Safety and Efficacy of Oral PTK787 in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration (AMD)

A Randomized, Double-Masked, Multicenter, Phase I/II Study of the Safety of PTK787 Administered to Patients With Predominantly Classic , Minimally Classic or Occult With no Classic Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration

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.

Inclusion criteria

• Male ≥ 65 years old or female ≥ 50 years old, with aged related macular degeneration
• Patients with subfoveal choroidal neovascularization secondary to AMD

Exclusion criteria

• Eye disease that may result in visual loss during the study
• Uncontrolled high blood pressure, despite chronic stable treatment: systolic ≥ 140 mmHg, Diastolic ≥ 90 mmHg
• Chronic therapy with topical, local or systemic corticosteroids.
• Use of other investigational drugs within 30 days
• Pregnant or nursing (lactating) women.

Other protocol-defined inclusion/exclusion criteria may apply