Safety and Efficacy of Oral PTK787 in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration (AMD)
Information source: Novartis
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Wet Age-Related Macular Degeneration
Intervention: PTK787 (Drug); PTK787 (Drug); Placebo (Drug)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s): Novartis Customer Information, Study Chair, Affiliation: Novartis
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Safety as assessed by visual acuity measurements, ophthalmic examinations, vital signs, laboratory assessments, and adverse events up to 12 months
Secondary outcome: 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
Eligibility
Minimum age: 65 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Retina-Vitreous Associates Medical Group, Beverly Hills, California 90211, United States
Porter Adventist Hospital, Eye Lab, Denver, Colorado 80210, United States
USF Eye Institute, Tampa, Florida 33612-4742, United States
Springfield Clinic, LLP, Springfield, Illinois 62701, United States
Wilmer Eye Institute, Baltimore, Maryland 21287, United States
Lahey Clinic Medical Center, Eye institute, Peabody, Massachusetts 01960, United States
Novartis Investigative Site, Parramatta, New South Wales 2150, Australia
Novartis Investigational Site, Sydney, New South Wales 2000, Australia
Novartis Investigative Site, Westmead, New South Wales 2145, Australia
Black Hills Regional Eye Institute, Rapid City, South Dakota 05770, United States
Novartis Investigative Site, East Melbourne, Victoria 3002, Australia
Additional Information
Starting date: September 2005
Last updated: November 12, 2008
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