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| Sponsor: | Jerini Ophthalmic |
|---|---|
| Information provided by: | Jerini Ophthalmic |
| ClinicalTrials.gov Identifier: | NCT00536016 |
Purpose
The purpose of this study is to determine the way and rate that the study medication, JSM6427 a potent, highly specific integrin α5β1-antagonist is absorbed, broken-down and eliminated from the body when it is given as a single dosage strength by injection into the eye. Repeated dosages will also be given to determine the highest safe dose.
| Condition | Intervention | Phase |
|---|---|---|
|
Macular Degeneration |
Drug: JSM6427 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1 Open Label Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of Single and Repeated Doses of JSM6427 Following Administration by Intravitreal Injection in Patients With Neovascular AMD |
| Estimated Enrollment: | 36 |
| Study Start Date: | September 2007 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
In non-clinical models, JSM6427 can lead to the inhibition and regression of choroidal neovascularization, making α5β1 an attractive target for therapeutic strategies directed at pathological angiogenesis. JSM6427 may also interfere with other key processes in the pathogenesis of AMD, namely inflammation and fibrosis. Further, non-clinical data show that JSM6427 inhibits scarring and inflammation. Thus, JSM6427 may target multiple important pathways in the pathogenesis of neovascular AMD.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Retina Vitreous Associates Medical Group | |
| Beverly Hills, California, United States, 90211 | |
| United States, Massachusetts | |
| Ophthalmic Consultants of Boston | |
| Boston, Massachusetts, United States, 02114 | |
| United States, Michigan | |
| William Beaumont Research Institute | |
| Royal Oak, Michigan, United States, 40873 | |
| United States, Oklahoma | |
| Dean McGee Eye Institute | |
| Oklahoma City, Oklahoma, United States, 73120 | |
| United States, South Carolina | |
| Palmetto Retina Center | |
| West Columbia, South Carolina, United States, 29169 | |
| United States, South Dakota | |
| Black Hills Regional Eye Institute | |
| Rapid City, South Dakota, United States, 57701 | |
| United States, Texas | |
| Retina Research Institute of Texas | |
| Abilene, Texas, United States, 79606 | |
| Vitreoretinal Consultants | |
| Houston, Texas, United States, 77030 | |
| Valley Retina Institute | |
| McAllen, Texas, United States, 78503 | |
| Study Chair: | Anthony Adamis, MD | Jerini Ophthalmic |
More Information
| Responsible Party: | Jerini Ophthalmic |
| ClinicalTrials.gov Identifier: | NCT00536016 History of Changes |
| Other Study ID Numbers: | JO642701 |
| Study First Received: | September 25, 2007 |
| Last Updated: | September 20, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
AMD Neovascular Age-Related Macular Degeneration |
|
Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases |