Phase 3
N=309
Effect of Ruboxistaurin on Clinically Significant Macular Edema
Diabetic Macular Edema
Bottom Line
View on ClinicalTrials.gov: NCT00133952 ↗Enrolled (actual)
309
Serious AEs
22.2%
Results posted
Jan 2016
Primary outcome: Primary: Percentage of Participants With Sustained Moderate Visual Loss (SMVL) Any Time Baseline Through Month 48 — 3.4; 2.2 percent of participants — p=0.724
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ruboxistaurin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Chromaderm, Inc.
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Moderate Visual Loss (SMVL) Any Time Baseline Through Month 48 |
3.4; 2.2 | 0.724 |
| SECONDARY Change From Baseline to Month 24 in Mean Retinal Thickness Within 500 Microns of the Center of the Macula |
12.8; 9.4 | 0.616 |
| SECONDARY Number of Eyes With Significant Center-Involved Macular Edema at Any Time From Baseline Through Month 24 |
77; 76 | 0.971 |
| SECONDARY Time to Focal Photocoagulation |
NA; NA | — |
| SECONDARY Change From Baseline to Month 24 in Contrast Sensitivity |
-1.1; -0.6 | 0.344 |
| SECONDARY Change From Baseline to Month 24 in Retinal Thickness at the Center of the Macula |
10.5; 13.1 | 0.663 |
| SECONDARY Number of Participants Requiring Focal Photocoagulation at Any Time From Baseline Through Month 24 |
35; 26 | 0.203 |
| SECONDARY Number of Participants Not Requiring Focal Photocoagulation at Any Time From Baseline Through Month 24 |
113; 123 | — |
| SECONDARY Number of Participants Requiring Repeat Focal Photocoagulation at Any Time From Baseline Though Month 24 |
11; 12 | 0.749 |
Summary
The purpose of the study is to test the hypothesis that oral administration of ruboxistaurin will reduce the occurrence of sustained moderate visual loss (SMVL) in patients with clinically significant macular edema. SMVL is defined as a 15 letter or more decrease from baseline in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity that is sustained for the patient's last 6 months of study participation. The SMVL data from this study will be combined with the SMVL data from Study B7A-MC-MBDL for the purpose of comparing ruboxistaurin to placebo.
Eligibility Criteria
Inclusion Criteria
- Type 1 or 2 diabetes
- 18 years or older
- Hemoglobin A1c (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.
Data sourced from ClinicalTrials.gov (NCT00133952). 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.