Safety and Efficacy of Oral PTK787 in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration (AMD)
NCT ID: NCT00138632
Last Updated: 2008-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
50 participants
INTERVENTIONAL
2005-09-30
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
PTK787
Visudyne® + PTK787, 500 mg/day
2
PTK787
Visudyne® + PTK787 1000 mg/day
3
Placebo
Visudyne® + Placebo
Interventions
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PTK787
Visudyne® + PTK787, 500 mg/day
PTK787
Visudyne® + PTK787 1000 mg/day
Placebo
Visudyne® + Placebo
Eligibility Criteria
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Inclusion Criteria
* Patients with subfoveal choroidal neovascularization secondary to AMD
Exclusion Criteria
* 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.
65 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Novartis Pharmaceuticals
Principal Investigators
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Novartis Customer Information
Role: STUDY_CHAIR
Novartis
Locations
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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
Parramatta, New South Wales, Australia
Novartis Investigational Site
Sydney, New South Wales, Australia
Novartis Investigative Site
Westmead, New South Wales, Australia
Novartis Investigative Site
East Melbourne, Victoria, Australia
Countries
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Other Identifiers
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CPTK787E2201
Identifier Type: -
Identifier Source: org_study_id