NCT00006188

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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2000

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 19, 2000

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 26, 2000

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2000

Completed
7.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2008

Completed
Last Updated

July 2, 2017

Status Verified

July 25, 2008

First QC Date

August 26, 2000

Last Update Submit

June 30, 2017

Conditions

Keywords

Behcet's DiseaseSarcoidosisIritisChoroiditisIridocyclitisRetinal DiseaseCystoid Macular EdemaUveitisIntraocular InflammationInflammatory Eye DIsease

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

ChoroiditisIridocyclitisIritisRetinal DiseasesBehcet SyndromeSarcoidosisMacular EdemaUveitis

Condition Hierarchy (Ancestors)

Choroid DiseasesUveal DiseasesEye DiseasesUveitis, PosteriorPanuveitisIris DiseasesUveitis, AnteriorMouth DiseasesStomatognathic DiseasesVasculitisVascular DiseasesCardiovascular DiseasesHereditary Autoinflammatory DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, VascularLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System DiseasesMacular DegenerationRetinal Degeneration

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

August 26, 2000

First Posted

August 28, 2000

Study Start

August 19, 2000

Study Completion

July 25, 2008

Last Updated

July 2, 2017

Record last verified: 2008-07-25

Locations