Recruiting

Phase 2

Ex Vivo Cross LinkingExCrossV Multi Site Trial for Vascularized High Risk Keratoplasty

Sponsor:

Massachusetts Eye and Ear Infirmary

Code:

NCT06753916

Conditions

Corneal Transplant Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Corneal Donor Tissue with Cross Linking

Corneal Donor Tissue without Cross Linking

Study Details

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

Study ID

NCT06753916

Start date

Apr 1, 2025

Status verified date

Apr, 2026

Completion date

Jan 1, 2031

Anticipated

Primary completion date

Jan 1, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

96 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

Determining the Primary Safety of Corneal Cross Linking [ Time Frame: 24 Months ]

Central Contacts and Locations

Central contacts

Michael Cheung, MSc, CCRP

6175736060 mcheung0@meei.harvard.edu

Locations

University of Miami - Bascom Palmer Eye Institute

Recruiting

Miami, Florida, United States, 33136

Contacts

Jeremy Sandoval

jxs7997@med.miami.edu

Javier Parades, MBA, CCRP

jxp2537@med.miami.edu

Principal Investigator:

Guillermo Amescua, MD

Price Vision Group

Recruiting

Indianapolis, Indiana, United States, 46260

Contacts

Marianne Price, PhD

317-844-5530 mprice@cornea.org

Lauren Blisset

(317) 814-2996 lauren@cornea.org

Principal Investigator:

David Price, MD

Kansas City Eye Clinic

Recruiting

Overland Park, Kansas, United States, 66204

Contacts

Megan Hefer, CCRP

913-341-3100 mhefter@kceyeclinic.com

Principal Investigator:

Christopher Ketcherside, MD

Massachusetts Eye and Ear

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Michael Cheung, MSc, CCRP

617-573-6060 mcheung0@meei.harvard.edu

Nikolay Boychev, OD, PhD

nboychev@meei.harvard.edu

Principal Investigator:

Joseph Ciolino, MD

University of Michigan - Kellogg Eye Center

Recruiting

Ann Arbor, Michigan, United States, 48015

Contacts

Lianne Shami, BS

734-647-8397 liannes@med.umich.edu

Principal Investigator:

Shahzad Mian, MD

Duke University - Duke Eye Center

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Nathan Hamilton

919-668-0230 nathan.hamilton@duke.edu

Kyle Munar

kyle.munar@duke.edu

Principal Investigator:

Esen Akpek, MD

Cincinnati Eye Institute

Recruiting

Cincinnati, Ohio, United States, 45242

Contacts

Lee Stokes

513-569-3213 lstokes@cvphealth.com

Principal Investigator:

Kavitha Sivaraman, MD

More Information

Sponsor

Massachusetts Eye and Ear Infirmary

Last update posted

Apr 21, 2026

Last verified

Apr, 2026

Keywords

Keratoplasty
Cross Linking

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Massachusetts Eye and Ear Infirmary on 2026-04-21.