ExCrossV-onderzoek op meerdere locaties voor gevasculariseerde keratoplastiek met hoog risico (ExCrossV)
Klinisch onderzoek in meerdere centra om de veiligheid en werkzaamheid te evalueren van ex vivo crosslinking van het hoornvlies van donorhoornvliesweefsel dat wordt gebruikt voor gevasculariseerde hoogrisicokeratoplastiek
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Fase 2
Contacten en locaties
Studiecontact
- Naam: Michael Cheung, MSc, CCRP
- Telefoonnummer: 6175736060
- E-mail: mcheung0@meei.harvard.edu
Studie Contact Back-up
- Naam: Nikolay Boychev, OD, PhD
Studie Locaties
-
-
California
-
Irvine, California, Verenigde Staten, 92617
- Nog niet aan het werven
- University of California Irvine - Gavin Herbert Eye Institute
-
Hoofdonderzoeker:
- Marjan Farid, MD
-
Los Angeles, California, Verenigde Staten, 90095
- Nog niet aan het werven
- The University of California Los Angeles - Doris Stein Eye Research Center
-
Hoofdonderzoeker:
- Anthony Aldave, MD
-
San Francisco, California, Verenigde Staten, 94158
- Nog niet aan het werven
- University of California San Francisco - Wayne and Gladys Valley Center for Vision
-
Contact:
- Beth Cutrer
- E-mail: Beth.Cutrer@ucsf.edu
-
Hoofdonderzoeker:
- Julie Schallhorn, MD
-
-
Florida
-
Miami, Florida, Verenigde Staten, 33136
- Werving
- University of Miami - Bascom Palmer Eye Institute
-
Hoofdonderzoeker:
- Guillermo Amescua, MD
-
Contact:
- Jeremy Sandoval
- E-mail: jxs7997@med.miami.edu
-
Contact:
- Javier Parades, MBA, CCRP
- E-mail: jxp2537@med.miami.edu
-
-
Indiana
-
Indianapolis, Indiana, Verenigde Staten, 46260
- Werving
- Price Vision Group
-
Hoofdonderzoeker:
- David Price, MD
-
Contact:
- Marianne Price, PhD
- Telefoonnummer: 317-844-5530
- E-mail: mprice@cornea.org
-
Contact:
- Lauren Blisset
- Telefoonnummer: (317) 814-2996
- E-mail: lauren@cornea.org
-
-
Kansas
-
Overland Park, Kansas, Verenigde Staten, 66204
- Werving
- Kansas City Eye Clinic
-
Hoofdonderzoeker:
- Christopher Ketcherside, MD
-
Onderonderzoeker:
- Megan Haghnegahdar, MD
-
Contact:
- Megan Hefer, CCRP
- Telefoonnummer: 913-341-3100
- E-mail: mhefter@kceyeclinic.com
-
-
Maryland
-
Towson, Maryland, Verenigde Staten, 21204
- Werving
- Mid-Atlantic Cornea Consultant
-
Hoofdonderzoeker:
- Sudeep Pramanik, MD
-
Hoofdonderzoeker:
- Alexander Altman, MD
-
Contact:
- Lauren West
- Telefoonnummer: 410-616-9952
- E-mail: lwest@midatlanticcornea.com
-
-
Massachusetts
-
Boston, Massachusetts, Verenigde Staten, 02114
- Werving
- Massachusetts Eye and Ear
-
Contact:
- Nikolay Boychev, OD, PhD
- E-mail: nboychev@meei.harvard.edu
-
Hoofdonderzoeker:
- Joseph Ciolino, MD
-
Contact:
- Michael Cheung, MSc, CCRP
- Telefoonnummer: 617-573-6060
- E-mail: mcheung0@meei.harvard.edu
-
-
Michigan
-
Ann Arbor, Michigan, Verenigde Staten, 48015
- Werving
- University of Michigan - Kellogg Eye Center
-
Hoofdonderzoeker:
- Shahzad Mian, MD
-
Contact:
- Lianne Shami, BS
- Telefoonnummer: 734-647-8397
- E-mail: liannes@med.umich.edu
-
-
North Carolina
-
Bermuda Run, North Carolina, Verenigde Staten, 27006
- Nog niet aan het werven
- Wake Forest Baptist Eye Center
-
Hoofdonderzoeker:
- Matthew Giegengack, MD
-
Contact:
- Christina Robbins
- Telefoonnummer: 336-716-3859
- E-mail: Christina.Robbins@Advocatehealth.org
-
Durham, North Carolina, Verenigde Staten, 27705
- Werving
- Duke University - Duke Eye Center
-
Hoofdonderzoeker:
- Esen Akpek, MD
-
Contact:
- Nathan Hamilton
- Telefoonnummer: 919-668-0230
- E-mail: nathan.hamilton@duke.edu
-
Contact:
- Kyle Munar
- E-mail: kyle.munar@duke.edu
-
-
Ohio
-
Cincinnati, Ohio, Verenigde Staten, 45242
- Werving
- Cincinnati Eye Institute
-
Hoofdonderzoeker:
- Kavitha Sivaraman, MD
-
Contact:
- Lee Stokes
- Telefoonnummer: 513-569-3213
- E-mail: lstokes@cvphealth.com
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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:
|
|
Placebo-vergelijker: 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:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Determining the Primary Safety of Corneal Cross Linking
Tijdsspanne: 24 Months
|
The occurrence of adverse events throughout study including:
|
24 Months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Measure of the Frequency of Graft Failures though Corneal Cross Linking
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Joseph Ciolino, MD, Massachusetts Eye and Ear
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2023P002687
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .