Evaluation and Treatment of Patients With Inflammatory Eye Diseases
| Status: | Completed |
|---|---|
| Conditions: | Ocular, Ocular, Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 4 - Any |
| Updated: | 4/21/2016 |
| Start Date: | August 2000 |
| End Date: | July 2008 |
Evaluation and Treatment Protocol for Patients With Intraocular Inflammatory Disease (Uveitis)
This study offers evaluation and treatment for patients with inflammatory eye diseases, such
as uveitis. The protocol is not designed to test new treatments; rather, patients will
receive current standard of care treatments. The purpose of the study is twofold: 1) to
allow National Eye Institute physicians to increase their knowledge of inflammatory eye
conditions and identify new avenues of possible research in this area; and 2) to establish a
pool of patients who may be eligible for new studies as they are developed. (Participants in
this protocol will not be required to join a new study; the decision will be voluntary.)
Children and adults with uveitis and other inflammatory eye diseases may be eligible for
this study. Candidates will be screened with a medical history, brief physical examination,
thorough eye examination and blood tests. The eye examination includes measurements of
visual acuity (ability to see the vision chart), eye pressure and dilation of the pupils to
examine the lens and retina (back part of the eye). Patients may also undergo the following
procedures:
1. Fundus photography - Special photographs of the inside of the eye to help evaluate the
status of the retina and evaluate changes that may occur in the future. From 2 to 20
pictures may be taken, depending on the eye condition. The camera flashes a bright
light into the eye for each picture.
2. Fluorescein angiography - Procedure to evaluate the eye's blood vessels. A yellow dye
injected into an arm vein travels to the blood vessels in the eyes. Pictures of the
retina are taken using a camera that flashes a blue light into the eye. The pictures
show if any dye has leaked from the vessels into the retina, indicating possible blood
vessel abnormality.
Participants will be followed at least 3 years. Follow-up visits are scheduled according to
the standard of care for the individual patient's eye problem. Vision will be checked at
each visit, and some of the screening tests described above may be repeated to follow the
progress of disease and evaluate the response to treatment.
as uveitis. The protocol is not designed to test new treatments; rather, patients will
receive current standard of care treatments. The purpose of the study is twofold: 1) to
allow National Eye Institute physicians to increase their knowledge of inflammatory eye
conditions and identify new avenues of possible research in this area; and 2) to establish a
pool of patients who may be eligible for new studies as they are developed. (Participants in
this protocol will not be required to join a new study; the decision will be voluntary.)
Children and adults with uveitis and other inflammatory eye diseases may be eligible for
this study. Candidates will be screened with a medical history, brief physical examination,
thorough eye examination and blood tests. The eye examination includes measurements of
visual acuity (ability to see the vision chart), eye pressure and dilation of the pupils to
examine the lens and retina (back part of the eye). Patients may also undergo the following
procedures:
1. Fundus photography - Special photographs of the inside of the eye to help evaluate the
status of the retina and evaluate changes that may occur in the future. From 2 to 20
pictures may be taken, depending on the eye condition. The camera flashes a bright
light into the eye for each picture.
2. Fluorescein angiography - Procedure to evaluate the eye's blood vessels. A yellow dye
injected into an arm vein travels to the blood vessels in the eyes. Pictures of the
retina are taken using a camera that flashes a blue light into the eye. The pictures
show if any dye has leaked from the vessels into the retina, indicating possible blood
vessel abnormality.
Participants will be followed at least 3 years. Follow-up visits are scheduled according to
the standard of care for the individual patient's eye problem. Vision will be checked at
each visit, and some of the screening tests described above may be repeated to follow the
progress of disease and evaluate the response to treatment.
This "Evaluation and Treatment Protocol" will allow the uveitis specialists and ocular
immunologists at the NEI to identify, follow and provide "standard of care" treatment to
patients with uveitis and other intraocular inflammatory disorders. A primary purpose of the
protocol is to accumulate a cohort of patients with uveitis or other intraocular
inflammatory diseases for possible participation in new NEI clinical trials and
epidemiological protocols. Also, by providing long-term follow-up and treatment for a
variety of uveitic or other intraocular inflammatory disorders, the uveitis specialists and
ocular immunologists at NEI will be better able to identify research hypotheses about these
diseases in addition to maintaining their clinical skills. The availability of cohorts of
patients with a spectrum of uveitic disorders will be valuable for the training of fellows
in intraocular inflammatory disease, an important mission of the NEI. The ability to provide
long-term follow-up and care will also facilitate referral efforts for new NEI protocols.
The uveitis specialists at the National Eye Institute will be free to choose those ocular
inflammatory conditions that interest them. However, the total number of patients that can
be enrolled in the protocol will be restricted. This protocol is not designed to test any
new treatments. Any evaluations or treatment under this protocol will be based on the
current standard of care for each uveitic syndrome.
Participants in this patient evaluation and treatment protocol will be evaluated for
potential eligibility in any new NEI clinical trials or epidemiologic protocols as they are
developed. If eligible, patients may be asked to participate in the new protocol. However,
they will not be required to enter any protocol and their decision to participate will be
entirely voluntary. No more than 150 patients will be accepted in this "Evaluation and
Treatment Protocol."
immunologists at the NEI to identify, follow and provide "standard of care" treatment to
patients with uveitis and other intraocular inflammatory disorders. A primary purpose of the
protocol is to accumulate a cohort of patients with uveitis or other intraocular
inflammatory diseases for possible participation in new NEI clinical trials and
epidemiological protocols. Also, by providing long-term follow-up and treatment for a
variety of uveitic or other intraocular inflammatory disorders, the uveitis specialists and
ocular immunologists at NEI will be better able to identify research hypotheses about these
diseases in addition to maintaining their clinical skills. The availability of cohorts of
patients with a spectrum of uveitic disorders will be valuable for the training of fellows
in intraocular inflammatory disease, an important mission of the NEI. The ability to provide
long-term follow-up and care will also facilitate referral efforts for new NEI protocols.
The uveitis specialists at the National Eye Institute will be free to choose those ocular
inflammatory conditions that interest them. However, the total number of patients that can
be enrolled in the protocol will be restricted. This protocol is not designed to test any
new treatments. Any evaluations or treatment under this protocol will be based on the
current standard of care for each uveitic syndrome.
Participants in this patient evaluation and treatment protocol will be evaluated for
potential eligibility in any new NEI clinical trials or epidemiologic protocols as they are
developed. If eligible, patients may be asked to participate in the new protocol. However,
they will not be required to enter any protocol and their decision to participate will be
entirely voluntary. No more than 150 patients will be accepted in this "Evaluation and
Treatment Protocol."
- INCLUSION CRITERIA:
Patients are initially screened for NEI protocols under the NEI screening protocol or from
the closeout of another protocol. Some of these patients will have a uveitic or other
intraocular inflammatory condition that NEI staff wishes to follow and treat. Such
patients can the be enrolled in this evaluation and treatment protocol. Each study
participant must have the ability to understand and sign an informed consent form.
EXCLUSION CRITERIA:
Patients will be excluded from this study if they are unable or unwilling to give informed
consent or the are unwilling to be followed and treated at the NEI clinical center for at
least the next 3 years.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
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