Safety and Efficacy of Oral PTK787 in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration (AMD)
NCT00138632 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2008-11-14
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
Interventions
- DRUG
-
PTK787
Visudyne® + PTK787, 500 mg/day
- DRUG
-
PTK787
Visudyne® + PTK787 1000 mg/day
- DRUG
-
Visudyne® + Placebo
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis Customer Information · Novartis
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-09-30
- Primary Completion
- 2007-11-30
Countries
- United States
- Australia
Study Locations
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