CompletedPhase 1/2

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

United States50 participantsStarted 2005-09

Plain-language 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.

Who can participate

Age range65 Years

SexALL

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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

What they're measuring

Safety as assessed by visual acuity measurements, ophthalmic examinations, vital signs, laboratory assessments, and adverse events up to 12 months

Timeframe: up to 12 months

Trial details

NCT IDNCT00138632

SponsorNovartis

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-11

View on ClinicalTrials.gov More Wet Age-Related Macular Degeneration trials