Protein Kinase C (PKC) Inhibitor-Diabetic Retinopathy Phase 3 Study - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00604383

Purpose

This study is to test whether or not 32mg of ruboxistaurin a day over three years will reduce vision loss associated with diabetic retinopathy.

Condition	Intervention	Phase
Diabetic Retinopathy	Drug: ruboxistaurin mesylate Drug: placebo	Phase III

MedlinePlus related topics: Diabetes Diabetic Eye Problems Retinal Disorders

Drug Information available for: Ruboxistaurin

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase 3, Multicenter,Parallel,Randomized Dbl-Masked,Placebo-Controlled Study of the Effects of 32 mg/dy Ruboxistaurin Vision Loss in Patients With Type 1 or Type 2 Diabetes Mellitus and an Early Treatment Diabetic Retinopathy Study Level Between 47A and 53E.

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Occurrence of Sustained Moderate Visual Loss (SMVL) as defined as a visual acuity loss of >= 15 letters measured twice during a 6 month period. [ Time Frame: 3 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Secondary efficacy measures were evaluated using a gatekeeping strategy. Safety was also assessed. [ Time Frame: 3 year ] [ Designated as safety issue: No ]

Enrollment:	685
Study Start Date:	March 2001
Study Completion Date:	June 2005
Primary Completion Date:	June 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Ruboxistaurin	Drug: ruboxistaurin mesylate 32mg tablet, oral, daily, 3 years
2: Placebo Comparator	Drug: placebo 1 tab, oral, daily, 3 years

Eligibility

Criteria

Inclusion Criteria:

Type 1 or Type 2 diabetes mellitus
18 years or older
Meet specific requirements for diabetic retinopathy
Free of severe or chronically disabling conditions, except diabetes, diabetic retinopathy and diabetic macular edema
HbA1C <= 13.0%

Exclusion Criteria:

History of panretinal photocoagulation for diabetic retinopathy, conditions that might affect the progression of diabetic retinopathy, or unstable angina
Investigators, site personnel directly affiliated with the study and their families
Presence of eye disorders that may affect the progression of diabetic retinopathy or cause vision loss
Presence of medical disorder, cancer, or elevated measurements that could pose a safety risk during the study
Women who are pregnant, breastfeeding, intend to become pregnant, or who are sexually active without using an acceptable method of birth control

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00604383

Locations

United States, Indiana
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT -5 hours, EST) or speak with your personal physician.
Indianapolis, Indiana, United States

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

Call 1-877-CTLILLY (1-877-285-4559) or 317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

More Information

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

Publications indexed to this study:

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	4743, B7A-MC-MBCM
Study First Received:	January 17, 2008
Last Updated:	January 17, 2008
ClinicalTrials.gov Identifier:	NCT00604383
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Diabetic Retinopathy
Ruboxistaurin
Eye Diseases
Diabetes Mellitus, Type 2
Vascular Diseases
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Blindness
Diabetes Complications
Retinal Diseases
Diabetic Angiopathies

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009