The purpose of the extension study was to provide patients completing the 28-week core study (NCT01095250) with an opportunity to receive an additional 22 weeks of continuous treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Texas Retina Associates
Arlington, Texas, United States
Novartis Investigative Site
London, Ontario, Canada
Novartis Investigative Site
North York, Ontario, Canada
Novartis Investigative Site
Rate of recurrence
Time frame: baseline to 52 weeks
Change in immunosuppressive medication score from core study baseline
Time frame: baseline to 52 weeks
Time to recurrence after the initial induction of quiescence (≤ 0.5+ anterior chamber cell grade and ≤ 0.5+ vitreous haze grade) by study treatment or rescue medication
Time frame: baseline to 52 weeks
Mean change in best corrected visual acuity from baseline
Time frame: baseline to 52 weeks
Change from baseline in Quality of Life/Patient reported outcome assessments
Time frame: baseline to 52 weeks
Mean change in vitreous haze grade and anterior chamber cell grade from baseline to 52 weeks
Time frame: baseline to 52 weeks
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Ramat Gan, Israel
Novartis Investigative Site
Bunkyō City, Japan
Novartis Investigative Site
Fukuoka, Japan
Novartis Investigative Site
Fukushima, Japan
Novartis Investigational Site
Kyoto, Japan
Novartis Investigative Site
Sapporo, Japan
Novartis Investigative Site
Tochigi, Japan
...and 1 more locations