Randomized Clinical Trial of Intravitreal Bevacizumab Versus Intravitreal Bevacizumab Combined With Losartan in the Treatment of Diabetic Macular Edema
- Sponsor
- Tehran University of Medical Sciences
- Study ID
- NCT02663141
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Losartan — DRUG
- Intravitreal bevacizumab — DRUG
- Placebo — DRUG
Study Details
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).
Key Dates
- First listed
- Jan 26, 2016
- Start date
- Jun 30, 2015
- Status verified
- Jul 2016
- Primary completion
- Jun 30, 2016
- Completion
- Jun 30, 2016
Study Design
- Enrollment
- 57 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: LosartanOral losartan 50 mg daily for 6 months
- Placebo Comparator: PlaceboOral placebo daily for 6 months
Primary Outcome Measure
difference in ETDRS best-corrected visual acuity (BCVA) between arms [ Time Frame: Within 6 months from therapy ]
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- EC-104 Intravitreal Implant for the Treatment of Diabetic Macular EdemaPHASE1/PHASE2 · Recruiting · Eclipse Life Sciences, Inc. · Tampa, Florida
- Intranasal Delivery of Octreotide for Treatment of Diabetic Macular EdemaPHASE1 · Not Yet Recruiting · University of Alabama at Birmingham · Birmingham, Alabama
- Phase 2 Trial of RGX-314 in Adults With Center Involved - Diabetic Macular Edema (CI - DME)PHASE2 · Recruiting · Sierra Eye Associates · Reno, Nevada