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
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Retinopathy||Drug: ruboxistaurin Drug: placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||685 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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 Start Date :||March 2001|
|Actual Primary Completion Date :||June 2005|
|Actual Study Completion Date :||June 2005|
32-mg tablet, orally, daily, up to 42 months
Other Name: LY333531
|Placebo Comparator: Placebo||
1 tablet, orally, daily, up to 42 months
- 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.
- 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.
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
|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|
|Study Director:||Karl Beutner||Chromaderm, Inc.|