ExCrossV Multi Site Trial for Vascularized High Risk Keratoplasty
NCT ID: NCT06753916
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
96 participants
INTERVENTIONAL
2025-04-01
2031-01-01
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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Participants Receiving Treated Cross Linked Corneal Tissue
Participants in this group will receive tissue that has been treated with 0.1% riboflavin (Vitamin B2) and 20% dextran (Photrexa® viscous and Photrexa®) with UV light treatment. Participants will be monitored over a period of 24 months.
Corneal Donor Tissue with Cross Linking
Participants are transplanted with corneal donor tissue that has been treated with 0.1% riboflavin (Vitamin B2) and 20% dextran (Photrexa® Viscous \& Photrexa®) with UV light treatment.
Participants Receiving Untreated Cross Linked Corneal Tissue
Participants in this group will receive tissue that has has not been treated with 0.1% riboflavin (Vitamin B2) and 20% dextran (Photrexa® viscous and Photrexa®) without UV light treatment. Participants will be monitored over a period of 24 months.
Corneal Donor Tissue without Cross Linking
Participants are transplanted with corneal donor tissue that has not been treated with the UV light and the 0.1% riboflavin (Vitamin B2) and 20% dextran (Photrexa® Viscous \& Photrexa®) without UV light treatment, this is the control group.
Interventions
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Corneal Donor Tissue with Cross Linking
Participants are transplanted with corneal donor tissue that has been treated with 0.1% riboflavin (Vitamin B2) and 20% dextran (Photrexa® Viscous \& Photrexa®) with UV light treatment.
Corneal Donor Tissue without Cross Linking
Participants are transplanted with corneal donor tissue that has not been treated with the UV light and the 0.1% riboflavin (Vitamin B2) and 20% dextran (Photrexa® Viscous \& Photrexa®) without UV light treatment, this is the control group.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Massachusetts Eye and Ear Infirmary
OTHER
Responsible Party
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Joseph B. Ciolino, MD
Associate Professor of Ophthalmology
Principal Investigators
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Joseph Ciolino, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts Eye and Ear
Locations
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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
Duke University - Duke Eye Center
Durham, North Carolina, United States
Cincinnati Eye Institute
Cincinnati, Ohio, United States
Countries
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Central Contacts
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Nikolay Boychev, OD, PhD
Role: CONTACT
Facility Contacts
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Beth Cutrer
Role: primary
Jeremy Sandoval
Role: primary
Javier Parades, MBA, CCRP
Role: backup
Marianne Price, PhD
Role: primary
Michael Cheung, MSc, CCRP
Role: primary
Nikolay Boychev, OD, PhD
Role: backup
Lianne Shami, BS
Role: primary
Christina Robbins
Role: primary
Nathan Hamilton
Role: primary
Kyle Munar
Role: backup
Other Identifiers
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2023P002687
Identifier Type: -
Identifier Source: org_study_id