Ex vivo cross-linking of donor corneas for high-risk vascularized keratoplasty
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
This test sees if treating donor corneas with ex vivo cross-linking before transplant is safe for adults having high-risk vascularized penetrating keratoplasty.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts Eye and Ear Infirmary Academic / other |
| Locations | 12 sites (Irvine, California and 11 other locations) |
| Trial ID | NCT06753916 on ClinicalTrials.gov |
What this trial studies
This randomized, double-masked, multi-site phase 2 trial will enroll 96 adults undergoing high-risk penetrating keratoplasty and randomize them to receive either untreated donor tissue or donor tissue treated ex vivo with Photrexa Viscous, Photrexa, and UV light. Donor tissues will be prepared by a Corneal Tissue Bank under Current Good Tissue Practice and delivered to the participating surgical centers. Participants will be followed for up to 24 months to monitor adverse events and graft outcomes related to the randomized tissue. The primary objective is to determine the safety of ex vivo cross-linking of donor corneas in the high-risk transplant setting.
Who should consider this trial
Good fit: Adults (18 years and older) scheduled for high-risk penetrating keratoplasty due to corneal neovascularization affecting one or more quadrants or extending to the graft-host junction, who can provide informed consent and attend follow-up visits.
Not a fit: Patients with Stevens-Johnson syndrome, ocular pemphigoid, ocular or periocular malignancy, or a non-healing epithelial defect are excluded and are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, ex vivo cross-linking of donor tissue could reduce graft failure and postoperative complications in high-risk corneal transplants by strengthening the tissue and potentially lowering rejection risk.
How similar studies have performed: Corneal cross-linking is well established for ectatic disorders, but applying ex vivo cross-linking to donor tissue for high-risk keratoplasty is a novel approach with limited prior clinical evidence.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Irvine, California and 11 other locations
- University of California Irvine - Gavin Herbert Eye Institute — Irvine, California, United States (Not_yet_recruiting)
- The University of California Los Angeles - Doris Stein Eye Research Center — Los Angeles, California, United States (Not_yet_recruiting)
- University of California San Francisco - Wayne and Gladys Valley Center for Vision — San Francisco, California, United States (Not_yet_recruiting)
- University of Miami - Bascom Palmer Eye Institute — Miami, Florida, United States (Recruiting)
- Price Vision Group — Indianapolis, Indiana, United States (Recruiting)
- Kansas City Eye Clinic — Overland Park, Kansas, United States (Recruiting)
- Mid-Atlantic Cornea Consultant — Towson, Maryland, United States (Not_yet_recruiting)
- Massachusetts Eye and Ear — Boston, Massachusetts, United States (Recruiting)
- University of Michigan - Kellogg Eye Center — Ann Arbor, Michigan, United States (Recruiting)
- Wake Forest Baptist Eye Center — Bermuda Run, North Carolina, United States (Not_yet_recruiting)
- Duke University - Duke Eye Center — Durham, North Carolina, United States (Recruiting)
- Cincinnati Eye Institute — Cincinnati, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Joseph Ciolino, MD — Massachusetts Eye and Ear
- Study coordinator: Michael Cheung, MSc, CCRP
- Email: mcheung0@meei.harvard.edu
- Phone: 6175736060
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.