| August 22, 2005 |
| July 30, 2009 |
| August 2005 |
| December 2010 (final data collection date for primary outcome measure) |
| Central macular thickness by OCT. [ Time Frame: 24 months ] [ Designated as safety issue: No ] |
| - Change from baseline to endpoint in absolute retinal thickness at the center of the macula, as determined by OCT. |
| Complete list of historical versions of study NCT00133952 on ClinicalTrials.gov Archive Site |
- Occurrence of sustained moderate visual loss (SMVL) as assessed by best correctred ETDRS visual acuity. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Mean retinal thickness by OCT [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Occurrence of significant center-involved macular edema, as assessed by OCT [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Photocoagulation [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Contrast sensitivity using the Pelli-Robson chart [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- Macular edema volume measures [ Time Frame: 24 months ] [ Designated as safety issue: No ]
|
- - Change from baseline to endpoint in visual acuity.
- - Change from baseline to endpoint in mean retinal thickness, as assessed by OCT.
- - Occurrence of significant center-involved macular edema, as assessed by OCT.
- - Occurrence of other measures or treatments of diabetic macular edema or visual function.
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| |
| Effect of Ruboxistaurin on Clinically Significant Macular Edema |
| Effect of Ruboxistaurin on Clinically Significant Macular Edema in Patients With Diabetes Mellitus, as Assessed by Optical Coherence Tomography |
The purpose of the study is to test the hypothesis that oral administration of ruboxistaurin for approximately 24 months will reduce the baseline to endpoint changes in macular thickness, as measured by optical coherence tomography (OCT), in patients with clinically significant macular edema. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Diabetic Macular Edema |
- Drug: ruboxistaurin
- Drug: Placebo
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| |
| |
| |
| Active, not recruiting |
| 300 |
| December 2010 |
| December 2010 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Type 1 or 2 diabetes
- 18 years or older
- HbA1c less than or equal to 11%
- Mild to very severe non-proliferative diabetic retinopathy in the study eye
- Clinically significant macular edema in the study eye not within 100 microns of center of macula
Exclusion Criteria:
- Previous surgery or laser treatment (or need for laser treatment within 3 months) in the study eye
- Glaucoma in the study eye
- Unstable cardiovascular disease
- Major surgery within past 3 months
- Significantly impaired kidney or liver function, or malignancy requiring chemotherapy or radiation therapy.
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| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Canada, Denmark, Germany, Lithuania, Mexico, Portugal, Romania, Spain, United Kingdom |
| |
| NCT00133952 |
| Chief Medical Officer, Eli Lilly |
| 5882, B7A-MC-MBCU |
| Eli Lilly and Company |
|
| Study Director: |
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM to 5 PM Eastern Time (UTC/GMT- 5 hours, EST) |
Eli Lilly and Company |
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|
| Eli Lilly and Company |
| July 2009 |
