Search / Trial NCT00001737

Cyclosporin Implant to Treat Uveitis

Launched by NATIONAL EYE INSTITUTE (NEI) · Nov 3, 1999

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Trial Information

Current as of May 23, 2024

Completed

Keywords

Eye Immunosuppression Inflammation Therapy Vitreous Uveitis

Description

Sight threatening uveitis may require long term use of systemic immunosuppressants. In some patients, aggressive systemic immunosuppressive therapy fails to control inflammation and can lead to serious side effects. Oral Cyclosporin A (CsA) has been shown in several human trials to be effective in treating chronic uveitis. This pilot study will assess the safety, and to some extent efficacy, of a novel intraocular CsA release implant in patients with active inflammation and poor visual acuity in one eye despite immunosuppressant therapy. Patients will be randomly assigned to receive in one ...

Gender

All

Eligibility criteria

  • 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.

Attachments

readout_NCT00001737_2024-05-23.pdf

4.5 MB

NCT00001737_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
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Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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