Efficacy of Aliskiren in the Treatment of Diabetic Macular Edema

Phase 2TerminatedNCT00768040

Novartis Pharmaceuticals39 enrolled

Overview

To assess the efficacy of oral aliskiren as a therapy for diabetic macular edema

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Diabetic Macular Edema

Interventions

AliskirenDRUG

300 mg once daily

PlaceboDRUG

Matching placebo once daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion criteria: * Type 1 or type 2 diabetes * Diabetic macular edema Exclusion criteria: * Recent intra-ocular surgery in the study eye (e.g., cataract surgery in the last 6 months) * Recent laser photocoagulation in the study eye * Recent treatment with Avastin, Lucentis, or intravitreal corticosteroids in the study eye Other protocol-defined inclusion/exclusion criteria applied

Locations (12)

Retinal Consultants of Arizona

Phoenix, Arizona, United States

Retina-Vitreous Associates

Los Angeles, California, United States

National Ophthalmic Research Institute

Fort Myers, Florida, United States

Outcomes

Primary Outcomes

Change From Baseline in Central Retinal Thickness in Patients With Type 1 or Type 2 Diabetes, After 12 Weeks of Treatment

The central retinal thickness was measured by Optical coherence tomography (OCT). The changes in central retinal thickness (CRT) from baseline to the end of study at week 12 were analyzed using a univariate analysis of covariance model (ANCOVA) with baseline value as a covariate and treatment as a fixed factor

Time frame: Baseline to week 12

Data from ClinicalTrials.gov

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