Efficacy of Aliskiren in the Treatment of Diabetic Macular Edema

February 2, 2012 updated by: Novartis Pharmaceuticals

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aliskiren 300 mg
Aliskiren 300 mg once daily for 12 weeks
Drug: Aliskiren
300 mg once daily
Other Names:
  • SPP100
Placebo Comparator: Placebo
Matching placebo once daily for 12 weeks
Drug: Placebo
Matching placebo once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline to week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

October 6, 2008

First Submitted That Met QC Criteria

October 6, 2008

First Posted (Estimate)

October 7, 2008

Study Record Updates

Last Update Posted (Estimate)

March 6, 2012

Last Update Submitted That Met QC Criteria

February 2, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPP100A2244
  • EudraCT 2008-00581-23

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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