Ignite Creation Date:
2024-05-06 @ 3:15 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04577300
Status:
RECRUITING
Last Update Posted:
2023-11-28
First Post:
2020-09-25
Brief Title:
Dual Intravitreal Implantation of NT-501 Encapsulated Cell Therapy for Glaucoma
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
A Randomized Sham Controlled Masked Phase II Study to Evaluate the Safety and Efficacy of Dual Intravitreal Implantation of NT-501 Encapsulated Cell Therapy for the Treatment of Glaucoma
Status:
RECRUITING
Status Verified Date:
2024-08
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:
To determine the safety and efficacy over 24 months of dual NT-501 CNTF encapsulated cell therapy ECT on visual impairment related to glaucoma
Detailed Description:
A randomized sham controlled masked trial of up to 30 eyes will be recruited into the study Participants with a qualifying study eye will be randomized after screening and baseline evaluations to receive 2 NT-501 ECT implants in the study eye 20 eyes 1 NT-501 ECT implant 5 eyes or a sham surgery control arm 5 eyes No explant will be required An examination for safety will occur one day and one week following implant and periodically thereafter for 24 months post-implant Patients in the control arm may be offered 2 NT-501 ECT implants after the 12-month post-operative follow-up visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None