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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chromaderm, Inc.
ClinicalTrials.gov Identifier:
NCT00604383
First received: January 17, 2008
Last updated: July 25, 2016
Last verified: July 2016
  Purpose
This study is to test whether or not 32 milligrams (mg) of ruboxistaurin a day over three years will reduce vision loss associated with diabetic retinopathy.

Condition Intervention Phase
Diabetic Retinopathy
Drug: ruboxistaurin
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 Chromaderm, Inc.:

Primary Outcome Measures:
  • Percentage of Participants Who Had Sustained Moderate Visual Loss (SMVL) as Defined as a Visual Acuity Loss of ≥15 Letters Measured Twice During a 6-month Period [ Time Frame: Baseline through 36 months ] [ Designated as safety issue: No ]
    SMVL is defined as a ≥15-letter decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) that the participant sustained during the last 6 months of study participation (Months 30-36). Participants who discontinued the study early may have had SMVL if there was a 6-month period of ≥15 letters lost in VA ending with the last visit at which VA was assessed. ETDRS visual acuity uses an eye chart with 5 letters per line. The scores range from 0 (no letters read correctly) to 100 (all letters read correctly). Percentage of participants = (number of participants who had SMVL) / (number of participants who were randomized) * 100.


Secondary Outcome Measures:
  • Percentage of Participants Who Developed Center Involved or Imminently Threatened Diabetic Macular Edema (DME) [ Time Frame: Baseline through 36 months ] [ Designated as safety issue: No ]
    DME is the accumulation of extracellular fluid in the retinal tissue of the macular area, which can reduce the ability for fine visual discrimination. Percentage of participants = (number of participants who developed center involved or imminently threatened DME) / (number of participants who had no center involved or imminently threatened DME at baseline) * 100.

  • Percentage of Participants Who Experienced the Development of Proliferative Diabetic Retinopathy (PDR) [ Time Frame: Baseline through 36 months ] [ Designated as safety issue: No ]
    Percentage of participants = (number of participants who experienced the development of PDR) / (number of participants who were randomized) * 100.

  • Change From Baseline up to 36 Months in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) [ Time Frame: Baseline, up to 36 months ] [ Designated as safety issue: No ]
    NEI-VFQ-25 consisted of 25 questions and was used to measure the influence of visual disability and symptoms on general health of participants. The possible total score range for the NEI-VFQ-25 was from 0 (worst possible outcome) to 100 (best possible outcome).

  • Change From Baseline up to 36 Months in Mental and Physical Components of the Medical Outcomes Study 36-Item Short Form (SF-36) Health Status Questionnaire [ Time Frame: Baseline, up to 36 months ] [ Designated as safety issue: No ]
    SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions. There are 2 component scores, mental component score (MCS) and physical component score (PCS). MCS score consisted of social functioning, vitality, mental health, and role-emotional scales. PCS score consisted of physical functioning, bodily pain, role-physical, and general health scales. Both MCS and PCS have scores ranging from 0 to 100 with higher scores indicating better mental or physical health.


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: Ruboxistaurin Drug: ruboxistaurin
32-mg tablet, orally, daily, up to 42 months
Other Name: LY333531
Placebo Comparator: Placebo Drug: placebo
1 tablet, orally, daily, up to 42 months

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  • Hemoglobin A1c (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 laboratory measurements that could represent 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
Chromaderm, Inc.
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chromaderm, Inc.
ClinicalTrials.gov Identifier: NCT00604383     History of Changes
Other Study ID Numbers: 4743  B7A-MC-MBCM 
Study First Received: January 17, 2008
Results First Received: December 22, 2015
Last Updated: July 25, 2016
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 27, 2016