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

NCT01369914 | Completed

• 2 other identifiers: 11017311-EI-0173
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Graft-Versus-Host Disease

Keywords

Graft-Versus-Host Disease; Natural History Study; Hematopoietic Stem Cell Transplant; GVHD

Outcome Measures

Primary Outcomes (1)

• The primary objective variable is ocular surface staining using fluorescein and lissamine green dyes. The primary subjective outcome measure is the OSDI

  Ongoing

Secondary Outcomes (2)

• In addition, tear fluid biomarkers and conjunctival IC will be studied as a secondary outcome variable to determine whether changes in biomarker levels or cell densities and morphologies correlate with the development or progression of ocular GV...

  Ongoing

• Secondary outcome variables include changes in BCVA (ETDRS); tear film osmolarity; Schirmer's testing with anesthesia; meibomain gland function; tear break-up time.

  Ongoing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• SCT Participants
• Participant must be 18 years of age or older.
• Participant must understand and sign the protocol s informed consent document.
• Participant is scheduled for a SCT under another NIH protocol within the next 30 days.
• Participant is willing and able to comply with the study procedures and follow-up visits.
• Healthy Participants
• Participant must be 18 years of age or older.
• Participant must understand and sign the protocol s informed consent document.
• Participant has no more than minimal current dry eye disease, defined as no more than minimal dry eye symptoms, Schirmer s with anesthesia (Bullet) 6, tear break-up time (TBUT) (Bullet) 6, and corneal staining (Oxford) \< 3 in both eyes.

You may not qualify if:

• SCT Participants
• Participant has a history of ocular problems which could interfere with the natural history of their response to treatment with SCT. Examples include significant dry eye disease, use of cyclosporine eye drops in the past 30 days and conjunctival scarring for any reason.
• Participant has known allergies to dilating or anesthetic eye drops.

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Filipovich AH, Weisdorf D, Pavletic S, Socie G, Wingard JR, Lee SJ, Martin P, Chien J, Przepiorka D, Couriel D, Cowen EW, Dinndorf P, Farrell A, Hartzman R, Henslee-Downey J, Jacobsohn D, McDonald G, Mittleman B, Rizzo JD, Robinson M, Schubert M, Schultz K, Shulman H, Turner M, Vogelsang G, Flowers ME. National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and staging working group report. Biol Blood Marrow Transplant. 2005 Dec;11(12):945-56. doi: 10.1016/j.bbmt.2005.09.004.

  PMID: 16338616 BACKGROUND

• Jabs DA, Wingard J, Green WR, Farmer ER, Vogelsang G, Saral R. The eye in bone marrow transplantation. III. Conjunctival graft-vs-host disease. Arch Ophthalmol. 1989 Sep;107(9):1343-8. doi: 10.1001/archopht.1989.01070020413046.

  PMID: 2675805 BACKGROUND

• Kim SK. Update on ocular graft versus host disease. Curr Opin Ophthalmol. 2006 Aug;17(4):344-8. doi: 10.1097/01.icu.0000233952.09595.d8.

  PMID: 16900025 BACKGROUND

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Rachel J Bishop, M.D.

  National Eye Institute (NEI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2011
• First Posted: June 9, 2011
• Study Start: May 20, 2011
• Study Completion: February 5, 2016
• Last Updated: December 3, 2019

Record last verified: 2016-02-05

Locations

US (1)