Effect of Ruboxistaurin on Clinically Significant Macular Edema
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|ClinicalTrials.gov Identifier: NCT00133952|
Recruitment Status : Completed
First Posted : August 24, 2005
Results First Posted : January 28, 2016
Last Update Posted : October 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Macular Edema||Drug: Ruboxistaurin Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||309 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||The Effect of Ruboxistaurin on Vision Loss in Patients With Diabetes Mellitus and Clinically Significant Macular Edema|
|Study Start Date :||August 2005|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||July 2011|
32 mg taken orally daily for up to 48 months
Other Name: LY333531
Placebo Comparator: Placebo
Taken orally daily for up to 48 months
- Percentage of Participants With Sustained Moderate Visual Loss (SMVL) Any Time Baseline Through Month 48 [ Time Frame: Baseline through 48 months ]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).
- Change From Baseline to Month 24 in Mean Retinal Thickness Within 500 Microns of the Center of the Macula [ Time Frame: Baseline, 24 months ]Least Squares (LS) Mean values were controlled for treatment, pooled center, and baseline value.
- Number of Eyes With Significant Center-Involved Macular Edema at Any Time From Baseline Through Month 24 [ Time Frame: Baseline through 24 months ]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 to Focal Photocoagulation [ Time Frame: Baseline through 48 months ]
- Change From Baseline to Month 24 in Contrast Sensitivity [ Time Frame: Baseline, 24 months ]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.
- 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 [ Time Frame: Baseline through 24 months ]Repeat focal photocoagulation is defined as 2 or more focal photocoagulation treatments needed during the study.
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): NCT00133952
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|Study Director:||Karl Beutner||Chromaderm, Inc.|