Ex vivo cross-linking of donor corneas for high-risk vascularized keratoplasty

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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 Recruiting
• Massachusetts Eye and Ear
  Boston, Massachusetts, United States Recruiting
• University of Michigan - Kellogg Eye Center
  Ann Arbor, Michigan, 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.