Protein Kinase C (PKC) Inhibitor-Diabetic Retinopathy Phase 3 Study
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.
2 other identifiers
interventional
685
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2001
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 17, 2008
CompletedFirst Posted
Study publicly available on registry
January 30, 2008
CompletedResults Posted
Study results publicly available
January 28, 2016
CompletedOctober 6, 2016
August 1, 2016
4.3 years
January 17, 2008
December 22, 2015
August 25, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline through 36 months
Secondary Outcomes (4)
Percentage of Participants Who Developed Center Involved or Imminently Threatened Diabetic Macular Edema (DME)
Baseline through 36 months
Percentage of Participants Who Experienced the Development of Proliferative Diabetic Retinopathy (PDR)
Baseline through 36 months
Change From Baseline up to 36 Months in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25)
Baseline, up to 36 months
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
Baseline, up to 36 months
Study Arms (2)
Ruboxistaurin
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Type 1 or Type 2 diabetes mellitus
- 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%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Chromaderm, Inc.lead
Study Sites (1)
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
Related Publications (1)
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.
PMID: 18708615DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- info@chroma-derm.com
- Organization
- Chromaderm
Study Officials
- STUDY DIRECTOR
Karl Beutner
Chromaderm, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 17, 2008
First Posted
January 30, 2008
Study Start
March 1, 2001
Primary Completion
June 1, 2005
Study Completion
June 1, 2005
Last Updated
October 6, 2016
Results First Posted
January 28, 2016
Record last verified: 2016-08