ExCrossV Multi Site Trial for Vascularized High Risk Keratoplasty

NCT06753916 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2023P002687
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Corneal Transplant Failure

Keywords

Keratoplasty; Cross Linking

Outcome Measures

Primary Outcomes (1)

• Determining the Primary Safety of Corneal Cross Linking

  The occurrence of adverse events throughout study including: 1. Ocular Safety per the incidences and severity of ocular adverse events during the study based on ophthalmic examination and participants' self-report. 2. Short Term Safety Events (Post Surgery \< 1 Month) * Post-Op Microbial Keratitis * Acute Rejection (Epithelial, Endothelial, Sub epithelial, or Mixed) 3. Long Term Safety Events (Post Surgery \> 1 Month) * Rejection (Epithelial, Endothelial, or Mixed) * Graft Failure * Ulcerative Keratitis * Persistent Epithelial Defect lasting more than 6 Weeks

  24 Months

Secondary Outcomes (4)

• Measure of the Frequency of Graft Failures though Corneal Cross Linking

  24 Months

• Measure of Time from Surgery to Overall Graft Failure for Corneal Cross Linking over 24 Months

  24 Months

• Measure of Time from Surgery to Graft Rejection for Corneal Cross Linking over 24 Months

  24 Months

• Measure of the Efficacy of Corneal Cross Linking Through Image Review

  24 Months

Study Arms (2)

Participants Receiving Treated Cross Linked Corneal Tissue

EXPERIMENTAL

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.

Procedure: Corneal Donor Tissue with Cross Linking

Participants Receiving Untreated Cross Linked Corneal Tissue

PLACEBO COMPARATOR

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.

Procedure: Corneal Donor Tissue without Cross Linking

Interventions

Corneal Donor Tissue with Cross Linking PROCEDURE

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.

Also known as: Treatment

Participants Receiving Treated Cross Linked Corneal Tissue

Corneal Donor Tissue without Cross Linking PROCEDURE

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.

Also known as: Control

Participants Receiving Untreated Cross Linked Corneal Tissue

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead

Study Sites (12)

University of California Irvine - Gavin Herbert Eye Institute

Irvine, California, 92617, United States

NOT YET RECRUITING

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

Los Angeles, California, 90095, United States

NOT YET RECRUITING

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

San Francisco, California, 94158, United States

NOT YET RECRUITING

University of Miami - Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

RECRUITING

Price Vision Group

Indianapolis, Indiana, 46260, United States

RECRUITING

Kansas City Eye Clinic

Overland Park, Kansas, 66204, United States

RECRUITING

Mid-Atlantic Cornea Consultant

Towson, Maryland, 21204, United States

NOT YET RECRUITING

Massachusetts Eye and Ear

Boston, Massachusetts, 02114, United States

RECRUITING

University of Michigan - Kellogg Eye Center

Ann Arbor, Michigan, 48015, United States

RECRUITING

Wake Forest Baptist Eye Center

Bermuda Run, North Carolina, 27006, United States

NOT YET RECRUITING

Duke University - Duke Eye Center

Durham, North Carolina, 27705, United States

RECRUITING

Cincinnati Eye Institute

Cincinnati, Ohio, 45242, United States

RECRUITING

MeSH Terms

Interventions

Therapeutics

Study Officials

• Joseph Ciolino, MD

  Massachusetts Eye and Ear

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Cheung, MSc, CCRP

CONTACT

6175736060; mcheung0@meei.harvard.edu

Nikolay Boychev, OD, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Ophthalmology

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: December 31, 2024
• Study Start: April 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2031
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

US (12)