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

Diabetic Macular Edema Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02663141
• Other study ID #: 9111257006
• Status: Completed
• Phase: Phase 2
• First received: January 21, 2016
• Last updated: July 3, 2016
• Start date: June 2015
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Macular Edema

Intervention

Drug:
• Losartan

• Intravitreal bevacizumab

• Placebo

Locations

Country	Name	City	State
Iran, Islamic Republic of	Farabi Eye Hospital	Tehran

Sponsors (2)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences	Farabi Eye Hospital

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	difference in ETDRS best-corrected visual acuity (BCVA) between arms		Within 6 months from therapy	No
Primary	Difference in frequency of intravitreal Bevacizumab injection between arms		Within 6 months from therapy	No
Secondary	change in central macular thickness(measured by spectral domain optical coherence tomography)		Within 6 months from therapy	No