The purpose of the study is to test the hypothesis that oral administration of ruboxistaurin will reduce the occurrence of sustained moderate visual loss (SMVL) in patients with clinically significant macular edema. SMVL is defined as a 15 letter or more decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity that is sustained for the patient's last 6 months of study participation. The SMVL data from this study will be combined with the SMVL data from Study B7A-MC-MBDL for the purpose of comparing ruboxistaurin to placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
309
Administered orally
Administered orally
Percentage of Participants With Sustained Moderate Visual Loss (SMVL) Any Time Baseline Through Month 48
SMVL is defined as a 15 letter or more decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity that is sustained for the participant's last 6 months of study participation. 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).
Time frame: Baseline through 48 months
Change From Baseline to Month 24 in Mean Retinal Thickness Within 500 Microns of the Center of the Macula
Least Squares (LS) Mean values were controlled for treatment, pooled center, and baseline value.
Time frame: Baseline, 24 months
Number of Eyes With Significant Center-Involved Macular Edema at Any Time From Baseline Through Month 24
Significant center-involved macular edema is defined as an absolute retinal thickness at the center of the macula \>2 standard deviations above the mean baseline value (where the mean and standard deviation are calculated at baseline from the randomized population of participants with retinal thickness values of ≤ 300 microns in depth).
Time frame: Baseline through 24 months
Time to Focal Photocoagulation
Time frame: Baseline through 48 months
Change From Baseline to Month 24 in Contrast Sensitivity
Values are presented as changes in the number of letters read correctly on the Pelli-Robson contrast sensitivity chart which consists of 16 triplets (48 letters total) with letters of the same size but decreasing contrast. Least Squares (LS) Mean values were controlled for treatment, pooled center, and baseline value.
Time frame: Baseline, 24 months
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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.
Phoenix, Arizona, United States
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Artesia, California, United States
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Newark, Delaware, United States
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Jacksonville, Florida, United States
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Augusta, Georgia, United States
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Indianapolis, Indiana, United States
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Baltimore, Maryland, United States
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Boston, Massachusetts, United States
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.
Grand Rapids, Michigan, United States
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.
Portsmouth, New Hampshire, United States
...and 31 more locations
Change From Baseline to Month 24 in Retinal Thickness at the Center of the Macula
Time frame: Baseline, up to 24 months
Number of Participants Requiring Focal Photocoagulation at Any Time From Baseline Through Month 24
Time frame: Baseline through 24 months
Number of Participants Not Requiring Focal Photocoagulation at Any Time From Baseline Through Month 24
Time frame: Baseline through 24 months
Number of Participants Requiring Repeat Focal Photocoagulation at Any Time From Baseline Though Month 24
Repeat focal photocoagulation is defined as 2 or more focal photocoagulation treatments needed during the study.
Time frame: Baseline through 24 months