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

Primary Purpose

Diabetic Macular Edema

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Losartan
Intravitreal bevacizumab
Placebo
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Farabi Eye Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Losartan

Placebo

Arm Description

Oral losartan 50 mg daily for 6 months

Oral placebo daily for 6 months

Outcomes

Primary Outcome Measures

difference in ETDRS best-corrected visual acuity (BCVA) between arms
Difference in frequency of intravitreal Bevacizumab injection between arms

Secondary Outcome Measures

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

Full Information

First Posted
January 21, 2016
Last Updated
July 3, 2016
Sponsor
Tehran University of Medical Sciences
Collaborators
Farabi Eye Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02663141
Brief Title
Randomized Clinical Trial of Intravitreal Bevacizumab Versus Intravitreal Bevacizumab Combined With Losartan in the Treatment of Diabetic Macular Edema
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tehran University of Medical Sciences
Collaborators
Farabi Eye Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Losartan
Arm Type
Experimental
Arm Description
Oral losartan 50 mg daily for 6 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral placebo daily for 6 months
Intervention Type
Drug
Intervention Name(s)
Losartan
Intervention Type
Drug
Intervention Name(s)
Intravitreal bevacizumab
Other Intervention Name(s)
Avastin
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
difference in ETDRS best-corrected visual acuity (BCVA) between arms
Time Frame
Within 6 months from therapy
Title
Difference in frequency of intravitreal Bevacizumab injection between arms
Time Frame
Within 6 months from therapy
Secondary Outcome Measure Information:
Title
change in central macular thickness(measured by spectral domain optical coherence tomography)
Time Frame
Within 6 months from therapy

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Farabi Eye Hospital
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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