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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00138632

Acronym

ADVANCE

Enrollment

Registered

2005-08-30

Start date

2005-09-30

Completion date

Unknown

Last updated

2008-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wet Age-Related Macular Degeneration

Keywords

Wet Age-related macular degeneration, PTK787

Brief 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.

Interventions

DRUGPTK787

Visudyne® + PTK787, 500 mg/day

DRUGPlacebo

Visudyne® + Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Australia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026