Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00447954
Status:
COMPLETED
Last Update Posted:
2016-11-16
First Post:
2007-03-09
Brief Title:
A Study of an Encapsulated Cell Technology ECT Implant for Patients With Atrophic Macular Degeneration
Sponsor:
Neurotech Pharmaceuticals
Organization:
Neurotech Pharmaceuticals
Study Overview
Official Title:
A Phase II Study of Implants of Encapsulated Human NTC-201 Cells Releasing Ciliary Neurotrophic Factor CNTF in Participants With Visual Acuity Impairment Associated With Atrophic Macular Degeneration
Status:
COMPLETED
Status Verified Date:
2016-11
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:
The purpose of this study is to look at the safety and effectiveness of CNTF implants on vision in participants with atrophic macular degeneration This research is being done because there are no effective therapies for people with atrophic macular degeneration Age-related macular degeneration AMD is a condition that affects the macula the central part of the retina that we use for seeing details There are two types of AMD one is the wet type in which new blood vessels grow also known as choroidal neovascularization CNV but the other is the dry type in which the healthy cells die and that is the target of this study This is called atrophic macular degeneration The implant is a small capsule that contains human retinal pigment epithelium cells These cells have been given the ability to make CNTF and release it through the capsule membrane into the surrounding fluid In this study two different CNTF dose levels will be used a high dose and a low dose as well as a sham surgery or placebo group
Detailed Description:
The study will involve about 18 visits over 1½ years for specific tests of the participants vision and health These visits may include visual exams blood draw for laboratory testing brief medical history and exam and occasionally a questionnaire survey in addition to the visits for the surgical procedures There will be about 8 centers participating in this study and up to 48 people enrolled across the US Each participant joining the study who has completed initial screening will then be scheduled to have a brief surgical procedure performed on one eye which may or may not include a very small cell-filled implant Follow-up visits for repeat assessments will be required regularly to determine if the implant being tested is safe and effective for use to treat AMD
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