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NCT06753916PHASE2Recruiting

ExCrossV Multi Site Trial for Vascularized High Risk Keratoplasty

Massachusetts Eye and Ear Infirmary

Start Date

4/1/2025

Completion Date

1/1/2031

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

Age Range: 18 years to No maximum

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.

Interventions

PROCEDURE

Corneal Donor Tissue with Cross Linking

PROCEDURE

Corneal Donor Tissue without Cross Linking

Interested in This Trial?

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Conditions

Corneal Transplant Failure

Locations

University of California Irvine - Gavin Herbert Eye Institute

Irvine, California 92617

United States

The University of California Los Angeles - Doris Stein Eye Research Center

Los Angeles, California 90095

United States

University of California San Francisco - Wayne and Gladys Valley Center for Vision

San Francisco, California 94158

United States

University of Miami - Bascom Palmer Eye Institute

Miami, Florida 33136

United States

Price Vision Group

Indianapolis, Indiana 46260

United States

Kansas City Eye Clinic

Overland Park, Kansas 66204

United States

Mid-Atlantic Cornea Consultant

Towson, Maryland 21204

United States

Massachusetts Eye and Ear

Boston, Massachusetts 02114

United States

University of Michigan - Kellogg Eye Center

Ann Arbor, Michigan 48015

United States

Wake Forest Baptist Eye Center

Bermuda Run, North Carolina 27006

United States

Duke University - Duke Eye Center

Durham, North Carolina 27705

United States

Cincinnati Eye Institute

Cincinnati, Ohio 45242

United States