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

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ClinicalTrials.gov Identifier: NCT00138632
Recruitment Status : Completed
First Posted : August 30, 2005
Last Update Posted : November 14, 2008
Sponsor:
Information provided by:
Novartis

Study Description
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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.


Condition or disease Intervention/treatment Phase
Wet Age-Related Macular Degeneration Drug: PTK787 Drug: Placebo Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2005
Actual Primary Completion Date : November 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: PTK787
Visudyne® + PTK787, 500 mg/day
Experimental: 2 Drug: PTK787
Visudyne® + PTK787 1000 mg/day
Placebo Comparator: 3 Drug: Placebo
Visudyne® + Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Safety as assessed by visual acuity measurements, ophthalmic examinations, vital signs, laboratory assessments, and adverse events up to 12 months [ Time Frame: up to 12 months ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: from baseline up to 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Male ≥ 65 years old or female ≥ 50 years old, with aged related macular degeneration
  • Patients with subfoveal choroidal neovascularization secondary to AMD

Exclusion criteria

  • Eye disease that may result in visual loss during the study
  • 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.

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00138632


Locations
United States, California
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
United States, Colorado
Porter Adventist Hospital, Eye Lab
Denver, Colorado, United States, 80210
United States, Florida
USF Eye Institute
Tampa, Florida, United States, 33612-4742
United States, Illinois
Springfield Clinic, LLP
Springfield, Illinois, United States, 62701
United States, Maryland
Wilmer Eye Institute
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Lahey Clinic Medical Center, Eye institute
Peabody, Massachusetts, United States, 01960
United States, South Dakota
Black Hills Regional Eye Institute
Rapid City, South Dakota, United States, 05770
Australia, New South Wales
Novartis Investigative Site
Parramatta, New South Wales, Australia, 2150
Novartis Investigational Site
Sydney, New South Wales, Australia, 2000
Novartis Investigative Site
Westmead, New South Wales, Australia, 2145
Australia, Victoria
Novartis Investigative Site
East Melbourne, Victoria, Australia, 3002
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Customer Information Novartis
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00138632     History of Changes
Other Study ID Numbers: CPTK787E2201
First Posted: August 30, 2005    Key Record Dates
Last Update Posted: November 14, 2008
Last Verified: November 2008

Keywords provided by Novartis:
Wet Age-related macular degeneration
PTK787

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
 Pathologic Processes
Choroid Diseases
Uveal Diseases
Vatalanib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action