Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00447642
Status:
TERMINATED
Last Update Posted:
2012-10-11
First Post:
2007-03-13
Brief Title:
Study to Assess LX201 for Prevention of Corneal Allograft Rejection or Graft Failure in Subjects Who Have Experienced One or More Rejection Episodes Following Penetrating Keratoplasty
Sponsor:
Lux Biosciences Inc
Organization:
Lux Biosciences Inc
Study Overview
Official Title:
A Multi-center Placebo-Controlled Randomized Parallel-Group Dose-Ranging Study to Assess the Efficacy and Safety of LX201 Implantation for the Prevention of Corneal Allograft Rejection Episodes or Graft Failure in Subjects Who Have Experienced One or More Rejection Episodes Following Penetrating Keratoplasty
Status:
TERMINATED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The primary efficacy endpoint was not met
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the use of LX201 to prevent future graft rejection episodes andor graft failure in patients who have undergone corneal transplantation and who have recently experienced a rejection episode due to an immune response
Detailed Description:
LX201 was a novel sustained-release silicone implant containing 30 cyclosporine A by weight LX201 is intended for surgical episcleral placement in the eye
The study was a Phase 23 multi-center placebo-controlled randomized parallel-group dose-ranging study of LX201 for prevention of corneal allograft rejection or graft failure in subjects who have had one or more rejection episodes following penetrating keratoplasty
After Visit 12 Week 52 subjects in the USA and India with the implant in the study eye were to be followed for safety at least once per year for a 2 year period or until time of implant removal In Germany the implant was to be removed at Week 52 with a 3-month safety follow-up period after removal
The study was a Phase 23 multi-center placebo-controlled randomized parallel-group dose-ranging study of LX201 for prevention of corneal allograft rejection or graft failure in subjects who have had one or more rejection episodes following penetrating keratoplasty
After Visit 12 Week 52 subjects in the USA and India with the implant in the study eye were to be followed for safety at least once per year for a 2 year period or until time of implant removal In Germany the implant was to be removed at Week 52 with a 3-month safety follow-up period after removal
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