TerminatedPhase 1/2

Apremilast in the Treatment of Uveitis

Stopped: Investigator discretion due to lack of efficacy in three subjects enrolled

United States3 participantsStarted 2009-11

Plain-language summary

The purpose of this study is to assess the safety and efficacy of Apremilast in the treatment of uveitis.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * patients with vision-threatening autoimmune uveitis * failure to respond to prednisone and at least one other systemic immunosuppressive, or intolerance to such medications due to side effects Exclusion Criteria: * serious concomitant illness that could interfere with the subject's participation * previous or current use of an alkylating agent * use of CYP3A4 inhibitors during the trial * TNF blocker use within the 8 weeks prior to enrollment

What they're measuring

Improvement by 2 or More Lines of Best-corrected Snellen Visual Acuity in at Least One Eye

Timeframe: 6 months

Reduction in Dose of Systemic Corticosteroid or Other Immunosuppressive Therapy by at Least 50%

Timeframe: 6 months

Control of Ocular Inflammation, as Judged on Clinical Criteria, According to Standard Methods (Reduction of Anterior Chamber Cellular Activity and/or Chorioretinal Infiltrates and/or Retinal Vasculitis)

Timeframe: 6 months

Reduction in Cystoid Macular Edema

Timeframe: 6 months

Trial details

NCT IDNCT00889421

SponsorOregon Health and Science University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-06

Results submitted2014-06-06

View on ClinicalTrials.gov More Uveitis trials