Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00211484
Status:
COMPLETED
Last Update Posted:
2007-05-07
First Post:
2005-09-13
Brief Title:
Treatment of Conditions With Open Label-Anecortave Acetate Sterile Suspension 15mg Where Lesions do Not Meet Acceptable Criteria for Standard Care
Sponsor:
Manhattan Eye Ear Throat Hospital
Organization:
Manhattan Eye Ear Throat Hospital
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2007-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A compassionate method of treatment is offered to patients where lesions do not meet acceptable criteria for standard therapy Visudyne Photodynamic Therapy and laser photocoagulation treatment a treatment using heat from a fine point laser beam have not been found to be effective in treating the lesions these patients have
Anecortave acetate is an experimental drug that is being tested to prevent the growth of blood vessels under the retina in patients with age-related macular degeneration AMD
Anecortave acetate is an experimental drug that is being tested to prevent the growth of blood vessels under the retina in patients with age-related macular degeneration AMD
Detailed Description:
Patients will receive a sub-Tenon injection of 15mg of Anecortave acetate in their study eye with the use of a counter pressure device Patients will then be followed for up to 24 months The patients will have the option of extending their participation in the study for an additional 24 months Statistical analysis will include comparison of patient follow-up visual acuity and angiographic data
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