ChoroiditisNCT00006188
Evaluation and Treatment of Patients With Inflammatory Eye Diseases
An observational study of Choroiditis and Iridocyclitis, run by National Eye Institute (NEI) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Choroiditis, Iridocyclitis, Iritis
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2000to 25 Jul 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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:
Read more
- 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.
- 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.
Read the detailed description
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."
- Conditions
- Choroiditis, Iridocyclitis, Iritis, Retinal Disease
- Keywords
- Behcet's Disease, Sarcoidosis, Iritis, Choroiditis, Iridocyclitis, Retinal Disease, Cystoid Macular Edema, Uveitis, Intraocular Inflammation, Inflammatory Eye DIsease
- Medical subject headings
- Choroiditis, Iridocyclitis, Iritis, Retinal Diseases, Behcet Syndrome, Sarcoidosis, Macular Edema, Uveitis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2000 (estimated)
- Study start19 Aug 2000
- Study completion25 Jul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChoroiditisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006188
- Sponsor's protocol ID
- 000204
- Other IDs
- 00-EI-0204
- Status last verified
- 25 Jul 2008
- First submitted
- 26 Aug 2000
- Last updated
- 2 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Treatment Protocol for Patients With Intraocular Inflammatory Disease (Uveitis)
- ClinicalTrials.gov ID
- NCT00006188
- Acronym / sponsor ID
- 000204
- Conditions
- Choroiditis, Iridocyclitis, Iritis, Retinal Disease
- Keywords
- Behcet's Disease, Sarcoidosis, Iritis, Choroiditis, Iridocyclitis, Retinal Disease, Cystoid Macular Edema, Uveitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- 19 Aug 2000
- Study completion
- 25 Jul 2008
- First posted
- 28 Aug 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Detailed description
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."
Study design
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
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Quantification & Classification of Inflammatory Cells in Uveitis Using OCT
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Choroiditis and Iridocyclitis, run by National Eye Institute (NEI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.