CompletedPhase 1/2

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

United States, Australia50 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 range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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