ExCrossV-Multi-Site-Studie zur vaskularisierten Hochrisiko-Keratoplastik (ExCrossV)
Multizentrische klinische Studie zur Bewertung der Sicherheit und Wirksamkeit der Ex-vivo-Hornhautvernetzung von Spender-Hornhautgewebe, das für die vaskularisierte Hochrisiko-Keratoplastik verwendet wird
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 2
Kontakte und Standorte
Studienkontakt
- Name: Michael Cheung, MSc, CCRP
- Telefonnummer: 6175736060
- E-Mail: mcheung0@meei.harvard.edu
Studieren Sie die Kontaktsicherung
- Name: Nikolay Boychev, OD, PhD
Studienorte
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California
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Irvine, California, Vereinigte Staaten, 92617
- Noch keine Rekrutierung
- University of California Irvine - Gavin Herbert Eye Institute
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Hauptermittler:
- Marjan Farid, MD
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Los Angeles, California, Vereinigte Staaten, 90095
- Noch keine Rekrutierung
- The University of California Los Angeles - Doris Stein Eye Research Center
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Hauptermittler:
- Anthony Aldave, MD
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San Francisco, California, Vereinigte Staaten, 94158
- Noch keine Rekrutierung
- University of California San Francisco - Wayne and Gladys Valley Center for Vision
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Kontakt:
- Beth Cutrer
- E-Mail: Beth.Cutrer@ucsf.edu
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Hauptermittler:
- Julie Schallhorn, MD
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Florida
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Miami, Florida, Vereinigte Staaten, 33136
- Rekrutierung
- University of Miami - Bascom Palmer Eye Institute
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Hauptermittler:
- Guillermo Amescua, MD
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Kontakt:
- Jeremy Sandoval
- E-Mail: jxs7997@med.miami.edu
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Kontakt:
- Javier Parades, MBA, CCRP
- E-Mail: jxp2537@med.miami.edu
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Indiana
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Indianapolis, Indiana, Vereinigte Staaten, 46260
- Rekrutierung
- Price Vision Group
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Hauptermittler:
- David Price, MD
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Kontakt:
- Marianne Price, PhD
- Telefonnummer: 317-844-5530
- E-Mail: mprice@cornea.org
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Kontakt:
- Lauren Blisset
- Telefonnummer: (317) 814-2996
- E-Mail: lauren@cornea.org
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Kansas
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Overland Park, Kansas, Vereinigte Staaten, 66204
- Rekrutierung
- Kansas City Eye Clinic
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Hauptermittler:
- Christopher Ketcherside, MD
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Unterermittler:
- Megan Haghnegahdar, MD
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Kontakt:
- Megan Hefer, CCRP
- Telefonnummer: 913-341-3100
- E-Mail: mhefter@kceyeclinic.com
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Maryland
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Towson, Maryland, Vereinigte Staaten, 21204
- Rekrutierung
- Mid-Atlantic Cornea Consultant
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Hauptermittler:
- Sudeep Pramanik, MD
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Hauptermittler:
- Alexander Altman, MD
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Kontakt:
- Lauren West
- Telefonnummer: 410-616-9952
- E-Mail: lwest@midatlanticcornea.com
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Massachusetts
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Boston, Massachusetts, Vereinigte Staaten, 02114
- Rekrutierung
- Massachusetts Eye and Ear
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Kontakt:
- Nikolay Boychev, OD, PhD
- E-Mail: nboychev@meei.harvard.edu
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Hauptermittler:
- Joseph Ciolino, MD
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Kontakt:
- Michael Cheung, MSc, CCRP
- Telefonnummer: 617-573-6060
- E-Mail: mcheung0@meei.harvard.edu
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Michigan
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Ann Arbor, Michigan, Vereinigte Staaten, 48015
- Rekrutierung
- University of Michigan - Kellogg Eye Center
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Hauptermittler:
- Shahzad Mian, MD
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Kontakt:
- Lianne Shami, BS
- Telefonnummer: 734-647-8397
- E-Mail: liannes@med.umich.edu
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North Carolina
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Bermuda Run, North Carolina, Vereinigte Staaten, 27006
- Noch keine Rekrutierung
- Wake Forest Baptist Eye Center
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Hauptermittler:
- Matthew Giegengack, MD
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Kontakt:
- Christina Robbins
- Telefonnummer: 336-716-3859
- E-Mail: Christina.Robbins@Advocatehealth.org
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Durham, North Carolina, Vereinigte Staaten, 27705
- Rekrutierung
- Duke University - Duke Eye Center
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Hauptermittler:
- Esen Akpek, MD
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Kontakt:
- Nathan Hamilton
- Telefonnummer: 919-668-0230
- E-Mail: nathan.hamilton@duke.edu
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Kontakt:
- Kyle Munar
- E-Mail: kyle.munar@duke.edu
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Ohio
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Cincinnati, Ohio, Vereinigte Staaten, 45242
- Rekrutierung
- Cincinnati Eye Institute
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Hauptermittler:
- Kavitha Sivaraman, MD
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Kontakt:
- Lee Stokes
- Telefonnummer: 513-569-3213
- E-Mail: lstokes@cvphealth.com
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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.
Andere Namen:
|
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Placebo-Komparator: 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.
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Determining the Primary Safety of Corneal Cross Linking
Zeitfenster: 24 Months
|
The occurrence of adverse events throughout study including:
|
24 Months
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Measure of the Frequency of Graft Failures though Corneal Cross Linking
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Joseph Ciolino, MD, Massachusetts Eye and Ear
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2023P002687
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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