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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Vatalanib

Criteria

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