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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Wet Age-Related Macular Degeneration

In brief

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.

Key facts

Study ID

NCT00138632

Run by

Novartis

People needed

50

Starts

2005-09-01

Last updated by the study team

2008-11-14

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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