Status:
COMPLETED
Reduction in the Occurrence of Center-Involved Diabetic Macular Edema
Lead Sponsor:
Chromaderm, Inc.
Conditions:
Diabetic Retinopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
731 Patients enrolled
Trial Details
Trial ID
NCT00090519
Start Date
February 1 2004
End Date
April 1 2010
Last Update
October 6 2016
Active Locations (84)
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1
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.
Artesia, California, United States, 90701
2
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.
Palm Springs, California, United States, 92262
3
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.
Poway, California, United States, 92064
4
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.
Walnut Creek, California, United States, 94598