The Vitreous Proteome and Inflammatory Mediators in Ocular Inflammatory Disease
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Cervical Cancer, Cardiology, Ocular |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Oncology, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 2/17/2019 |
| Start Date: | May 19, 2006 |
This study will examine the proteins of people with uveitis, or inflammation of the eyes.
Evaluating the vitreous, the colorless transparent substance that fills the eyeball in back
of the lens, is now possible with the use of new microtechnology. There is an opportunity to
evaluate the kinds of proteins that are present in severe, noninfectious sight-threatening
uveitis.
Patients ages 18 and older who have been enrolled in the Multicenter Uveitis Steroid
Treatment (MUST) study at NIH may be eligible for this study. Up to 200 patients eventually
may be enrolled. Researchers will study the vitreous that will be removed from patients' eyes
during an operation to insert a steroid implant. The steroid implant is used instead of
immunosuppressive therapy, a way to reduce the action of the immune system.
Patients will undergo a procedure involving a small hole made in the eye into which the
implant is placed. Normally a small amount of the vitreous comes out during that procedure,
and in this study, the vitreous specimen will be taken for testing of inflammatory products.
At the same time, a small sample of blood, about 1-1/2 tablespoons, will be collected so that
the researchers can compare inflammatory products that may be in the blood with those in the
vitreous. If a patient needs to have the implant placed again during the study, he or she
would be asked permission for collection of the vitreous and blood samples, as previously.
Samples collected will not be used to diagnose patients' conditions or to change any
treatments being done. All samples will be labeled with special code numbers so that there is
no identifying information about patients. This study will not involve examinations or
scheduled visits of patients.
Evaluating the vitreous, the colorless transparent substance that fills the eyeball in back
of the lens, is now possible with the use of new microtechnology. There is an opportunity to
evaluate the kinds of proteins that are present in severe, noninfectious sight-threatening
uveitis.
Patients ages 18 and older who have been enrolled in the Multicenter Uveitis Steroid
Treatment (MUST) study at NIH may be eligible for this study. Up to 200 patients eventually
may be enrolled. Researchers will study the vitreous that will be removed from patients' eyes
during an operation to insert a steroid implant. The steroid implant is used instead of
immunosuppressive therapy, a way to reduce the action of the immune system.
Patients will undergo a procedure involving a small hole made in the eye into which the
implant is placed. Normally a small amount of the vitreous comes out during that procedure,
and in this study, the vitreous specimen will be taken for testing of inflammatory products.
At the same time, a small sample of blood, about 1-1/2 tablespoons, will be collected so that
the researchers can compare inflammatory products that may be in the blood with those in the
vitreous. If a patient needs to have the implant placed again during the study, he or she
would be asked permission for collection of the vitreous and blood samples, as previously.
Samples collected will not be used to diagnose patients' conditions or to change any
treatments being done. All samples will be labeled with special code numbers so that there is
no identifying information about patients. This study will not involve examinations or
scheduled visits of patients.
Newer therapies to treat many ocular disorders including uveitis are being considered and
studied. We do not have a clear picture as to what lymphokines/chemokines are present in the
vitreous or anterior chamber fluid of patients with active intraocular inflammatory disease
as well as other disorders with a proposed inflammatory component such as age related macular
degeneration (AMD) and diabetes. Further, no studies have been yet performed evaluating the
proteome of the vitreous or anterior chamber fluid in the uveitic, AMD and diabetic state.
This is a natural history study with specimens taken after indicated surgery for patients
with uveitis and other studies. Specimens of anterior chamber fluid and vitreous will be
evaluated for 32 cytokines and the proteome using systems permitting the evaluation of small
amounts of material. A serum sample will be taken at the same time to compare with the
lymphokine profile found in the vitreous. Previously, patients participating in the MUST
(Multicenter Uveitis Steroid Treatment) study, a randomized study evaluating an ocular
steroid implant versus standard immunosuppressive therapy for the treatment of intermediate
and posterior uveitis, were enrolled. However, as the MUST study is complete; we are
currently only accepting participants from the NEI or other intramural NIH studies where
permission is obtained from the patient to allow such evaluations to be done.
studied. We do not have a clear picture as to what lymphokines/chemokines are present in the
vitreous or anterior chamber fluid of patients with active intraocular inflammatory disease
as well as other disorders with a proposed inflammatory component such as age related macular
degeneration (AMD) and diabetes. Further, no studies have been yet performed evaluating the
proteome of the vitreous or anterior chamber fluid in the uveitic, AMD and diabetic state.
This is a natural history study with specimens taken after indicated surgery for patients
with uveitis and other studies. Specimens of anterior chamber fluid and vitreous will be
evaluated for 32 cytokines and the proteome using systems permitting the evaluation of small
amounts of material. A serum sample will be taken at the same time to compare with the
lymphokine profile found in the vitreous. Previously, patients participating in the MUST
(Multicenter Uveitis Steroid Treatment) study, a randomized study evaluating an ocular
steroid implant versus standard immunosuppressive therapy for the treatment of intermediate
and posterior uveitis, were enrolled. However, as the MUST study is complete; we are
currently only accepting participants from the NEI or other intramural NIH studies where
permission is obtained from the patient to allow such evaluations to be done.
- INCLUSION CRITERIA:
Participants must participate in a study that permits the evaluation of specimens.
EXCLUSION CRITERIA:
Eligible participants who do not wish to donate their vitreous specimen or anterior chamber
fluid, as appropriate, or blood sample or undergo a blood draw for the purposes of this
research study.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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