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ExCrossV Multi Site Trial for Vascularized High Risk Keratoplasty | Clinical Trials | Clareo Health

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ExCrossV Multi Site Trial for Vascularized High Risk 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

NCT06753916•Massachusetts Eye and Ear Infirmary

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+3 more criteria

Locations (12)

University of California Irvine - Gavin Herbert Eye Institute

Irvine, California, United States

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

Los Angeles, California, United States

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

San Francisco, California, United States

University of Miami - Bascom Palmer Eye Institute

Miami, Florida, United States

Price Vision Group

Indianapolis, Indiana, United States

Kansas City Eye Clinic

Overland Park, Kansas, United States

Mid-Atlantic Cornea Consultant

Towson, Maryland, United States

Massachusetts Eye and Ear

Boston, Massachusetts, United States

University of Michigan - Kellogg Eye Center

Ann Arbor, Michigan, United States

Wake Forest Baptist Eye Center

Bermuda Run, North Carolina, United States

Key Dates

Start Date

April 1, 2025

Primary Completion Date

January 1, 2028

Completion Date

January 1, 2031

Last Updated

December 22, 2025

Enrollment

ESTIMATED participants

Conditions

Corneal Transplant Failure

Interventions

Corneal Donor Tissue with Cross Linking

PROCEDURE

Corneal Donor Tissue without Cross Linking

PROCEDURE

Contacts

Michael Cheung, MSc, CCRP

CONTACT

6175736060 mcheung0@meei.harvard.edu

Nikolay Boychev, OD, PhD

CONTACT

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 22, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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