Not currently recruiting at University of California Health

ExCrossV Multi Site Trial for Vascularized High Risk Keratoplasty

a study on Corneal Transplantation

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine UCLA UCSF
Dates
study started
study ends around
Principal Investigator
by Marjan Farid, MD (uci)Anthony Aldave, MD (ucla)Julie Schallhorn, MD (ucsf)
Headshot of Julie Schallhorn
Julie Schallhorn

Description

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.

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

Details

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.

Keywords

Corneal Transplant Failure, Keratoplasty, Cross Linking, Therapeutics, Corneal Donor Tissue with Cross Linking, Corneal Donor Tissue without Cross Linking

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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.

Locations

  • University of California Irvine - Gavin Herbert Eye Institute not yet accepting patients
    Irvine 5359777 California 5332921 92617 United States
  • The University of California Los Angeles - Doris Stein Eye Research Center not yet accepting patients
    Los Angeles 5368361 California 5332921 90095 United States
  • University of California San Francisco - Wayne and Gladys Valley Center for Vision not yet accepting patients
    San Francisco 5391959 California 5332921 94158 United States
  • Price Vision Group accepting new patients
    Indianapolis 4259418 Indiana 4921868 46260 United States
  • Cincinnati Eye Institute accepting new patients
    Cincinnati 4508722 Ohio 5165418 45242 United States

Lead Scientists at University of California Health

  • Marjan Farid, MD (uci)
    Health Sciences Professor, Ophthalmology and Visual Sciences, School of Medicine. Authored (or co-authored) 66 research publications
  • Anthony Aldave, MD (ucla)
    Dr. Anthony J. Aldave holds the Bartly J. Mondino, M.D., Endowed Chair in Ophthalmology. He previously held the Walton Li Chair in Cornea and Uveitis (4/1/2014 - 6/30/2023).
  • Julie Schallhorn, MD (ucsf)
    Julie Schallhorn, MD, MS is the Rose B Williams Endowed Chair in Corneal Research and Professor of Ophthalmology at UCSF. Dr. Schallhorn received her undergraduate degree in Chemical Engineering from UCLA, and her Master’s degree in Bioengineering from UCSD. She then completed medical training at the University of Southern California Keck School of Medicine, and her ophthalmol…

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Massachusetts Eye and Ear Infirmary
ID
NCT06753916
Phase
Phase 2 Corneal Transplantation Research Study
Study Type
Interventional
Participants
Expecting 96 study participants
Last Updated