Protein Kinase C (PKC) Inhibitor-Diabetic Retinopathy Phase 3 Study

Chromaderm

Status and phase: Completed; Phase 3

Conditions: Diabetic Retinopathy

Treatments: Drug: ruboxistaurin; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00604383

B7A-MC-MBCM (Other Identifier)

4743

Details and patient eligibility

About

This study is to test whether or not 32 milligrams (mg) of ruboxistaurin a day over three years will reduce vision loss associated with diabetic retinopathy.

Enrollment: 685 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 or Type 2 diabetes mellitus
• 18 years or older
• Meet specific requirements for diabetic retinopathy
• Free of severe or chronically disabling conditions, except diabetes, diabetic retinopathy and diabetic macular edema
• Hemoglobin A1c (HbA1C) ≤13.0%

Exclusion criteria

• History of panretinal photocoagulation for diabetic retinopathy, conditions that might affect the progression of diabetic retinopathy, or unstable angina
• Investigators, site personnel directly affiliated with the study and their families
• Presence of eye disorders that may affect the progression of diabetic retinopathy or cause vision loss
• Presence of medical disorder, cancer, or elevated laboratory measurements that could represent a safety risk during the study
• Women who are pregnant, breastfeeding, intend to become pregnant, or who are sexually active without using an acceptable method of birth control

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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685 participants in 2 patient groups, including a placebo group

Ruboxistaurin

Experimental group

Treatment:

Drug: ruboxistaurin

Placebo

Placebo Comparator group

Treatment:

Drug: placebo