NCT00768040

Brief Summary

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

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2008

Geographic Reach
2 countries

12 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 6, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 7, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

March 6, 2012

Completed
Last Updated

March 6, 2012

Status Verified

February 1, 2012

Enrollment Period

2.4 years

First QC Date

October 6, 2008

Results QC Date

February 2, 2012

Last Update Submit

February 2, 2012

Conditions

Diabetic Macular Edema

Keywords

DiabetesMacular edemaAliskirenDiabetic retinopathyDiabetes mellitus type 1Diabetes mellitus type 2

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Aliskiren 300 mg

EXPERIMENTAL

Aliskiren 300 mg once daily for 12 weeks

Drug: Aliskiren

Placebo

PLACEBO COMPARATOR

Matching placebo once daily for 12 weeks

Drug: Placebo

Interventions

AliskirenDRUG

300 mg once daily

Also known as: SPP100
Aliskiren 300 mg
PlaceboDRUG

Matching placebo once daily

Placebo

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 or type 2 diabetes
  • Diabetic macular edema

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Retinal Consultants of Arizona

Phoenix, Arizona, United States

Location

Retina-Vitreous Associates

Los Angeles, California, United States

Location

National Ophthalmic Research Institute

Fort Myers, Florida, United States

Location

Georgia Retina

Atlanta, Georgia, United States

Location

Elman Retina Group

Baltimore, Maryland, United States

Location

Joslin Clinic

Boston, Massachusetts, MA, United States

Location

Vitreo-Retinal Associates

Grand Rapids, Michigan, United States

Location

Charlotte Eye, Ear, Nose and Throat Associate

Charlotte, North Carolina, NC, United States

Location

Retina-Associates of Cleveland, Inc

Beachwood, Ohio, United States

Location

Retinal Consultants of Houston

Houston, Texas, TX, United States

Location

Novartis Investigative Site

Aarhus, Denmark

Location

Novartis Investigative Site

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Diabetes MellitusMacular EdemaDiabetic RetinopathyDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Interventions

aliskiren

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesMacular DegenerationRetinal DegenerationRetinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsAutoimmune DiseasesImmune System Diseases

Limitations and Caveats

This study was terminated early due to low recruitment of patients. The study lacked power against the original objective of statistically significance for changes in central retinal thickness due to the much reduced sample size.

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
862-778-8300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2008

First Posted

October 7, 2008

Study Start

September 1, 2008

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

March 6, 2012

Results First Posted

March 6, 2012

Record last verified: 2012-02

Locations

DK(2)US(10)