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

Phase 2

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Drug: Losartan; Drug: Intravitreal bevacizumab; Drug: Placebo

• Registration Number: NCT02663141
• Lead Sponsor: Tehran University of Medical Sciences

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2016-01-21
• Study First Submitted QC: 2016-01-25
• Study First Posted: 2016-01-26
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-03
• Last Update Posted: 2016-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Losartan	Losartan	Oral losartan 50 mg daily for 6 months
Losartan	Intravitreal bevacizumab	Oral losartan 50 mg daily for 6 months
Placebo	Intravitreal bevacizumab	Oral placebo daily for 6 months
Placebo	Placebo	Oral placebo daily for 6 months

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
change in central macular thickness(measured by spectral domain optical coherence tomography)	Within 6 months from therapy

Trial Locations

Locations (1)

Farabi Eye Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of