Reduction in the Occurrence of Center-Involved Diabetic Macular Edema

Chromaderm

Status and phase: Completed; Phase 3

Conditions: Diabetic Retinopathy

Treatments: Drug: placebo; Drug: ruboxistaurin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00090519

8211

B7A-MC-MBDL (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 731 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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731 participants in 2 patient groups, including a placebo group

Ruboxistaurin

Experimental group

Description:

32 milligrams (mg) once daily (QD) oral for up to 36 months

Treatment:

Drug: ruboxistaurin

Placebo

Placebo Comparator group

Description:

QD oral for up to 36 months

Treatment:

Drug: placebo