Protein Kinase C (PKC) Inhibitor-Diabetic Retinopathy Phase 3 Study (NCT00604383) | Clinical Trial Compass
CompletedPhase 3
Protein Kinase C (PKC) Inhibitor-Diabetic Retinopathy Phase 3 Study
United States685 participantsStarted 2001-03
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
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