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Evaluation and Treatment of Patients With Inflammatory Eye Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00006188
Recruitment Status : Completed
First Posted : August 28, 2000
Last Update Posted : July 2, 2017
Information provided by:
National Institutes of Health Clinical Center (CC)

Tracking Information
First Submitted Date August 26, 2000
First Posted Date August 28, 2000
Last Update Posted Date July 2, 2017
Study Start Date August 19, 2000
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Evaluation and Treatment of Patients With Inflammatory Eye Diseases
Official Title Evaluation and Treatment Protocol for Patients With Intraocular Inflammatory Disease (Uveitis)
Brief 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. 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.

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 Type Observational
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
  • Choroiditis
  • Iridocyclitis
  • Iritis
  • Retinal Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Completed
 (submitted: July 15, 2006)
Original Enrollment
 (submitted: June 23, 2005)
Study Completion Date July 25, 2008
Primary Completion Date Not Provided
Eligibility 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.


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.

Sexes Eligible for Study: All
Ages 4 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT00006188
Other Study ID Numbers 000204
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor National Eye Institute (NEI)
Collaborators Not Provided
Investigators Not Provided
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date July 25, 2008