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Trial record 6 of 11 for:    pkc diabetes

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

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ClinicalTrials.gov Identifier: NCT00604383
Recruitment Status : Completed
First Posted : January 30, 2008
Results First Posted : January 28, 2016
Last Update Posted : October 6, 2016
Sponsor:
Information provided by (Responsible Party):
Chromaderm, Inc.

Tracking Information
First Submitted Date  ICMJE January 17, 2008
First Posted Date  ICMJE January 30, 2008
Results First Submitted Date  ICMJE December 22, 2015
Results First Posted Date  ICMJE January 28, 2016
Last Update Posted Date October 6, 2016
Study Start Date  ICMJE March 2001
Actual Primary Completion Date June 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 17, 2008)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2015)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2008)
Secondary efficacy measures were evaluated using a gatekeeping strategy. Safety was also assessed. [ Time Frame: 3 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Protein Kinase C (PKC) Inhibitor-Diabetic Retinopathy Phase 3 Study
Official Title  ICMJE 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.
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Retinopathy
Intervention  ICMJE
  • Drug: ruboxistaurin
    32-mg tablet, orally, daily, up to 42 months
    Other Name: LY333531
  • Drug: placebo
    1 tablet, orally, daily, up to 42 months
Study Arms  ICMJE
  • Experimental: Ruboxistaurin
    Intervention: Drug: ruboxistaurin
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
Publications * Davis MD, Sheetz MJ, Aiello LP, Milton RC, Danis RP, Zhi X, Girach A, Jimenez MC, Vignati L; PKC-DRS2 Study Group. Effect of ruboxistaurin on the visual acuity decline associated with long-standing diabetic macular edema. Invest Ophthalmol Vis Sci. 2009 Jan;50(1):1-4. doi: 10.1167/iovs.08-2473. Epub 2008 Aug 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 17, 2008)
685
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2005
Actual Primary Completion Date June 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00604383
Other Study ID Numbers  ICMJE 4743
B7A-MC-MBCM ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chromaderm, Inc.
Study Sponsor  ICMJE Chromaderm, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Karl Beutner Chromaderm, Inc.
PRS Account Chromaderm, Inc.
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP