ExCrossV Multi Site Trial for Vascularized High Risk Keratoplasty

Recruiting now · Phase 2

Conditions studied: Corneal Transplant Failure

In brief

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.

Key facts

Study ID

NCT06753916

Run by

Massachusetts Eye and Ear Infirmary

People needed

96

Starts

2025-04-01

Expected to finish

2031-01-01

Last updated by the study team

2026-04-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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 is running

• Massachusetts Eye and Ear — Boston, Massachusetts, United States (enrolling)
• University of Michigan - Kellogg Eye Center — Ann Arbor, Michigan, United States (enrolling)
• Price Vision Group — Indianapolis, Indiana, United States (enrolling)
• Duke University - Duke Eye Center — Durham, North Carolina, United States (enrolling)
• Cincinnati Eye Institute — Cincinnati, Ohio, United States (enrolling)
• Kansas City Eye Clinic — Overland Park, Kansas, United States (enrolling)
• University of Miami - Bascom Palmer Eye Institute — Miami, Florida, United States (enrolling)
• Mid-Atlantic Cornea Consultant — Towson, Maryland, 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 California Irvine - Gavin Herbert Eye Institute — Irvine, California, United States
• Wake Forest Baptist Eye Center — Bermuda Run, North Carolina, United States

Full record on ClinicalTrials.gov

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