Phase 3
Completed N=731
Reduction in the Occurrence of Center-Involved Diabetic Macular Edema
Source: ClinicalTrials.gov NCT00090519 ↗Enrolled (actual)
731
Serious AEs
23.9%
Results posted
May 2016
Primary outcomePrimary: Mean Duration of Definite Center of Macula-involved Diabetic Macular Edema (DME) — 1.72; 1.69 months per participant — p=0.969
◆ Published Evidence
Established
61citations · ~5 / year
The effect of the oral PKC β inhibitor ruboxistaurin on vision loss in two phase 3 studies.
Summary
The purpose of this study is to determine if ruboxistaurin can help slow the worsening of an eye disease called macular edema in patients with diabetes.
Linked Publications
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The effect of the oral PKC β inhibitor ruboxistaurin on vision loss in two phase 3 studies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Duration of Definite Center of Macula-involved Diabetic Macular Edema (DME) |
1.72; 1.69 | 0.969 |
| PRIMARY Occurrence of Sustained Moderate Visual Loss (SMVL) in a Diabetic Retinopathy (DR) Study Eye |
8; 16; 334; 315 | 0.081 |
| SECONDARY Change From Baseline in Visual Acuity by Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) Chart at 36 Months |
84.12; 84.27; -1.14; -2.30 | 0.015 sig |
| SECONDARY First Occurrence of Focal/Grid Photocoagulation |
32; 27; 339; 333 | 0.577 |
| SECONDARY Change From Baseline in Contrast Sensitivity by Pelli-Robson |
33.54; 33.71; -0.54; -1.06 | 0.041 sig |
| SECONDARY Progression of Nonproliferative Diabetic Retinopathy (DR) by Seven-field Stereo Fundus Photography |
328; 312; 43; 48 | 0.475 |
| SECONDARY Change From Baseline in Estimated Glomerular Filtration Rate |
85.35; 87.27; -5.55; -7.92 | 0.211 |
| SECONDARY Change From Baseline at Endpoint in Albumin/Creatinine Ratio |
123.53; 152.61; 135.90; 72.69 | 0.365 |
| SECONDARY Change From Baseline at Endpoint in Visual Function by the National Eye Institute Visual Functioning Questionnaire (NEI VFQ-25) at 36 Months |
67.86; 67.56; 0.17; -1.36 | 0.009 sig |
| SECONDARY Number of Participants With Adverse Events |
93; 82; 298; 299 | — |
Eligibility Criteria
Inclusion Criteria
- Type 1 or Type 2 diabetes
- 18 years or older
- Non-clinically significant diabetic macular edema
- Mild to moderate diabetic retinopathy in the study eye, vitreous hemorrhage in the study eye
- Relatively good vision (20/30 or better)
Exclusion Criteria
- Surgery or laser treatment in the study eye
- Glaucoma in the study eye
- Glycosylated hemoglobin (HbA1c) greater than 11%, or systolic blood pressure greater than 170 millimeters of mercury (mmHg)
- Liver disease, dialysis or renal transplant
Data sourced from ClinicalTrials.gov (NCT00090519) and the linked publication. 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.