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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00604383
First received: January 17, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


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
Experimental: 1
Ruboxistaurin
Drug: ruboxistaurin mesylate
32mg tablet, oral, daily, 3 years
Other Name: LY333351
Placebo Comparator: 2 Drug: placebo
1 tab, oral, daily, 3 years

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00604383     History of Changes
Other Study ID Numbers: 4743, B7A-MC-MBCM
Study First Received: January 17, 2008
Last Updated: January 17, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Diabetic Angiopathies
Endocrine System Diseases
Eye Diseases
Vascular Diseases
Ruboxistaurin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 25, 2014