Corneal Transplantation Clinical Trial
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
This study will evaluate the use of LX201 to prevent future graft rejection episodes and/or graft failure in patients who have undergone corneal transplantation and who have recently experienced a rejection episode due to an immune response.
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 2/3, 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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT01206127 -
DSAEK- Postoperative Positioning and Transplant Dislocation
|
N/A | |
| Terminated |
NCT00764582 -
Ocular Penetration of 1.5% Levofloxacin and 0.5% Moxifloxacin During Corneal Transplant Surgery
|
Phase 4 | |
| Recruiting |
NCT05870566 -
Pretreatment to Promote Graft Survival After Subsequent High-risk Corneal Transplantation [CrossCornealVision]
|
N/A | |
| Recruiting |
NCT02084745 -
Timing of Glaucoma Drainage Device With Boston Keratoprosthesis
|
N/A | |
| Unknown status |
NCT00834782 -
Comparison of DCT, ORA and GAT in Eyes After Penetrating Keratoplasty
|
Phase 4 | |
| Withdrawn |
NCT00345020 -
Deep Lamellar Endothelial Keratoplasty: Small Incision Technique
|
||
| Completed |
NCT00000137 -
Collaborative Corneal Transplantation Studies (CCTS)
|
Phase 3 | |
| Recruiting |
NCT04339907 -
Inflammatory Mediators of Glaucoma After Corneal Transplantation (AH-Tears)
|
N/A | |
| Active, not recruiting |
NCT00874835 -
Corneal Endothelium Delivery Instrument
|
Phase 2 | |
| Completed |
NCT00570648 -
A Prospective Study of the Effect of Topical Sodium Hyaluronate Immediately Post-PKP on Time to Reepithelialization
|
N/A | |
| Enrolling by invitation |
NCT03461978 -
Ultrahigh-resolution Optical Coherence Tomography Imaging of the Anterior Eye Segment Structures
|
N/A | |
| Not yet recruiting |
NCT05210478 -
Intraoperative Optical Coherence Tomography for Ophthalmic Surgical Guidance - Cornea
|
||
| Completed |
NCT01694914 -
Comparative Study of Two Corneal Graft Storage Media: New Animal Compound Free Medium Versus Reference Medium
|
Phase 3 | |
| Completed |
NCT03381794 -
The German Keratoplasty Registry of the German Ophthalmological Society (DOG)
|
N/A | |
| Recruiting |
NCT03105466 -
Prospective Study of Deep Anterior Lamellar Keratoplasty Using Acellular Porcine Cornea
|
N/A | |
| Completed |
NCT00409656 -
Prospective, Randomized Trial of Basiliximab (Simulect) in the Prophylaxis of High-Risk Keratoplasty Patients
|
Phase 2 | |
| Recruiting |
NCT01018888 -
Safety and Efficacy Study of Artificial Cornea
|
Phase 4 | |
| Recruiting |
NCT04490902 -
Clinical Study on the Treatment of Mixed Component Cornea for High Risk Keratoplasty
|
N/A | |
| Recruiting |
NCT04337944 -
Endoscopic Assisted Anterior Hyaloid Peeling in Boston Type 1 Keratoprosthesis (KPro-HP-Endo)
|
N/A | |
| Completed |
NCT01547975 -
Retrospective Analysis of Surgical Outcomes After Corneal Transplantation
|
N/A |