A Pilot Study of a Sustained-Release Cyclosporine A Implant for Uveitis

Date de début de l'étude : 1 mai 1998

INCLUSION CRITERIA: Age range: 15 or older. Active non-infectious intermediate, posterior or panuveitis present for at least 6 months despite systemic immunosupressive therapy including at least 20 mg of oral prednisone or use of another immunosuppressive agent. Visual acuity worse than 20/80 (55 letters) and better than 5/200 (4 letters) in the eye to receive the CsA implant, and better than 20/80 (54 letters) in the non-study eye. Bilateral or unilateral uveitis with active inflammation in one eye only (eye to be implanted). Patients may continue systemic immunosuppressants with the exception of systemic CsA. Patients may not take greater than 1 drop of topical steroid four times a day in the eye to be implanted for maintenance of anterior segment inflammation after 1 month postoperatively. Recordable electroretinogram (ERG). Willingness and the ability, with assistance of a care giver, if necessary, to comply with treatment and follow-up procedures. The ability to understand and sign an informed consent form which must be obtained prior to treatment. Negative serum pregnancy test (females of childbearing potential only). Normal serum creatinine (males 0.9 - 1.4 mg/dL, females 0.7 - 1.3 mg/dL). No current or past history of retinal detachment. EXCLUSION CRITERIA: Current or past history of retinal detachment. Pregnant or lactating patients or patients with potential for conception unless using effective contraception. Fertile males must use effective contraception. Contraception would no longer be mandatory for participation in this study at three months postoperatively assuming (1) negligible CsA absorption, (2) patient is not taking any other medications that may affect a developing fetus or spermatogenesis. Patients who received therapy within the previous one week with any nephrotoxic drugs. Patients having a known allergy to CsA. Patients receiving current therapy with CsA. Patients need to be off of systemic CsA seven days prior to implant surgery. Patients may continue other immunosuppressive therapies if needed to control inflammation in contralateral (non-study) eye provided the inflammation is currently not active.