Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00139282
Status:
TERMINATED
Last Update Posted:
2007-11-28
First Post:
2005-08-29
Brief Title:
A Safety and Efficacy Study of Squalamine Lactate for Injection MSI-1256F for Wet Age-Related Macular Degeneration
Sponsor:
Genaera Corporation
Organization:
Genaera Corporation
Study Overview
Official Title:
A Phase 3 Multicenter Randomized Double-Masked Controlled Study of Squalamine Lactate MSI-1256F for Injection for the Treatment of Subfoveal Choroidal Neovascularization Associated With Age-Related Macular Degeneration
Status:
TERMINATED
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Age-Related Macular Degeneration AMD is a degenerative eye disease of the retina that causes a progressive loss of central vision AMD is the leading cause of blindness among adults age 50 or older in the Western world AMD presents in two different types dry and the more severe wet form Wet AMD is caused by the growth of abnormal blood vessels in the macula Squalamine lactate is an investigational drug that may prevent the growth of these abnormal blood vessels This study will evaluate the safety and efficacy of Squalamine lactate in the treatment of AMD in patients the exact number of which will be determined based on data from the sponsors ongoing Phase 2 trials
The trial objective is to evaluate the safety and efficacy of two doses of Squalamine lactate for Injection administered as intravenous infusions weekly for 4 weeks followed by maintenance doses every 4 weeks through week 104 compared with the safety and efficacy in the control group
The trial objective is to evaluate the safety and efficacy of two doses of Squalamine lactate for Injection administered as intravenous infusions weekly for 4 weeks followed by maintenance doses every 4 weeks through week 104 compared with the safety and efficacy in the control group
Detailed Description:
None
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