Clinical trial NCT06753916: ExCrossV Multi Site Trial for Vascularized High Risk Keratoplasty
Official title: Multicenter Clinical Trial to Evaluate the Safety and Efficacy of Ex Vivo Corneal Cross-linking of Donor Corneal Tissue Used for Vascularized High-risk Keratoplasty
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Corneal Transplant Failure
Keywords: Keratoplasty
Cross Linking
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
First posted: 2024-12-31
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to determine the safety of Ex Vivo Cross Linking (CXL) of donor corneal tissue in participants who have undergone high-risk penetrating keratoplasty.

Detailed description: This is a randomized, double-masked, multi site clinical trial to determine the safety of Ex Vivo CXL of donor corneal tissue in 96 participants who have undergone high-risk penetrating keratoplasty.

Participants will be randomized to receive either a corneal tissue that has been untreated vs. a corneal tissue that has been treated with Photrexa® Viscous \& Photrexa® and UV light. The tissue will be prepared by a Corneal Tissue Bank under Current-Good-Tissue-Practice (CGTP) and delivered to the respective institutions for transplantation. Participants will be monitored up to 24 months post-transplantation to assess for adverse events of the randomized tissue.

Eligibility criteria: Inclusion Criteria:

* Age 18 and older
* Willing and able to provide written informed consent
* Willing and able to comply with study assessments for the full duration of the study
* Patients undergoing high-risk penetrating keratoplasty, defined as corneal neovascularization (NV) in 1 or more quadrants ≥2 mm from the limbus or extension of corneal NV to the graft-host junction in a previously failed graft
* Superficial vessels are defined as those within the anterior one-third of the cornea and deep vessels within the posterior two-thirds of the cornea (i.e., deep stroma).

Superficial CNV involving ≤2 quadrants (equivalent to ≤6 clock hours) without deep CNV are classified as mild. CNV with \>2 quadrants of superficial vessels (\>6 clock hours) or 1 quadrant of deep vessels (\>3 clock hours) as severe (36).

Exclusion Criteria:

* History of Stevens-Johnson syndrome or ocular pemphigoid
* Ocular or periocular malignancy
* Non-healing epithelial defect of at least 0.5x0.5 mm in host corneal bed lasting ≥6 weeks preoperatively
* Uncontrolled glaucoma
* Change in topical corticosteroid regimen within 14 days of transplantation
* Use of systemic immunosuppressive for indication other than corneal graft rejection
* Participation in another simultaneous medical investigation or trial
* Pregnancy (positive pregnancy test) or lactating
* Pre-menopausal women not using adequate contraception (Reliable intrauterine devices, hormonal contraception or a spermicide in combination with a barrier method)
* Ocular infection within 30 days prior to study entry.
* Presence of anterior chamber intraocular lens
* Active uveitis within 90 days prior to the study entry.
* No ocular surgery or procedure within 90 days prior to the study entry or concomitant to the study procedure.

Primary outcomes:
measure: Determining the Primary Safety of Corneal Cross Linking
timeFrame: 24 Months
Secondary outcomes:
measure: Measure of the Frequency of Graft Failures though Corneal Cross Linking
timeFrame: 24 Months
measure: Measure of Time from Surgery to Overall Graft Failure for Corneal Cross Linking over 24 Months
timeFrame: 24 Months
measure: Measure of Time from Surgery to Graft Rejection for Corneal Cross Linking over 24 Months
timeFrame: 24 Months
measure: Measure of the Efficacy of Corneal Cross Linking Through Image Review
timeFrame: 24 Months
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California Irvine - Gavin Herbert Eye Institute
state: California
city: Los Angeles
country: United States
facility: The University of California Los Angeles - Doris Stein Eye Research Center
state: California
city: Miami
country: United States
facility: University of Miami - Bascom Palmer Eye Institute
state: Florida
city: Indianapolis
country: United States
facility: Price Vision Group
state: Indiana
city: Boston
country: United States
facility: Massachusetts Eye and Ear
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan - Kellogg Eye Center
state: Michigan
city: Bermuda Run
country: United States
facility: Wake Forest Baptist Eye Center
state: North Carolina
city: Durham
country: United States
facility: Duke University - Duke Eye Center
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University - Casey Eye Institute
state: Oregon
Study officials:
affiliation: Massachusetts Eye and Ear
name: Joseph Ciolino, MD
role: PRINCIPAL_INVESTIGATOR
References: