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Efficacy of Aliskiren in the Treatment of Diabetic Macular Edema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00768040
Recruitment Status : Terminated (Inadequate enrollment)
First Posted : October 7, 2008
Results First Posted : March 6, 2012
Last Update Posted : March 6, 2012
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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Brief Summary:
To assess the efficacy of oral aliskiren as a therapy for diabetic macular edema

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: Aliskiren Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : September 2008
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Aliskiren

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00768040


Locations
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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
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00768040    
Other Study ID Numbers: CSPP100A2244
EudraCT 2008-00581-23
First Posted: October 7, 2008    Key Record Dates
Results First Posted: March 6, 2012
Last Update Posted: March 6, 2012
Last Verified: February 2012
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Diabetes
Macular edema
Aliskiren
 Diabetic retinopathy
Diabetes mellitus type 1
Diabetes mellitus type 2
Additional relevant MeSH terms:
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Macular Edema
Edema
Macular Degeneration
 Retinal Degeneration
Retinal Diseases
Eye Diseases