The Natural History of Graft-Versus-Host Disease in the Eyes | NCT01369914

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

NCT01369914

Sponsor

National Eye Institute (NEI)

Status

Completed

Last Update Posted

Dec 3, 2019Actual

Enrollment

61Actual

Phase

Not provided

Conditions

Graft-Versus-Host Disease

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
11-EI-0173

Status Module

Record Verification Date

Feb 5, 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 20, 2011

Primary Completion Date

Not provided

Completion Date

Feb 5, 2016

First Submitted Date

Jun 8, 2011

First Submission Date that Met QC Criteria

Jun 8, 2011

First Posted Date

Jun 9, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 30, 2019

Last Update Posted Date

Dec 3, 2019Actual

Description Module

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.

Detailed Description

OBJECTIVE:

The study objectives are to study the development of ocular graft-versus-host disease (GVHD) in participants treated with stem cell transplantation (SCT) at the NIH, including exam findings prior to SCT, changes in ocular signs and symptoms following SCT and response to standard therapy in participants identified with dry eye and ocular GVHD; to develop clinical outcome measures for early onset and more advanced ocular GVHD and provide estimates of progression rates for these outcomes; to analyze tear fluid, impression cytology (IC) and serum samples from participants undergoing SCT, to identify biomarkers or other findings which may predict the onset of ocular GVHD or correlate with disease progression or response to therapy and to establish a cohort of participants with ocular GVHD in anticipation of future clinical trials.

STUDY POPULATION:

Up to 50 adult participants undergoing SCT at the NIH, and up to 50 healthy adult participants will be enrolled.

DESIGN:

This prospective, natural history study will follow participants through 12 months post-SC, with the option to extend follow-up for up to five years.

OUTCOME MEASURES:

The primary objective outcome variable is ocular surface staining using fluorescein and lissamine green dyes, as measured by the Oxford criteria, with the scale ranging from 0 to 15 in each eye. The primary subjective outcome measure is the Ocular Surface Disease Index (OSDI), ranging from 0 to 100. Secondary outcome variables include best-corrected visual acuity (BCVA), tear film osmolarity, Schirmer s tear testing with anesthesia, meibomian gland function and tear break-up time. In addition, tear fluid biomarkers and/or IC will be studied as secondary outcome variables to determine whether changes in biomarker levels (tear fluid) or cell densities and morphologies (IC) correlate with the development or progression of ocular GVHD.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

61Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rachel J Bishop, M.D.	National Eye Institute (NEI)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Institutes of Health Clinical Center, 9000 Rockville Pike		Bethesda	Maryland	20892	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16338616	Background	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.
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