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ExCrossV 血管化高风险角膜移植术多部位试验 (ExCrossV)

2026年9月17日 更新者：Joseph B. Ciolino, MD、Massachusetts Eye and Ear Infirmary

评估用于血管化高风险角膜移植术的供体角膜组织离体角膜交联的安全性和有效性的多中心临床试验

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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

96

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

  • 姓名：Nikolay Boychev, OD, PhD

学习地点

  • 美国
    • California
      • Irvine、California、美国、92617
        • 尚未招聘
        • University of California Irvine - Gavin Herbert Eye Institute
        • 首席研究员：
          • Marjan Farid, MD
      • Los Angeles、California、美国、90095
        • 尚未招聘
        • The University of California Los Angeles - Doris Stein Eye Research Center
        • 首席研究员：
          • Anthony Aldave, MD
      • San Francisco、California、美国、94158
        • 尚未招聘
        • University of California San Francisco - Wayne and Gladys Valley Center for Vision
        • 接触：
        • 首席研究员：
          • Julie Schallhorn, MD
    • Florida
      • Miami、Florida、美国、33136
        • 招聘中
        • University of Miami - Bascom Palmer Eye Institute
        • 首席研究员：
          • Guillermo Amescua, MD
        • 接触：
        • 接触：
    • Indiana
      • Indianapolis、Indiana、美国、46260
        • 招聘中
        • Price Vision Group
        • 首席研究员：
          • David Price, MD
        • 接触：
        • 接触：
    • Kansas
      • Overland Park、Kansas、美国、66204
        • 招聘中
        • Kansas City Eye Clinic
        • 首席研究员：
          • Christopher Ketcherside, MD
        • 副研究员：
          • Megan Haghnegahdar, MD
        • 接触：
    • Maryland
      • Towson、Maryland、美国、21204
        • 招聘中
        • Mid-Atlantic Cornea Consultant
        • 首席研究员：
          • Sudeep Pramanik, MD
        • 首席研究员：
          • Alexander Altman, MD
        • 接触：
    • Massachusetts
      • Boston、Massachusetts、美国、02114
    • Michigan
      • Ann Arbor、Michigan、美国、48015
        • 招聘中
        • University of Michigan - Kellogg Eye Center
        • 首席研究员：
          • Shahzad Mian, MD
        • 接触：
    • North Carolina
      • Bermuda Run、North Carolina、美国、27006
        • 尚未招聘
        • Wake Forest Baptist Eye Center
        • 首席研究员：
          • Matthew Giegengack, MD
        • 接触：
      • Durham、North Carolina、美国、27705
        • 招聘中
        • Duke University - Duke Eye Center
        • 首席研究员：
          • Esen Akpek, MD
        • 接触：
        • 接触：
    • Ohio
      • Cincinnati、Ohio、美国、45242
        • 招聘中
        • Cincinnati Eye Institute
        • 首席研究员：
          • Kavitha Sivaraman, MD
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：单组作业
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
程序：Corneal Donor Tissue with Cross Linking

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.

其他名称：
  • 治疗
安慰剂比较：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.
程序：Corneal Donor Tissue without Cross Linking

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.

其他名称：
  • 控制

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Determining the Primary Safety of Corneal Cross Linking
大体时间：24 Months

The occurrence of adverse events throughout study including:

  1. Ocular Safety per the incidences and severity of ocular adverse events during the study based on ophthalmic examination and participants' self-report.

  2. Short Term Safety Events (Post Surgery < 1 Month)

    • Post-Op Microbial Keratitis
    • Acute Rejection (Epithelial, Endothelial, Sub epithelial, or Mixed)

  3. Long Term Safety Events (Post Surgery > 1 Month)

    • Rejection (Epithelial, Endothelial, or Mixed)
    • Graft Failure
    • Ulcerative Keratitis
    • Persistent Epithelial Defect lasting more than 6 Weeks
24 Months

次要结果测量

结果测量
措施说明
大体时间
Measure of the Frequency of Graft Failures though Corneal Cross Linking
大体时间：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
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Massachusetts Eye and Ear Infirmary

调查人员

  • 首席研究员：Joseph Ciolino, MD、Massachusetts Eye and Ear

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年4月1日

初级完成 (估计的)

2028年1月1日

研究完成 (估计的)

2031年1月1日

研究注册日期

首次提交

2024年9月19日

首先提交符合 QC 标准的

2024年12月20日

首次发布 (实际的)

2024年12月31日

研究记录更新

最后更新发布 (实际的)

2026年9月21日

上次提交的符合 QC 标准的更新

2026年9月17日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2023P002687

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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