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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00138632
First received: August 29, 2005
Last updated: November 12, 2008
Last verified: November 2008

August 29, 2005
November 12, 2008
September 2005
November 2007   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
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Complete list of historical versions of study NCT00138632 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
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Safety and Efficacy of Oral PTK787 in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration (AMD)
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

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Wet Age-Related Macular Degeneration
  • Drug: PTK787
    Visudyne® + PTK787, 500 mg/day
  • Drug: PTK787
    Visudyne® + PTK787 1000 mg/day
  • Drug: Placebo
    Visudyne® + Placebo
  • Experimental: 1
    Intervention: Drug: PTK787
  • Experimental: 2
    Intervention: Drug: PTK787
  • Placebo Comparator: 3
    Intervention: Drug: Placebo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
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November 2007   (final data collection date for primary outcome measure)

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

Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia
 
NCT00138632
CPTK787E2201
Not Provided
External Affairs, Novartis Pharmaceuticals
Novartis
Not Provided
Study Chair: Novartis Customer Information Novartis
Novartis
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP