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

Tehran University of Medical Sciences

Status and phase: Completed; Phase 2

Conditions: Diabetic Macular Edema

Treatments: Drug: Placebo; Drug: Losartan; Drug: Intravitreal bevacizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT02663141

9111257006

Details and patient eligibility

About

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).

Enrollment: 57 patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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57 participants in 2 patient groups, including a placebo group

Losartan

Experimental group

Description:

Oral losartan 50 mg daily for 6 months

Treatment:

Drug: Intravitreal bevacizumab

Drug: Losartan

Placebo

Placebo Comparator group

Description:

Oral placebo daily for 6 months

Treatment:

Drug: Intravitreal bevacizumab

Drug: Placebo