Essai multisite ExCrossV pour la kératoplastie vascularisée à haut risque (ExCrossV)
Essai clinique multicentrique pour évaluer l'innocuité et l'efficacité de la réticulation cornéenne ex vivo du tissu cornéen d'un donneur utilisé pour la kératoplastie vascularisée à haut risque
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- Phase 2
Contacts et emplacements
Coordonnées de l'étude
- Nom: Michael Cheung, MSc, CCRP
- Numéro de téléphone: 6175736060
- E-mail: mcheung0@meei.harvard.edu
Sauvegarde des contacts de l'étude
- Nom: Nikolay Boychev, OD, PhD
Lieux d'étude
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California
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Irvine, California, États-Unis, 92617
- Pas encore de recrutement
- University of California Irvine - Gavin Herbert Eye Institute
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Chercheur principal:
- Marjan Farid, MD
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Los Angeles, California, États-Unis, 90095
- Pas encore de recrutement
- The University of California Los Angeles - Doris Stein Eye Research Center
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Chercheur principal:
- Anthony Aldave, MD
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San Francisco, California, États-Unis, 94158
- Pas encore de recrutement
- University of California San Francisco - Wayne and Gladys Valley Center for Vision
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Contact:
- Beth Cutrer
- E-mail: Beth.Cutrer@ucsf.edu
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Chercheur principal:
- Julie Schallhorn, MD
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Florida
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Miami, Florida, États-Unis, 33136
- Recrutement
- University of Miami - Bascom Palmer Eye Institute
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Chercheur principal:
- Guillermo Amescua, MD
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Contact:
- Jeremy Sandoval
- E-mail: jxs7997@med.miami.edu
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Contact:
- Javier Parades, MBA, CCRP
- E-mail: jxp2537@med.miami.edu
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Indiana
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Indianapolis, Indiana, États-Unis, 46260
- Recrutement
- Price Vision Group
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Chercheur principal:
- David Price, MD
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Contact:
- Marianne Price, PhD
- Numéro de téléphone: 317-844-5530
- E-mail: mprice@cornea.org
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Contact:
- Lauren Blisset
- Numéro de téléphone: (317) 814-2996
- E-mail: lauren@cornea.org
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Kansas
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Overland Park, Kansas, États-Unis, 66204
- Recrutement
- Kansas City Eye Clinic
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Chercheur principal:
- Christopher Ketcherside, MD
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Sous-enquêteur:
- Megan Haghnegahdar, MD
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Contact:
- Megan Hefer, CCRP
- Numéro de téléphone: 913-341-3100
- E-mail: mhefter@kceyeclinic.com
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Maryland
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Towson, Maryland, États-Unis, 21204
- Recrutement
- Mid-Atlantic Cornea Consultant
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Chercheur principal:
- Sudeep Pramanik, MD
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Chercheur principal:
- Alexander Altman, MD
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Contact:
- Lauren West
- Numéro de téléphone: 410-616-9952
- E-mail: lwest@midatlanticcornea.com
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Massachusetts
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Boston, Massachusetts, États-Unis, 02114
- Recrutement
- Massachusetts Eye and Ear
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Contact:
- Nikolay Boychev, OD, PhD
- E-mail: nboychev@meei.harvard.edu
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Chercheur principal:
- Joseph Ciolino, MD
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Contact:
- Michael Cheung, MSc, CCRP
- Numéro de téléphone: 617-573-6060
- E-mail: mcheung0@meei.harvard.edu
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Michigan
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Ann Arbor, Michigan, États-Unis, 48015
- Recrutement
- University of Michigan - Kellogg Eye Center
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Chercheur principal:
- Shahzad Mian, MD
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Contact:
- Lianne Shami, BS
- Numéro de téléphone: 734-647-8397
- E-mail: liannes@med.umich.edu
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North Carolina
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Bermuda Run, North Carolina, États-Unis, 27006
- Pas encore de recrutement
- Wake Forest Baptist Eye Center
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Chercheur principal:
- Matthew Giegengack, MD
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Contact:
- Christina Robbins
- Numéro de téléphone: 336-716-3859
- E-mail: Christina.Robbins@Advocatehealth.org
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Durham, North Carolina, États-Unis, 27705
- Recrutement
- Duke University - Duke Eye Center
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Chercheur principal:
- Esen Akpek, MD
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Contact:
- Nathan Hamilton
- Numéro de téléphone: 919-668-0230
- E-mail: nathan.hamilton@duke.edu
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Contact:
- Kyle Munar
- E-mail: kyle.munar@duke.edu
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Ohio
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Cincinnati, Ohio, États-Unis, 45242
- Recrutement
- Cincinnati Eye Institute
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Chercheur principal:
- Kavitha Sivaraman, MD
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Contact:
- Lee Stokes
- Numéro de téléphone: 513-569-3213
- E-mail: lstokes@cvphealth.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
Autres noms:
|
|
Comparateur placebo: 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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Determining the Primary Safety of Corneal Cross Linking
Délai: 24 Months
|
The occurrence of adverse events throughout study including:
|
24 Months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Measure of the Frequency of Graft Failures though Corneal Cross Linking
Délai: 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
|
|
Measure of Time from Surgery to Overall Graft Failure for Corneal Cross Linking over 24 Months
Délai: 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
|
|
Measure of Time from Surgery to Graft Rejection for Corneal Cross Linking over 24 Months
Délai: 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
|
|
Measure of the Efficacy of Corneal Cross Linking Through Image Review
Délai: 24 Months
|
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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Joseph Ciolino, MD, Massachusetts Eye and Ear
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2023P002687
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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