Patient after penetrating keratoplasty who have experienced one or more rejection episodes MedDRA version: 9.1 Level: LLT Classification code 10011017 Term: Corneal graft rejection
Conditions
Interventions
Sponsors
Lux Biosciences, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Following penetrating keratoplasty, subject must have experienced one or more episodes of corneal allograft rejection with date of diagnosis of the proximate episode within 12 months prior to study implant placement. Subject may have had a penetrating keratoplasty subsequent to the proximate rejection episode. • Subject must have recovered from the prior rejection episode(s). • Must be on a stable medical regimen for at least 14 days at the time of randomization into the study. • Study eye must be clinically quiescent for at least 14 days prior to study implant placement. • Conjunctiva must be suitable for implantation with the study device (i.e., sufficient to cover the implant and minimize the potential for extrusion). • = 18 years of age • Physical condition suitable for undergoing study drug implantation surgery, as evidenced by medical history, physical examination, vital signs and 12-lead ECG. • Must sign written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Any condition that would greatly increase the risk of non-rejection graft failure such as Stevens-Johnson syndrome, xerophthalmia or severe exposure keratitis. • Schirmer’s test = 5 mm within 5 minutes with eyes closed, using anesthesia. • Clinical evidence of limbal stem cell deficiency. • History of or active herpes simplex virus keratitis or other acute corneal infection • Uncontrolled glaucoma as evidenced by an intraocular pressure of >21 mmHg while on maximal medical therapy. • Hypotony as evidenced by an intraocular pressure of 54% [male] or Hct > 49% [female]), neutropenia (ANC < 2500 mm3) or clinically significant coagulopathy • Current malignancy or a history of malignancy (within the previous 5 years) except non-metastatic basal or squamous cell carcinoma of the skin or carcinoma-in-situ of the cervix that has been treated successfully • Non-ocular, medically significant co-morbid conditions that impair normal activities, require immunosuppression, or any medical condition that would likely have an impact on the subject’s ability to comply with the study v
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and efficacy of LX201 implantation in the prevention of corneal allograft rejection episodes or graft failure in subjects who have experienced one or more rejection episodes following penetrating keratoplasty.;Secondary Objective: N/A;Primary end point(s): Proportion of subjects experiencing efficacy failure within 52 weeks following LX201 implantation, where efficacy failure is defined as either an episode of graft rejection or graft failure. The presence of one or more of the following will constitute evidence of rejection: • = 1 keratic precipitate on the donor endothelium • subepithelial infiltrates • increased corneal thickness without aqueous cells • increased aqueous cells above the subject’s post-operative background level without an increase in corneal thickness • increased corneal thickness and increased aqueous cells • an endothelial rejection line of any length • inflammatory cells in the corneal stroma Grafts that do not clear within 10 days of surgery will be defined as primary donor failures. Grafts that clear within 10 days after surgery and later become cloudy for a continuous period of = 3 months will be declared a failure. | — |
Countries
Germany
Outcome results
None listed