Back to resultsProtein Kinase C (PKC) Inhibitor-Diabetic Retinopathy Phase 3 Study
Primary Purpose
Diabetic Retinopathy
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ruboxistaurin
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Retinopathy
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
- 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
Sites / Locations
- 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.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ruboxistaurin
Placebo
Arm Description
Outcomes
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
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)
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)
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)
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00604383
Brief Title
Protein Kinase C (PKC) Inhibitor-Diabetic Retinopathy Phase 3 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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chromaderm, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Retinopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
685 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ruboxistaurin
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ruboxistaurin
Other Intervention Name(s)
LY333531
Intervention Description
32-mg tablet, orally, daily, up to 42 months
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
1 tablet, orally, daily, up to 42 months
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline through 36 months
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Developed Center Involved or Imminently Threatened Diabetic Macular Edema (DME)
Description
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.
Time Frame
Baseline through 36 months
Title
Percentage of Participants Who Experienced the Development of Proliferative Diabetic Retinopathy (PDR)
Description
Percentage of participants = (number of participants who experienced the development of PDR) / (number of participants who were randomized) * 100.
Time Frame
Baseline through 36 months
Title
Change From Baseline up to 36 Months in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25)
Description
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).
Time Frame
Baseline, up to 36 months
Title
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
Description
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.
Time Frame
Baseline, up to 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl Beutner
Organizational Affiliation
Chromaderm, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Indianapolis
State/Province
Indiana
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18708615
Citation
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.
Results Reference
derived
Learn more about this trial
Protein Kinase C (PKC) Inhibitor-Diabetic Retinopathy Phase 3 Study
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