The Ocular Immunology and Uveitis Foundation

Novartis LFG316

Synopsis:

This is an open-label, multicenter, proof-of-concept study assessing the use of LFG316 in patients with active non-infectious intermediate-, posterior-, or panuveitis. Approximately 25 patients with active disease are sought. Learn More

This study examines the effect of intravitreal LFG316 on patients with active non-infectious uveitis. It is an open-label design; patients will know which dose they are receiving. Males and females between the ages of 18 and 65 are targeted for enrollment of this small study.

Eligible patients will have active non-infectious uveitis, will be 18 to 65 years old, and will have to meet certain inflammation criteria. Certain conditions will exclude patients from this study, such as specific medications and endophthalmitis.

The duration of this study is 85 days with the possibility of an extension for patients that respond to medication. This is comprised of a screening period, dosing period, and then a safety follow-up. Drug is in the form of intravitreal injections. Standard ophthalmic exams are part of each exam (about once a month). Additional tests are necessary at the initiation and termination of the study – blood testing, fluorescein angiography, and best corrected visual acuity. The dosing is randomly selected.

Inclusion Criteria:

  • Age 18 to 65
  • Active non-infectious uveitis
  • Consenting, competent adults, willing to comply with all study requirements

Exclusion Criteria:

  • Active, infectious uveitis
  • Uncontrolled glaucoma
  • Certain medications and drug-eluting devices

The study includes:

  • Intravitreal injections
  • Standard ophthalmic exams
  • Laboratory blood work and urinalysis
  • Various forms of Vision Assessment

More Information about the Sponsor: Novartis, http://www.novartis.com/.

Principal Investigator: C. Stephen Foster, M.D., F.A.C.S., F.A.C.R.

Research Coordinator: If you feel that you may be eligible for this study and are interested in participating, contact Halea Meese, hmeese@mersi.com (781) 647-1431 x402.

If you are a study patient currently enrolled in this study, contact the Institutional Review Board, Quorum Review, at 1-888-776-9115 (Office hours are 8:00 AM to 5:00 PM Pacific Time, Monday through Friday). They are able to provide information on patient’s rights.

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