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Sponsored by: |
iCo Therapeutics Inc. |
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Information provided by: | iCo Therapeutics Inc. |
ClinicalTrials.gov Identifier: | NCT00886808 |
The goal of the study is to evaluate the safety and tolerability of 4 different doses of iCo-007 Intravitreal Injection in patients with diffuse diabetic macular edema.
Condition | Intervention | Phase |
---|---|---|
Diffuse Diabetic Macular Edema |
Drug: iCo-007 Intravitreal Injection |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety Study |
Official Title: | A Phase I, Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of iCo-007 Intravitreal Injection in Subjects With Diffuse Diabetic Macular Edema |
Estimated Enrollment: | 15 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
110 microgram dose of iCo-007 Intravitreal Injection
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Drug: iCo-007 Intravitreal Injection
single dose iCo-007 Intravitreal Injection
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2: Experimental
350microgram dose of iCo-007 Intravitreal Injection
|
Drug: iCo-007 Intravitreal Injection
single dose iCo-007 Intravitreal Injection
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3: Experimental
700microgram dose of iCo-007 Intravitreal Injection
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Drug: iCo-007 Intravitreal Injection
single dose iCo-007 Intravitreal Injection
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4: Experimental
1,000microgram dose of iCo-007 Intravitreal Injection
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Drug: iCo-007 Intravitreal Injection
single dose iCo-007 Intravitreal Injection
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Nidia Rosado | (919) 668-7817 | nidia.rosado@duke.edu |
Contact: Thomas Barfield | (919) 668-7031 | thomas.barfield@duke.edu |
United States, California | |
Retina-Vitreous Associates Medical Group | Recruiting |
Los Angeles, California, United States | |
Contact: Charles Yoon 310-289-2478 ext 112 | |
United States, Florida | |
Bascom Palmer Eye Institute | Recruiting |
Miami, Florida, United States | |
Contact: Maria Esquiabro 305-326-6508 | |
United States, North Carolina | |
Duke Eye Center | Recruiting |
Durham, North Carolina, United States | |
Contact: Noreen McClain 919-684-0558 | |
United States, Texas | |
Valley Retina Institute | Recruiting |
McAllen, Texas, United States | |
Contact: Aaron Guel 956-631-8875 |
Responsible Party: | iCo Therapeutics Inc. ( Peter Hnik, MD ) |
Study ID Numbers: | 2006-007-01-DME |
Study First Received: | April 22, 2009 |
Last Updated: | April 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00886808 History of Changes |
Health Authority: | United States: Food and Drug Administration |
DME, Diabetic Retinopathy, Diabetic Macular Edema |
Signs and Symptoms Macular Edema Diabetic Retinopathy Eye Diseases |
Retinal Degeneration Macular Degeneration Edema Retinal Diseases |
Signs and Symptoms Macular Edema Eye Diseases Retinal Degeneration |
Macular Degeneration Edema Retinal Diseases |