Protein Kinase C (PKC) Inhibitor-Diabetic Retinopathy Phase 3 Study
| Status: | Completed |
|---|---|
| Conditions: | Ocular, Diabetes |
| Therapuetic Areas: | Endocrinology, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | March 2001 |
| End Date: | June 2005 |
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.
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.
years will reduce vision loss associated with diabetic retinopathy.
Inclusion Criteria:
- Type 1 or Type 2 diabetes mellitus
- 18 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%
Exclusion Criteria:
- 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
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