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

NCT ID: NCT02663141

Last Updated: 2016-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Diabetic Macular Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Losartan

Oral losartan 50 mg daily for 6 months

Group Type EXPERIMENTAL

Losartan

Intervention Type DRUG

Intravitreal bevacizumab

Intervention Type DRUG

Placebo

Oral placebo daily for 6 months

Group Type PLACEBO_COMPARATOR

Intravitreal bevacizumab

Intervention Type DRUG

Placebo

Intervention Type DRUG

Interventions

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Losartan

Intervention Type DRUG

Intravitreal bevacizumab

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Avastin

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Farabi Eye Hospital

OTHER

Sponsor Role collaborator

Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Farabi Eye Hospital

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

Other Identifiers

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9111257006

Identifier Type: -

Identifier Source: org_study_id

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