Phase 3
Completed N=685
Protein Kinase C (PKC) Inhibitor-Diabetic Retinopathy Phase 3 Study
Source: ClinicalTrials.gov NCT00604383 ↗Enrolled (actual)
685
Serious AEs
44.1%
Results posted
Jan 2016
Primary outcomePrimary: 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 — 5.5; 9.1 percentage of participants — p=0.034
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
5.5; 9.1 | 0.034 sig |
| SECONDARY Percentage of Participants Who Developed Center Involved or Imminently Threatened Diabetic Macular Edema (DME) |
44.4; 49.0 | — |
| SECONDARY Percentage of Participants Who Experienced the Development of Proliferative Diabetic Retinopathy (PDR) |
35.9; 36.5 | — |
| SECONDARY Change From Baseline up to 36 Months in the National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) |
-3.82; -4.10 | — |
| SECONDARY Change From Baseline up to 36 Months in Mental and Physical Components of the Medical Outcomes Study 36-Item Short Form (SF-36) Health Status Questionnaire |
-12.21; -19.85; -30.63; -29.15 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00604383). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.