drugset / Trial / NCT00138632

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

NCT00138632

Phase 1/2 Completed 50 enrolled Novartis
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2005-09
Primary completion
2007-11
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject vatalanib Small molecule 500 mg Oral
Subject vatalanib Small molecule 1000 mg Oral
Background Verteporfin Other / unclassified