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

July 3, 2016 updated by: Tehran University of Medical Sciences
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Phase 2

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

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
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Losartan
Oral losartan 50 mg daily for 6 months
Drug: Intravitreal bevacizumab
Other Names:
  • Avastin
Drug: Losartan
PLACEBO_COMPARATOR: Placebo
Oral placebo daily for 6 months
Drug: Placebo
Drug: Intravitreal bevacizumab
Other Names:
  • Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
difference in ETDRS best-corrected visual acuity (BCVA) between arms
Time Frame: Within 6 months from therapy
Within 6 months from therapy
Difference in frequency of intravitreal Bevacizumab injection between arms
Time Frame: Within 6 months from therapy
Within 6 months from therapy

Secondary Outcome Measures

Outcome Measure
Time Frame
change in central macular thickness(measured by spectral domain optical coherence tomography)
Time Frame: Within 6 months from therapy
Within 6 months from therapy

Collaborators and Investigators

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

Sponsor

Tehran University of Medical Sciences

Collaborators

Farabi Eye Hospital

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

June 1, 2015

Primary Completion (ACTUAL)

June 1, 2016

Study Completion (ACTUAL)

June 1, 2016

Study Registration Dates

First Submitted

January 21, 2016

First Submitted That Met QC Criteria

January 25, 2016

First Posted (ESTIMATE)

January 26, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

July 6, 2016

Last Update Submitted That Met QC Criteria

July 3, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9111257006

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.

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Locations

3
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