Retinal Disease Clinical Trial
Official title:
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.
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."
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