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NCT01369914

The Natural History of Graft-Versus-Host Disease in the Eyes

Completed Last updated 3 December 2019
What this trial tests

trial in Graft-Versus-Host Disease in 61 participants. Completed in 5 February 2016.

Timeline
20 May 2011
5 February 2016

Quick facts

Lead sponsorNational Eye Institute (NEI)
StatusCompleted
Study typeOBSERVATIONAL
Enrollment61
Start date20 May 2011
Estimated completion5 February 2016
Sites1 location across United States

Conditions studied

Sponsor

National Eye Institute (NEI)

Who can join

18 and older, any sex, with Graft-Versus-Host Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: * Stem cell transplantation (SCT) is used to treat some kinds of cancer, blood cell disorders, and immune disorders. Stem cells from a donor s blood are used to replace the recipient s stem cells in the bone marrow. The recipient s bone marrow can then produce new blood cells. Some of these new cells involved in the immune system are like the donor s cells. Sometimes immune cells from the SCT attack the recipient s normal tissues, including the eyes. This type of immune attack is called graft-versus-host disease, or GVHD. * The symptoms of ocular GVHD include eye pain, irritation, dryness, and inflammation. When it is severe and if it does not respond well to treatment, ocular GVHD may also cause vision loss. Objective: \- To learn more about graft-versus-host disease (GVHD) of the eyes in people who have had stem cell transplantation. Eligibility: * Participants must be at least 18 years of age. * They must be taking part in a study at the National Cancer Institute (NCI) or the National Heart, Lung and Blood Institute (NHLBI). * They must have a SCT scheduled within the next 30 days. Design: * The study lasts for 1 year and includes six visits to the National Eye Institute. (There is an optional visit about 1 month before your SCT.) When possible, visits for this study will be scheduled so that they can be done on the same day as your visits for the NCI or NHLBI protocol that you are taking part in. * At each visit, participants will have a medical exam and an eye history will be taken. They will have an eye exam and a test to measure the ability to make tears. Those in the study will also have tear fluid collected for analysis in a lab. Tear fluid collection is a painless process. Blood will be drawn during certain visits if it has not already been collected by the transplant team.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Ocular surface indicators and biomarkers in chronic ocular graft-versus-host disease: a prospective cohort study.
    Pietraszkiewicz AA, Payne D, Abraham M, Garced A, et al · · 2021 · cited 10× · PMID 33686249 · DOI 10.1038/s41409-021-01254-5

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Other recruiting trials for Graft-Versus-Host Disease

Currently open trials in the same condition.

Other National Eye Institute (NEI) trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01369914.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing