Background: Ocular inflammatory diseases, including uveitis, scleritis, and mucous membrane pemphigoid, are major blinding eye diseases. For some patients, corticosteroid therapy is insufficient to control ocular inflammatory disease, such that immunosuppressive therapy is required. Immunosuppressive therapy for eye diseases has most commonly employed antimetabolite, T-cell inhibitor, and/or alkylating agent therapies. It has been suggested, based on studies of patients with severe systemic immunologic or other systemic diseases that such treatments may result in an increased risk of cancer and other long-term morbidities. In these studies, it has been difficult to determine whether the excess risk arose from the underlying systemic diseases or the treatment.

Aims: The Systemic Immunosuppressive Therapy for Eye Diseases (SITE) Cohort Study will evaluate directly whether immunosuppressive therapy for ocular inflammatory diseases is associated with an excess risk of mortality and of cancer. The study is expected to generate critical information in deciding whether immunosuppressive therapy is warranted for such patients, and whether certain immunosuppressive agents should be avoided. In addition, the study will evaluate the frequency of short-term complications with such therapy, and the ocular benefits of therapy.

Mathods: The SITE Study will have a classic retrospective cohort design. A database will be constructed through a chart review of patients seen here in the Uveitis clinic of the NEI since 1977 and 3 other sites. Patients "exposed" to immunosuppressive therapies will be compared to two groups: 1) an external standard, the general United States population; and 2) an internal comparison group, patients with the same ocular inflammatory diseases who did not receive immunosuppression. Approximately 10000-15000 patients will be accrued from four centers which pioneered the use of immunosuppressive therapy for eye diseases, beginning 19-29 years ago. Patients who received immunosuppressive therapy for eye diseases, and patients with the same ocular inflammatory diagnoses who did not, will be identified by the chart reviews. Those who subsequently have died will be identified through a search of the National Death Index and/or the Social Security Death Index.

Condition
Uveitis Cancer Infection Mortality Immunosupression

Further Study Details: 

Expected Total Enrollment:  6300

Background: Ocular inflammatory diseases, including uveitis, scleritis, and mucous membrane pemphigoid, are major blinding eye diseases. For some patients, corticosteroid therapy is insufficient to control ocular inflammatory disease, such that immunosuppressive therapy is required. Immunosuppressive therapy for eye diseases has most commonly employed antimetabolite, T-cell inhibitor, and/or alkylating agent therapies. It has been suggested, based on studies of patients with severe systemic immunologic or other systemic diseases that such treatments may result in an increased risk of cancer and other long-term morbidities. In these studies, it has been difficult to determine whether the excess risk arose from the underlying systemic diseases or the treatment.

Aims: The Systemic Immunosuppressive Therapy for Eye Diseases (SITE) Cohort Study will evaluate directly whether immunosuppressive therapy for ocular inflammatory diseases is associated with an excess risk of mortality and of cancer. The study is expected to generate critical information in deciding whether immunosuppressive therapy is warranted for such patients, and whether certain immunosuppressive agents should be avoided. In addition, the study will evaluate the frequency of short-term complications with such therapy, and the ocular benefits of therapy.

Methods: The SITE Study will have a classic retrospective cohort design. A database will be constructed through a chart review of patients seen here in the Uveitis clinic of the NEI since 1977 and 3 other sites. Patients "exposed" to immunosuppressive therapies will be compared to two groups: 1) an external standard, the general United States population; and 2) an internal comparison group, patients with the same ocular inflammatory diseases who did not receive immunosuppression. Approximately 10000-15000 patients will be accrued from four centers which pioneered the use of immunosuppressive therapy for eye diseases, beginning 19-29 years ago. Patients who received immunosuppressive therapy for eye diseases, and patients with the same ocular inflammatory diagnoses who did not, will be identified by the chart reviews. Those who subsequently have died will be identified through a search of the National Death Index and/or the Social Security Death Index.

Genders Eligible for Study:  Both

Criteria

INCLUSION CRITERIA: Patients with the following diagnoses will be included:

Anterior uveitis;

Intermediate uveitis;

Posterior uveitis or panuveitis;

Scleritis;

Mucous membrane pemphigoid;

Other non-infectious ocular inflammatory disease.

EXCLUSION CRITERIA:

No ocular inflammatory disease;

Infectious ocular inflammatory disease (e.g. toxoplasmic retinitis, endophthalmitis, viral retinitis), unless the infectious uveitis followed treatment for a non-infectious ocular inflammatory disease.

Please refer to this study by ClinicalTrials.gov identifier  NCT00116090

Maryland
      National Eye Institute (NEI), 9000 Rockville Pike,  Bethesda,  Maryland,  20892,  United States; Recruiting

Study ID Numbers:  050178; 05-EI-0178
Record last reviewed:  May 31, 2005
Last Updated:  June 28, 2005
Record first received:  June 26, 2005
ClinicalTrials.gov Identifier:  NCT00116090
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-07-05