혈관화 고위험 각막이식술을 위한 ExCrossV 다중 현장 시험 (ExCrossV)
혈관화 고위험 각막이식술에 사용되는 기증 각막 조직의 생체외 각막 가교의 안전성과 유효성을 평가하기 위한 다기관 임상시험
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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Michael Cheung, MSc, CCRP
- 전화번호: 6175736060
- 이메일: mcheung0@meei.harvard.edu
연구 연락처 백업
- 이름: Nikolay Boychev, OD, PhD
연구 장소
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California
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Irvine, California, 미국, 92617
- 아직 모집하지 않음
- University of California Irvine - Gavin Herbert Eye Institute
-
수석 연구원:
- Marjan Farid, MD
-
Los Angeles, California, 미국, 90095
- 아직 모집하지 않음
- The University of California Los Angeles - Doris Stein Eye Research Center
-
수석 연구원:
- Anthony Aldave, MD
-
San Francisco, California, 미국, 94158
- 아직 모집하지 않음
- University of California San Francisco - Wayne and Gladys Valley Center for Vision
-
연락하다:
- Beth Cutrer
- 이메일: Beth.Cutrer@ucsf.edu
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수석 연구원:
- Julie Schallhorn, MD
-
-
Florida
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Miami, Florida, 미국, 33136
- 모병
- University of Miami - Bascom Palmer Eye Institute
-
수석 연구원:
- Guillermo Amescua, MD
-
연락하다:
- Jeremy Sandoval
- 이메일: jxs7997@med.miami.edu
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연락하다:
- Javier Parades, MBA, CCRP
- 이메일: jxp2537@med.miami.edu
-
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Indiana
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Indianapolis, Indiana, 미국, 46260
- 모병
- Price Vision Group
-
수석 연구원:
- David Price, MD
-
연락하다:
- Marianne Price, PhD
- 전화번호: 317-844-5530
- 이메일: mprice@cornea.org
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연락하다:
- Lauren Blisset
- 전화번호: (317) 814-2996
- 이메일: lauren@cornea.org
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Kansas
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Overland Park, Kansas, 미국, 66204
- 모병
- Kansas City Eye Clinic
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수석 연구원:
- Christopher Ketcherside, MD
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부수사관:
- Megan Haghnegahdar, MD
-
연락하다:
- Megan Hefer, CCRP
- 전화번호: 913-341-3100
- 이메일: mhefter@kceyeclinic.com
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Maryland
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Towson, Maryland, 미국, 21204
- 모병
- Mid-Atlantic Cornea Consultant
-
수석 연구원:
- Sudeep Pramanik, MD
-
수석 연구원:
- Alexander Altman, MD
-
연락하다:
- Lauren West
- 전화번호: 410-616-9952
- 이메일: lwest@midatlanticcornea.com
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Massachusetts
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Boston, Massachusetts, 미국, 02114
- 모병
- Massachusetts Eye and Ear
-
연락하다:
- Nikolay Boychev, OD, PhD
- 이메일: nboychev@meei.harvard.edu
-
수석 연구원:
- Joseph Ciolino, MD
-
연락하다:
- Michael Cheung, MSc, CCRP
- 전화번호: 617-573-6060
- 이메일: mcheung0@meei.harvard.edu
-
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Michigan
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Ann Arbor, Michigan, 미국, 48015
- 모병
- University of Michigan - Kellogg Eye Center
-
수석 연구원:
- Shahzad Mian, MD
-
연락하다:
- Lianne Shami, BS
- 전화번호: 734-647-8397
- 이메일: liannes@med.umich.edu
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North Carolina
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Bermuda Run, North Carolina, 미국, 27006
- 아직 모집하지 않음
- Wake Forest Baptist Eye Center
-
수석 연구원:
- Matthew Giegengack, MD
-
연락하다:
- Christina Robbins
- 전화번호: 336-716-3859
- 이메일: Christina.Robbins@Advocatehealth.org
-
Durham, North Carolina, 미국, 27705
- 모병
- Duke University - Duke Eye Center
-
수석 연구원:
- Esen Akpek, MD
-
연락하다:
- Nathan Hamilton
- 전화번호: 919-668-0230
- 이메일: nathan.hamilton@duke.edu
-
연락하다:
- Kyle Munar
- 이메일: kyle.munar@duke.edu
-
-
Ohio
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Cincinnati, Ohio, 미국, 45242
- 모병
- Cincinnati Eye Institute
-
수석 연구원:
- Kavitha Sivaraman, MD
-
연락하다:
- Lee Stokes
- 전화번호: 513-569-3213
- 이메일: lstokes@cvphealth.com
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-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
다른 이름들:
|
|
위약 비교기: 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.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Determining the Primary Safety of Corneal Cross Linking
기간: 24 Months
|
The occurrence of adverse events throughout study including:
|
24 Months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Measure of the Frequency of Graft Failures though Corneal Cross Linking
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Joseph Ciolino, MD, Massachusetts Eye and Ear
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .