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| Sponsor: | Potentia Pharmaceuticals, Inc. |
|---|---|
| Information provided by: | Potentia Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00473928 |
Purpose
The objective of this study is to provide initial safety and tolerability information of intravitreal POT-4 for treatment of patients with AMD
| Condition | Intervention | Phase |
|---|---|---|
|
Age-Related Macular Degeneration |
Drug: POT-4 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Single Blind (Subject), Uncontrolled, Single Group Assignment, Safety Study |
| Official Title: | Assessment of Safety of Intravitreal POT-4 Therapy for Patients With Neovascular Age-Related Macular Degeneration (AMD) |
| Estimated Enrollment: | 15 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Age-related macular degeneration (AMD) is the leading cause of blindness for individuals over fifty-five years of age that live in the industrialized world. It affects 5-10 million people in the US and as many as 30 million worldwide. There are two forms of the disease, both of which cause a loss of central vision. Approximately eighty-five percent of patients have the less severe dry form that produces gradual but rarely complete vision loss. The remaining fifteen percent have the severe wet, or exudative, form that causes rapid, disabling blindness. Wet AMD is further characterized by choroidal neovascularization (CNV), a growth under the macula of abnormal blood vessels originating from the choroidal capillary bed. Research has linked chronic inflammation to both forms of AMD.
Only recently, unrestrained complement activation was identified in genetic studies to be one of the key mechanisms in the pathogenesis of AMD. It has also been demonstrated that complement activation plays a crucial role in the development of CNV. Therefore, the use of intravitreal complement inhibitors may be beneficial in participants subjects with neovascular AMD.
This prospective, uncontrolled, non-randomized, dose-escalating, pilot Phase I study will provide initial safety and tolerability information on intravitreal complement inhibitor (POT-4) therapy in AMD patients with subfoveal CNV.
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| Contact: Potentia Pharmaceuticals | pot4.asaptrial@potentiapharma.com |
| United States, Arizona | |
| United States, Arizona | Recruiting |
| Tucson, Arizona, United States, 85704 | |
| United States, California | |
| United States, California | Recruiting |
| Beverly Hills, California, United States, 90211 | |
| United States, Florida | |
| United States, Florida | Recruiting |
| Miami, Florida, United States, 33136 | |
| United States, Florida | Recruiting |
| Gainesville, Florida, United States, 32610 | |
| United States, Minnesota | |
| United States, Minnesota | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| United States, New Hampshire | |
| United States, New Hampshire | Recruiting |
| Portsmouth, New Hampshire, United States, 03801 | |
| Principal Investigator: | Jason Slakter, MD | Potentia Pharmaceuticals |
More Information
| Responsible Party: | Potentia Pharmaceuticals ( Clinical Research Director ) |
| Study ID Numbers: | POT-CP1006 |
| Study First Received: | May 14, 2007 |
| Last Updated: | December 9, 2008 |
| ClinicalTrials.gov Identifier: | NCT00473928 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Macular degeration Complement |
|
Eye Diseases Retinal Degeneration Macular Degeneration Retinal Diseases |