This study evaluates the tolerability and safety of 3 months treatment with PTK787 tablets given daily. It also explores the efficacy of the compound in patients with wet age-related macular edema. In Cohort 1 verteporfin/PDT is the active control. The protocol was amended to reflect the current standard of care for AMD. As a result, ranibizumab is the active control for Cohort 2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
Porter Adventist Hospital, Eye Lab
Denver, Colorado, United States
USF Eye Institute
Tampa, Florida, United States
Safety as assessed by visual acuity measurements, ophthalmic examinations, vital signs, laboratory assessments, and adverse events up to 12 months
Time frame: up to 12 months
Change in macular edema from Baseline up to Month 3 Change in best-corrected visual acuity (BCVA) from Baseline up to Month 3 Change in size of fluorescein leakage Baseline up to Month 3
Time frame: from baseline up to 3 months
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Springfield Clinic, LLP
Springfield, Illinois, United States
Wilmer Eye Institute
Baltimore, Maryland, United States
Lahey Clinic Medical Center, Eye institute
Peabody, Massachusetts, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States
Novartis Investigative Site
Parramatta, New South Wales, Australia
Novartis Investigational Site
Sydney, New South Wales, Australia
Novartis Investigative Site
Westmead, New South Wales, Australia
...and 1 more locations