Reduction in the Occurrence of Center-Involved Diabetic Macular Edema
Completed
Chromaderm, Inc.
Phase 3
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.
Effect of Ruboxistaurin on Clinically Significant Macular Edema
Completed
Chromaderm, Inc.
Phase 3
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.
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.
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