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Efficacy of Aliskiren in the Treatment of Diabetic Macular Edema

Primary Purpose

Diabetic Macular Edema

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Aliskiren
Placebo
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Diabetes, Macular edema, Aliskiren, Diabetic retinopathy, Diabetes mellitus type 1, Diabetes mellitus type 2

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Retinal Consultants of Arizona
  • Retina-Vitreous Associates
  • National Ophthalmic Research Institute
  • Georgia Retina
  • Elman Retina Group
  • Joslin Clinic
  • Vitreo-Retinal Associates
  • Charlotte Eye, Ear, Nose and Throat Associate
  • Retina-Associates of Cleveland, Inc
  • Retinal Consultants of Houston
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Aliskiren 300 mg

Placebo

Arm Description

Aliskiren 300 mg once daily for 12 weeks

Matching placebo once daily for 12 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 6, 2008
Last Updated
February 2, 2012
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00768040
Brief Title
Efficacy of Aliskiren in the Treatment of Diabetic Macular Edema
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 Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Terminated
Why Stopped
Inadequate enrollment
Study Start Date
September 2008 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
Diabetes, Macular edema, Aliskiren, Diabetic retinopathy, Diabetes mellitus type 1, Diabetes mellitus type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aliskiren 300 mg
Arm Type
Experimental
Arm Description
Aliskiren 300 mg once daily for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Aliskiren
Other Intervention Name(s)
SPP100
Intervention Description
300 mg once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo once daily
Primary Outcome Measure Information:
Title
Change From Baseline in Central Retinal Thickness in Patients With Type 1 or Type 2 Diabetes, After 12 Weeks of Treatment
Description
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
Time Frame
Baseline to week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Retinal Consultants of Arizona
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Retina-Vitreous Associates
City
Los Angeles
State/Province
California
Country
United States
Facility Name
National Ophthalmic Research Institute
City
Fort Myers
State/Province
Florida
Country
United States
Facility Name
Georgia Retina
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Elman Retina Group
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Joslin Clinic
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
MA
Country
United States
Facility Name
Vitreo-Retinal Associates
City
Grand Rapids
State/Province
Michigan
Country
United States
Facility Name
Charlotte Eye, Ear, Nose and Throat Associate
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
NC
Country
United States
Facility Name
Retina-Associates of Cleveland, Inc
City
Beachwood
State/Province
Ohio
Country
United States
Facility Name
Retinal Consultants of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
TX
Country
United States
Facility Name
Novartis Investigative Site
City
Arhus
Country
Denmark
Facility Name
Novartis Investigative Site
City
Copenhagen
Country
Denmark

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Aliskiren in the Treatment of Diabetic Macular Edema

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