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Recruiting NCT06753916

ExCrossV Multi Site Trial for Vascularized High Risk Keratoplasty

Phase II Interventional Corneal Transplant Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Corneal Donor Tissue with Cross Linking, Corneal Donor Tissue without Cross Linking.
Who it may be relevant to
Registry conditions: Corneal Transplant Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Procedure 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.
  • Procedure 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.

Primary outcome measures

  • Determining the Primary Safety of Corneal Cross Linking [Time frame: 24 Months]
Secondary outcome measures (4)
  • Measure of the Frequency of Graft Failures though Corneal Cross Linking [Time frame: 24 Months]
  • Measure of Time from Surgery to Overall Graft Failure for Corneal Cross Linking over 24 Months [Time frame: 24 Months]
  • Measure of Time from Surgery to Graft Rejection for Corneal Cross Linking over 24 Months [Time frame: 24 Months]
  • Measure of the Efficacy of Corneal Cross Linking Through Image Review [Time frame: 24 Months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 12 centers
  • University of California Irvine - Gavin Herbert Eye Institute — Irvine
  • The University of California Los Angeles - Doris Stein Eye Research Center — Los Angeles
  • University of California San Francisco - Wayne and Gladys Valley Center for Vision — San Francisco
  • University of Miami - Bascom Palmer Eye Institute — Miami
  • Price Vision Group — Indianapolis
  • Kansas City Eye Clinic — Overland Park
  • Mid-Atlantic Cornea Consultant — Towson
  • Massachusetts Eye and Ear — Boston
  • … and 4 more centers

Identifiers

NCT: NCT06753916 · 2023P002687

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗