NCT06753916 ExCrossV Multi Site Trial for Vascularized High Risk Keratoplasty
| NCT ID | NCT06753916 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Massachusetts Eye and Ear Infirmary |
| Condition | Corneal Transplant Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 96 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2028-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 96 participants in total. It began in 2025-04-01 with a primary completion date of 2028-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Joseph Ciolino, MD
PRINCIPAL INVESTIGATOR
Massachusetts Eye and Ear
Frequently Asked Questions
Who can join the NCT06753916 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Corneal Transplant Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06753916 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06753916 currently recruiting?
Yes, NCT06753916 is actively recruiting participants. Contact the research team at mcheung0@meei.harvard.edu for enrollment information.
Where is the NCT06753916 trial being conducted?
This trial is being conducted at Irvine, United States, Los Angeles, United States, San Francisco, United States, Miami, United States and 8 additional locations.
Who is sponsoring the NCT06753916 clinical trial?
NCT06753916 is sponsored by Massachusetts Eye and Ear Infirmary. The principal investigator is Joseph Ciolino, MD at Massachusetts Eye and Ear. The trial plans to enroll 96 participants.