The Natural History of Graft-Versus-Host Disease in the Eyes
| Status: | Completed |
|---|---|
| Conditions: | Orthopedic, Hematology |
| Therapuetic Areas: | Hematology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/6/2019 |
| Start Date: | May 20, 2011 |
| End Date: | February 5, 2016 |
The Natural History of Ocular Graft-Versus Host Disease
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.
- 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.
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.
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.
- INCLUSION CRITERIA:
SCT Participants
1. Participant must be 18 years of age or older.
2. Participant must understand and sign the protocol s informed consent document.
3. Participant is scheduled for a SCT under another NIH protocol within the next 30 days.
4. Participant is willing and able to comply with the study procedures and follow-up
visits.
Healthy Participants
1. Participant must be 18 years of age or older.
2. Participant must understand and sign the protocol s informed consent document.
3. 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
1. 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.
2. Participant has known allergies to dilating or anesthetic eye drops.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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