectral domain optical coherence tomography)

    Time frame: Within 6 months from therapy

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Collaborators

  • Farabi Eye Hospital

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 26, 2016
Registry last updated
Jul 6, 2016

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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