Wet Age-Related Macular Degeneration Clinical Trial
— ADVANCEOfficial 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
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | |
Est. primary completion date | November 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 65 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Novartis Investigative Site | East Melbourne | Victoria |
Australia | Novartis Investigative Site | Parramatta | New South Wales |
Australia | Novartis Investigational Site | Sydney | New South Wales |
Australia | Novartis Investigative Site | Westmead | New South Wales |
United States | Wilmer Eye Institute | Baltimore | Maryland |
United States | Retina-Vitreous Associates Medical Group | Beverly Hills | California |
United States | Porter Adventist Hospital, Eye Lab | Denver | Colorado |
United States | Lahey Clinic Medical Center, Eye institute | Peabody | Massachusetts |
United States | Black Hills Regional Eye Institute | Rapid City | South Dakota |
United States | Springfield Clinic, LLP | Springfield | Illinois |
United States | USF Eye Institute | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Novartis |
United States, Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety as assessed by visual acuity measurements, ophthalmic examinations, vital signs, laboratory assessments, and adverse events up to 12 months | up to 12 months | Yes | |
Secondary | 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 | Yes |
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