Efficacy of Aliskiren in the Treatment of Diabetic Macular Edema

Phase 2

Terminated

• Conditions: Diabetic Macular Edema
• Interventions: Drug: Aliskiren; Drug: Placebo

• Registration Number: NCT00768040
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-10-06
• Study First Submitted QC: 2008-10-06
• Study First Posted: 2008-10-07
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2012-02
• Results First Submitted: 2012-02-02
• Results First Submitted QC: 2012-02-02
• Last Update Submitted: 2012-02-02
• Results First Posted: 2012-03-06
• Last Update Posted: 2012-03-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aliskiren 300 mg	Aliskiren	Aliskiren 300 mg once daily for 12 weeks
Placebo	Placebo	Matching placebo once daily for 12 weeks

Primary Outcome Measures

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

Trial Locations

Locations (11)

Retinal Consultants of Arizona; 🇺🇸 Phoenix, Arizona, United States

Elman Retina Group; 🇺🇸 Baltimore, Maryland, United States

Vitreo-Retinal Associates; 🇺🇸 Grand Rapids, Michigan, United States

Retina-Vitreous Associates; 🇺🇸 Los Angeles, California, United States

Georgia Retina; 🇺🇸 Atlanta, Georgia, United States

National Ophthalmic Research Institute; 🇺🇸 Fort Myers, Florida, United States

Joslin Clinic; 🇺🇸 Boston, Massachusetts, United States

Charlotte Eye, Ear, Nose and Throat Associate; 🇺🇸 Charlotte, North Carolina, United States

Retinal Consultants of Houston; 🇺🇸 Houston, Texas, United States

Novartis Investigative Site; 🇩🇰 Copenhagen, Denmark

Retina-Associates of Cleveland, Inc; 🇺🇸 Beachwood, Ohio, United States