NCT00116090

Systemic Immunosuppressive Therapy for Eye Diseases (SITE) Cohort Study

Completed Last updated 2 July 2017

What this trial tests

trial in Uveitis in 6,300 participants. Completed in 21 April 2008.

Timeline

16 June 2005

21 April 2008

Quick facts

Lead sponsor	National Eye Institute (NEI)
Status	Completed
Study type	OBSERVATIONAL
Enrollment	6,300
Start date	16 June 2005
Estimated completion	21 April 2008
Sites	4 locations across United States

Conditions studied

• Uveitis — all drugs for Uveitis →
• Cancer — all drugs for Cancer →
• Infection — all drugs for Infection →
• Mortality — all drugs for Mortality →

Sponsor

National Eye Institute (NEI)

Who can join

Eligibility, any sex, with Uveitis or Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will evaluate whether therapy that suppresses the immune system given to treat inflammatory diseases of the eye is associated with a greater risk of death and of cancer. Inflammatory diseases of the eye, including uveitis, scleritis, and mucous membrane pemphigoid, are major blinding diseases. For some patients, treatment with corticosteroids is not enough to control the diseases. Researchers expect to gain information about whether immunosuppressive therapy is suitable for patients and which substances should be avoided. Also, the study will evaluate the frequency of short-term complications with immunosuppressive therapy as well as benefits that the therapy can bring to treatment of eye diseases.

The medical charts of patients up to age 65 (median age range of 21 to 65) who have had an inflammatory, noninfectious eye disease may be examined for this study. A database will be constructed through a chart review of patients seen in the uveitis clinic of the National Eye Institute since 1977 and three other sites. Patients who are considered exposed to immunosuppressive therapies will be compared with two groups: the general U.S. population and an internal group of patients with the same inflammatory eye diseases who did not receive immunosuppression. Data regarding about 10,000 to 15,000 patients will be collected. Patients will not be identified by the chart reviews. The incidence of cancer will be examined as well as the outcomes of immosuppressive therapy as measured by control of the eye disease, visual sharpness, changes in the use of corticosteroids, and rates of remission-when disease symptoms are lessened.

Also examined will be medical charts of a control group of patients who did not receive immunosuppressive therapy for their uveitis. Data on cancer incidence would be more difficult to obtain, requiring personal contact with patients. In such situations, patients will be contacted by phone or mail, and those providing informed consent will be asked about their medical history, including previous occurrence of cancer and other conditions. For patients who have died, the researchers will attempt to communicate with the next of kin regarding this medical information.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Risk of Ocular Hypertension in Adults with Noninfectious Uveitis.
   Daniel E, Pistilli M, Kothari S, Khachatryan N, et al · · 2017 · cited 33× · PMID 28433444 · DOI 10.1016/j.ophtha.2017.03.041
2. Use of Immunosuppression and the Risk of Subsequent Overall or Cancer Mortality.
   Kempen JH, Newcomb CW, Washington TL, Foster CS, et al · · 2023 · cited 10× · PMID 37499954 · DOI 10.1016/j.ophtha.2023.07.023
3. Use of immunosuppression and subsequent cancer incidence: cohort study.
   Buchanich JM, Newcomb CW, Washington TL, Foster CS, et al · · 2023 · cited 4× · PMID 39886503 · DOI 10.1136/bmjonc-2023-000037