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Efficacy of Aliskiren in the Treatment of Diabetic Macular Edema

This study has been terminated.
(Inadequate enrollment)
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00768040
First received: October 6, 2008
Last updated: February 2, 2012
Last verified: February 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Diabetic Macular Edema
 Drug: Aliskiren
Drug: Placebo
 Phase 2

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

Resource links provided by NLM:

Drug Information available for: Aliskiren
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change From Baseline in Central Retinal Thickness in Patients With Type 1 or Type 2 Diabetes, After 12 Weeks of Treatment [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]
    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


Enrollment: 39
Study Start Date: September 2008
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aliskiren 300 mg
Aliskiren 300 mg once daily for 12 weeks
 Drug: Aliskiren
300 mg once daily
Other Name: SPP100
Placebo Comparator: Placebo
Matching placebo once daily for 12 weeks
 Drug: Placebo
Matching placebo once daily

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00768040

Locations
United States, Arizona
Retinal Consultants of Arizona
Phoenix, Arizona, United States
United States, California
Retina-Vitreous Associates
Los Angeles, California, United States
United States, Florida
National Ophthalmic Research Institute
Fort Myers, Florida, United States
United States, Georgia
Georgia Retina
Atlanta, Georgia, United States
United States, Maryland
Elman Retina Group
Baltimore, Maryland, United States
United States, Massachusetts
Joslin Clinic
Boston, Massachusetts, United States, MA
United States, Michigan
Vitreo-Retinal Associates
Grand Rapids, Michigan, United States
United States, North Carolina
Charlotte Eye, Ear, Nose and Throat Associate
Charlotte, North Carolina, United States, NC
United States, Ohio
Retina-Associates of Cleveland, Inc
Beachwood, Ohio, United States
United States, Texas
Retinal Consultants of Houston
Houston, Texas, United States, TX
Denmark
Novartis Investigative Site
Arhus, Denmark
Novartis Investigative Site
Copenhagen, Denmark
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00768040     History of Changes
Other Study ID Numbers: CSPP100A2244, EudraCT 2008-00581-23
Study First Received: October 6, 2008
Results First Received: February 2, 2012
Last Updated: February 2, 2012
Health Authority: Denmark: Danish Medicines Agency
United States: Food and Drug Administration

Keywords provided by Novartis:
Diabetes
Macular edema
Aliskiren
 Diabetic retinopathy
Diabetes mellitus type 1
Diabetes mellitus type 2

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
 Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 23, 2013