8-week extension (NCT01090310) to the 24-week week ENDURE study for maintaining uveitis suppression when reducing systemic immunosuppression in 232 patients with quiescent, non-infectious intermediate, posterior or panuveitis. The primary endpoint is recurrence defined by either: ≥ 2 step increase in vitreous haze with or without an increase in anterior chamber cell grade or decrease in best corrected visual acuity of ≥ 10 ETDRS letters. The study will start in May 10 and is expected to complete Oct 11 [3].
19/04/2010 09:25:56
NCT01032915 (ENDURE) is a 24 week multi-center, randomized, double-masked, dose-ranging PIII study vs placebo for maintaining uveitis suppression when reducing systemic immunosuppression in patients with quiescent, non-infectious intermediate, posterior or panuveitis. It will start Feb 10 and is planned to enroll 232 patients. The primary outcome is the recurrence of active intermediate, posterior, or panuveitis defined by either: ≥2 step increase in vitreous haze with or without an increase in anterior chamber cell grade or decrease in best corrected visual acuity of ≥ 10 ETDRS letters. Expected completion Jan 11 [3].
19/04/2010 09:24:53
June 2008: Proof-of-concept phase II trial (NCT00685399) to assess the safety and efficacy of intravenously administered AIN 457 in the treatment of noninfectious uveitis. The trial will enrol 65 patients in the US, and was due to be completed in December 2009.(2)
13/04/2010 11:54:46
Evidence Based eva luations
NHSC http://www.haps.bham.ac.uk/publichealth/horizon/outputs/documents/2010/may-aug/AIN-457_chronic_non-infectious_uveitis.pdf
References
Available only to registered users
Category
BNF Category: Corticosteroids and other anti-inflammatory preparations (11.04)
Pharmacology: Targets interleukin 17-alpha
Epidemiology: non-infectious uveitis affecting the posterior segment of the eye affects 0.3 - 1 people per 10,000 in the EU [5]
Indication: Uveitis
Additional Details: non-infectious posterior segment requiring immunosuppression
Method(s) of Administration
Subcutaneous
Company Information
Name: Novartis
US Name: Novartis
Further Information
Anticipated Commissioning route (England) -
In timetable: -
PbR Awaiting Update |
