Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00473928
Status:
COMPLETED
Last Update Posted:
2010-03-18
First Post:
2007-05-14
Brief Title:
Safety of Intravitreal POT-4 Therapy for Patients With Neovascular Age-Related Macular Degeneration AMD
Sponsor:
Potentia Pharmaceuticals Inc
Organization:
Potentia Pharmaceuticals Inc
Study Overview
Official Title:
Assessment of Safety of Intravitreal POT-4 Therapy for Patients With Neovascular Age-Related Macular Degeneration AMD
Status:
COMPLETED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASaP
Brief Summary:
The objective of this study is to provide initial safety and tolerability information of intravitreal POT-4 for treatment of patients with AMD
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None