Efficacy of Aliskiren in the Treatment of Diabetic Macular Edema

Diabetic Macular Edema Clinical Trial

Official title:

A Randomized, Double-masked, Placebo-controlled, add-on Study to Assess the Efficacy of Oral Aliskiren 300 mg Once Daily for Diabetic Macular Edema

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00768040
• Other study ID #: CSPP100A2244
• Secondary ID: EudraCT 2008-005
• Status: Terminated
• Phase: Phase 2
• First received: October 6, 2008
• Last updated: February 2, 2012
• Start date: September 2008
• Est. completion date: February 2011

Study information

• Verified date: February 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• Aliskiren
300 mg once daily
• Placebo
Matching placebo once daily

Locations

Country	Name	City	State
Denmark	Novartis Investigative Site	Arhus
Denmark	Novartis Investigative Site	Copenhagen
United States	Georgia Retina	Atlanta	Georgia
United States	Elman Retina Group	Baltimore	Maryland
United States	Retina-Associates of Cleveland, Inc	Beachwood	Ohio
United States	Joslin Clinic	Boston	Massachusetts
United States	Charlotte Eye, Ear, Nose and Throat Associate	Charlotte	North Carolina
United States	National Ophthalmic Research Institute	Fort Myers	Florida
United States	Vitreo-Retinal Associates	Grand Rapids	Michigan
United States	Retinal Consultants of Houston	Houston	Texas
United States	Retina-Vitreous Associates	Los Angeles	California
United States	Retinal Consultants of Arizona	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline to week 12	No