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

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
United States
California
University of California Irvine - Gavin Herbert Eye Institute
NOT_YET_RECRUITING
Irvine
The University of California Los Angeles - Doris Stein Eye Research Center
NOT_YET_RECRUITING
Los Angeles
University of California San Francisco - Wayne and Gladys Valley Center for Vision
NOT_YET_RECRUITING
San Francisco
Florida
University of Miami - Bascom Palmer Eye Institute
RECRUITING
Miami
Indiana
Price Vision Group
RECRUITING
Indianapolis
Massachusetts
Massachusetts Eye and Ear
RECRUITING
Boston
Michigan
University of Michigan - Kellogg Eye Center
NOT_YET_RECRUITING
Ann Arbor
North Carolina
Wake Forest Baptist Eye Center
NOT_YET_RECRUITING
Bermuda Run
Duke University - Duke Eye Center
NOT_YET_RECRUITING
Durham
Ohio
Cincinnati Eye Institute
RECRUITING
Cincinnati
Contact Information
Primary
Michael Cheung, MSc, CCRP
mcheung0@meei.harvard.edu
6175736060
Backup
Nikolay Boychev, OD, PhD
Time Frame
Start Date: 2025-04-01
Estimated Completion Date: 2031-01-01
Participants
Target number of participants: 96
Treatments
Experimental: 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.
Placebo_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Massachusetts Eye and Ear Infirmary

This content was sourced from clinicaltrials.gov