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

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetic Retinopathy

In brief

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.

Key facts

Study ID

NCT00604383

Run by

Chromaderm, Inc.

People needed

685

Starts

2001-03-01

Expected to finish

2005-06-01

Last updated by the study team

2016-10-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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

Where it is running

• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT -5 hours, EST) or speak with your personal physician. — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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