Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00331331
Status:
COMPLETED
Last Update Posted:
2024-06-27
First Post:
2006-05-27
Brief Title:
The Vitreous Proteome and Inflammatory Mediators in Ocular Inflammatory Disease
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Vitreous Proteome and Inflammatory Mediators in Ocular Inflammatory Disease
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 1-12 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
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 1-12 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
Detailed Description:
Newer therapies to treat many ocular disorders including uveitis are being considered and studied We do not have a clear picture as to what lymphokineschemokines 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-EI-0068 | None | None | None |