Phase 3
Completed N=203
Treatment for Completers of the Study B7A-MC-MBCM
Source: ClinicalTrials.gov NCT00266695 ↗Enrolled (actual)
203
Serious AEs
28.1%
Results posted
Jan 2016
Primary outcomePrimary: Sustained Moderate Visual Loss (SMVL) — 10 participants
Summary
To provide ruboxistaurin treatment to patients who completed the B7A-MC-MBCM study (NCT00604383), and who are felt by the investigator to have the potential to benefit from the ruboxistaurin treatment. Patients must be off study drug for 6 to 18 months from completion of B7A-MC-MBCM before beginning B7A-MC-MBDV. Additional data will be gathered to determine the long-term safety and effect of ruboxistaurin on vision.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sustained Moderate Visual Loss (SMVL) |
10 | — |
| SECONDARY Vision Loss |
22 | — |
| SECONDARY Sustained Moderate Vision Loss (SMVL), Long Term |
8 | — |
| SECONDARY Number of Participants With a Modified Sustained Moderate Vision Loss (mSMVL) Event by Time Interval |
0; 4; 5; 2; 0 | — |
| SECONDARY Visual Acuity |
75.14 | — |
| SECONDARY Number of Participants Receiving Treatment With Focal/Grid Photocoagulation |
19 | — |
| SECONDARY Number of Participants Receiving Treatment With Panretinal Photocoagulation |
53 | — |
Eligibility Criteria
Inclusion Criteria
- Patients that completed Month 36 (Visit 15) of the study B7A-MC-MBCM, and the investigator believes he/she would benefit from ruboxistaurin treatment.
Exclusion Criteria
- Patients that discontinued from the study B7A-MC-MBCM and/or the investigator does not believe he/she would benefit from ruboxistaurin treatment.
Data sourced from ClinicalTrials.gov (NCT00266695). 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.