Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00447187
Status:
TERMINATED
Last Update Posted:
2012-10-11
First Post:
2007-03-12
Brief Title:
Study to Assess the Efficacy and Safety of LX201 for Prevention of Corneal Allograft Rejection Episodes and Graft Failure in Subjects at Increased Immunological Risk
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 for Prevention of Corneal Allograft Rejection Episodes and Graft Failure Following Penetrating Keratoplasty With LX201 Implantation in Subjects Who Are at Increased Immunological Risk
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 was a pivotal trial to determine whether LX201 reduces the likelihood of a graft rejection episode following corneal transplantation in patients at high immunological risk for rejection
Detailed Description:
LX201 was a novel sustained-release silicone implant containing 30 cyclosporine A by weight LX201 was 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 following penetrating keratoplasty with LX201 implantation Subjects were to be followed in an outpatient setting for safety and efficacy at 4-6 week intervals for 52 weeks following transplantation surgery
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 For subjects in the USA and India if the implant was removed at any time prior to the 3 year safety follow-up the subject was to have a final safety follow up visit at 3 months post 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 following penetrating keratoplasty with LX201 implantation Subjects were to be followed in an outpatient setting for safety and efficacy at 4-6 week intervals for 52 weeks following transplantation surgery
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 For subjects in the USA and India if the implant was removed at any time prior to the 3 year safety follow-up the subject was to have a final safety follow up visit at 3 months post 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