Safety and Efficacy of Oral PTK787 in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration (AMD)
- Conditions
- Wet Age-Related Macular Degeneration
- Interventions
- Drug: Placebo
- Registration Number
- NCT00138632
- Lead Sponsor
- Novartis
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 PTK787 - 2 PTK787 - 3 Placebo -
- Primary Outcome Measures
Name Time Method Safety as assessed by visual acuity measurements, ophthalmic examinations, vital signs, laboratory assessments, and adverse events up to 12 months up to 12 months
- Secondary Outcome Measures
Name Time Method Change in macular edema from Baseline up to Month 3 Change in best-corrected visual acuity (BCVA) from Baseline up to Month 3 Change in size of fluorescein leakage Baseline up to Month 3 from baseline up to 3 months
Trial Locations
- Locations (9)
Retina-Vitreous Associates Medical Group
🇺🇸Beverly Hills, California, United States
Porter Adventist Hospital, Eye Lab
🇺🇸Denver, Colorado, United States
USF Eye Institute
🇺🇸Tampa, Florida, United States
Springfield Clinic, LLP
🇺🇸Springfield, Illinois, United States
Wilmer Eye Institute
🇺🇸Baltimore, Maryland, United States
Lahey Clinic Medical Center, Eye institute
🇺🇸Peabody, Massachusetts, United States
Black Hills Regional Eye Institute
🇺🇸Rapid City, South Dakota, United States
Novartis Investigative Site
🇦🇺East Melbourne, Victoria, Australia
Novartis Investigational Site
🇦🇺Sydney, New South Wales, Australia
Retina-Vitreous Associates Medical Group🇺🇸Beverly Hills, California, United States