Treatment for Completers of the Study B7A-MC-MBCM

Chromaderm

Status and phase: Completed; Phase 3

Conditions: Diabetic Retinopathy

Treatments: Drug: Ruboxistaurin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00266695

10699 (Registry Identifier)

B7A-MC-MBDV (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 203 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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203 participants in 1 patient group

Ruboxistaurin

Experimental group

Treatment:

Drug: Ruboxistaurin