Status:
COMPLETED
Effect of Ruboxistaurin on Clinically Significant Macular Edema
Lead Sponsor:
Chromaderm, Inc.
Conditions:
Diabetic Macular Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to test the hypothesis that oral administration of ruboxistaurin will reduce the occurrence of sustained moderate visual loss (SMVL) in patients with clinically significant...
Eligibility Criteria
Inclusion
- Type 1 or 2 diabetes
- 18 years or older
- Hemoglobin A1c (HbA1c) less than or equal to 11%
- Mild to very severe non-proliferative diabetic retinopathy in the study eye
- Clinically significant macular edema in the study eye not within 100 microns of center of macula
Exclusion
- Previous surgery or laser treatment (or need for laser treatment within 3 months) in the study eye
- Glaucoma in the study eye
- Unstable cardiovascular disease
- Major surgery within past 3 months
- Significantly impaired kidney or liver function, or malignancy requiring chemotherapy or radiation therapy.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
309 Patients enrolled
Trial Details
Trial ID
NCT00133952
Start Date
August 1 2005
End Date
July 1 2011
Last Update
October 6 2016
Active Locations (41)
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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.
Phoenix, Arizona, United States, 85020
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.
Artesia, California, United States, 90701
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.
Newark, Delaware, United States, 19713
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.
Jacksonville, Florida, United States, 32204