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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PTK787 | Drug | Visudyne® + PTK787, 500 mg/day |
| |
| PTK787 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety as assessed by visual acuity measurements, ophthalmic examinations, vital signs, laboratory assessments, and adverse events up to 12 months | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | from baseline up to 3 months |
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Inclusion criteria
Exclusion criteria
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Customer Information | Novartis | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retina-Vitreous Associates Medical Group | Beverly Hills | California | 90211 | United States | ||
| Porter Adventist Hospital, Eye Lab |
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| Drug |
Visudyne® + PTK787 1000 mg/day |
|
| Placebo | Drug | Visudyne® + Placebo |
|
| Denver |
| Colorado |
| 80210 |
| United States |
| USF Eye Institute | Tampa | Florida | 33612-4742 | United States |
| Springfield Clinic, LLP | Springfield | Illinois | 62701 | United States |
| Wilmer Eye Institute | Baltimore | Maryland | 21287 | United States |
| Lahey Clinic Medical Center, Eye institute | Peabody | Massachusetts | 01960 | United States |
| Black Hills Regional Eye Institute | Rapid City | South Dakota | 05770 | United States |
| Novartis Investigative Site | Parramatta | New South Wales | 2150 | Australia |
| Novartis Investigational Site | Sydney | New South Wales | 2000 | Australia |
| Novartis Investigative Site | Westmead | New South Wales | 2145 | Australia |
| Novartis Investigative Site | East Melbourne | Victoria | 3002 | Australia |
| ID | Term |
|---|---|
| C404768 | vatalanib |
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