Ensayo multisitio ExCrossV para queratoplastia vascularizada de alto riesgo (ExCrossV)
Ensayo clínico multicéntrico para evaluar la seguridad y eficacia del entrecruzamiento corneal ex vivo de tejido corneal donante utilizado para queratoplastia vascularizada de alto riesgo
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Michael Cheung, MSc, CCRP
- Número de teléfono: 6175736060
- Correo electrónico: mcheung0@meei.harvard.edu
Copia de seguridad de contactos de estudio
- Nombre: Nikolay Boychev, OD, PhD
Ubicaciones de estudio
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California
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Irvine, California, Estados Unidos, 92617
- Aún no reclutando
- University of California Irvine - Gavin Herbert Eye Institute
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Investigador principal:
- Marjan Farid, MD
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Los Angeles, California, Estados Unidos, 90095
- Aún no reclutando
- The University of California Los Angeles - Doris Stein Eye Research Center
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Investigador principal:
- Anthony Aldave, MD
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San Francisco, California, Estados Unidos, 94158
- Aún no reclutando
- University of California San Francisco - Wayne and Gladys Valley Center for Vision
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Contacto:
- Beth Cutrer
- Correo electrónico: Beth.Cutrer@ucsf.edu
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Investigador principal:
- Julie Schallhorn, MD
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Florida
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Miami, Florida, Estados Unidos, 33136
- Reclutamiento
- University of Miami - Bascom Palmer Eye Institute
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Investigador principal:
- Guillermo Amescua, MD
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Contacto:
- Jeremy Sandoval
- Correo electrónico: jxs7997@med.miami.edu
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Contacto:
- Javier Parades, MBA, CCRP
- Correo electrónico: jxp2537@med.miami.edu
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46260
- Reclutamiento
- Price Vision Group
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Investigador principal:
- David Price, MD
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Contacto:
- Marianne Price, PhD
- Número de teléfono: 317-844-5530
- Correo electrónico: mprice@cornea.org
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Contacto:
- Lauren Blisset
- Número de teléfono: (317) 814-2996
- Correo electrónico: lauren@cornea.org
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Kansas
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Overland Park, Kansas, Estados Unidos, 66204
- Reclutamiento
- Kansas City Eye Clinic
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Investigador principal:
- Christopher Ketcherside, MD
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Sub-Investigador:
- Megan Haghnegahdar, MD
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Contacto:
- Megan Hefer, CCRP
- Número de teléfono: 913-341-3100
- Correo electrónico: mhefter@kceyeclinic.com
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Maryland
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Towson, Maryland, Estados Unidos, 21204
- Reclutamiento
- Mid-Atlantic Cornea Consultant
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Investigador principal:
- Sudeep Pramanik, MD
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Investigador principal:
- Alexander Altman, MD
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Contacto:
- Lauren West
- Número de teléfono: 410-616-9952
- Correo electrónico: lwest@midatlanticcornea.com
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02114
- Reclutamiento
- Massachusetts Eye and Ear
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Contacto:
- Nikolay Boychev, OD, PhD
- Correo electrónico: nboychev@meei.harvard.edu
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Investigador principal:
- Joseph Ciolino, MD
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Contacto:
- Michael Cheung, MSc, CCRP
- Número de teléfono: 617-573-6060
- Correo electrónico: mcheung0@meei.harvard.edu
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48015
- Reclutamiento
- University of Michigan - Kellogg Eye Center
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Investigador principal:
- Shahzad Mian, MD
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Contacto:
- Lianne Shami, BS
- Número de teléfono: 734-647-8397
- Correo electrónico: liannes@med.umich.edu
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North Carolina
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Bermuda Run, North Carolina, Estados Unidos, 27006
- Aún no reclutando
- Wake Forest Baptist Eye Center
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Investigador principal:
- Matthew Giegengack, MD
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Contacto:
- Christina Robbins
- Número de teléfono: 336-716-3859
- Correo electrónico: Christina.Robbins@Advocatehealth.org
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Durham, North Carolina, Estados Unidos, 27705
- Reclutamiento
- Duke University - Duke Eye Center
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Investigador principal:
- Esen Akpek, MD
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Contacto:
- Nathan Hamilton
- Número de teléfono: 919-668-0230
- Correo electrónico: nathan.hamilton@duke.edu
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Contacto:
- Kyle Munar
- Correo electrónico: kyle.munar@duke.edu
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45242
- Reclutamiento
- Cincinnati Eye Institute
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Investigador principal:
- Kavitha Sivaraman, MD
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Contacto:
- Lee Stokes
- Número de teléfono: 513-569-3213
- Correo electrónico: lstokes@cvphealth.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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. |
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.
Otros nombres:
|
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Comparador de placebos: 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. |
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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Determining the Primary Safety of Corneal Cross Linking
Periodo de tiempo: 24 Months
|
The occurrence of adverse events throughout study including:
|
24 Months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Measure of the Frequency of Graft Failures though Corneal Cross Linking
Periodo de tiempo: 24 Months
|
To determine the efficacy of using cross linked tissue for the indicated keratoplasty for the prevention of corneal graft rejection and corneal neovascularization, by measuring the frequency of primary graft failures over 24 months. |
24 Months
|
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Measure of Time from Surgery to Overall Graft Failure for Corneal Cross Linking over 24 Months
Periodo de tiempo: 24 Months
|
The efficacy of using cross linked tissue for the indicated keratoplasty for the prevention of corneal graft rejection and corneal neovascularization, by measuring the time from surgery to overall graft failure (regardless of cause). |
24 Months
|
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Measure of Time from Surgery to Graft Rejection for Corneal Cross Linking over 24 Months
Periodo de tiempo: 24 Months
|
The efficacy of using cross linked tissue for the indicated keratoplasty for the prevention of corneal graft rejection and corneal neovascularization, by measuring the occurrence of any rejection episode. (Epithelial, Endothelia, Sub Epithelial, or Mixed) determined as either definite rejection, probably rejection, and possible rejection, from the time of surgery over 24 months. |
24 Months
|
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Measure of the Efficacy of Corneal Cross Linking Through Image Review
Periodo de tiempo: 24 Months
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The efficacy of using cross linked tissue for the indicated keratoplasty for the prevention of corneal graft rejection and corneal neovascularization. 1. Corneal Neovascularization (CNV) measured and analyzed from slit-lamp photography. |
24 Months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Joseph Ciolino, MD, Massachusetts Eye and Ear
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2023P002687
Información sobre medicamentos y dispositivos, documentos del estudio
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