Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00211315
Status:
COMPLETED
Last Update Posted:
2012-10-24
First Post:
2005-09-13
Brief Title:
Treatment of Congenital Telangiectasia Coats Disease With Open-label Anecortave Acetate 15mg
Sponsor:
Manhattan Eye Ear Throat Hospital
Organization:
Manhattan Eye Ear Throat Hospital
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2012-10
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:
None
Brief Summary:
Congenital Telangiectasia or Coats disease is an uncommon disorder that involves the growth of blood vessels of the macula These blood vessels msy extend beneth the retina to produce an area of sub-retinal neovascularizationgrowth of abnormal blood vessels under the retina which leak fluid causing reduction in vision Limited forms of treatment are available in managing the neovascularization and its consequences Anecortave Acetate injection will be considered as an attempt to control the growth of the abnormal blood vessels
Detailed Description:
After evaluation the patient will receive an injection of anecortave acetate 15mg juxtascleral with a special cannula in the study eye the patient will be contacted via phone on the day following the injection If problem arises patient has to come back to see the study doctor if patient is stable a 3 month follow-up visit will be st-upif the patient does not show improvement the patient may be offered either thermal laser or PDT If patient is stable on the month 6 visit the patient will again receive another injection of anecortave acetate The succeding follow-up schedule will be followed for a total of 24 months
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