NCT00138632

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Wet Age-Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	PTK787	Visudyne® + PTK787, 500 mg/day
DRUG	PTK787	Visudyne® + PTK787 1000 mg/day
DRUG	Placebo	Visudyne® + Placebo

Timeline

• Start date: 2005-09-01
• Primary completion: 2007-11-01
• First posted: 2005-08-30
• Last updated: 2008-11-14

Locations

11 sites across 2 countries: United States, Australia