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

Novartis

Status and phase: Completed; Phase 2; Phase 1

Conditions: Wet Age-Related Macular Degeneration

Treatments: Drug: PTK787; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00138632

CPTK787E2201

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 3 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: PTK787

Drug: PTK787

2

Experimental group

Treatment:

Drug: PTK787

Drug: PTK787

3

Placebo Comparator group

Treatment:

Drug: Placebo