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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00604383
First Posted: January 30, 2008
Last Update Posted: October 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Chromaderm, Inc.
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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: Karl Beutner Chromaderm, Inc.
  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 ( Other Identifier: Eli Lilly and Company )
First Submitted: January 17, 2008
First Posted: January 30, 2008
Results First Submitted: December 22, 2015
Results First Posted: January 28, 2016
Last Update Posted: October 6, 2016
Last Verified: August 2016

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