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

November 12, 2008 updated by: Novartis

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Parramatta, New South Wales, Australia, 2150
        • Novartis Investigative Site
      • Sydney, New South Wales, Australia, 2000
        • Novartis Investigational site
      • Westmead, New South Wales, Australia, 2145
        • Novartis Investigative Site
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Novartis Investigative Site
  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • Retina-Vitreous Associates Medical Group
    • Colorado
      • Denver, Colorado, United States, 80210
        • Porter Adventist Hospital, Eye Lab
    • Florida
      • Tampa, Florida, United States, 33612-4742
        • USF Eye Institute
    • Illinois
      • Springfield, Illinois, United States, 62701
        • Springfield Clinic, LLP
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Wilmer Eye Institute
    • Massachusetts
      • Peabody, Massachusetts, United States, 01960
        • Lahey Clinic Medical Center, Eye institute
    • South Dakota
      • Rapid City, South Dakota, United States, 05770
        • Black Hills Regional Eye Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: PTK787
Visudyne® + PTK787, 500 mg/day
Drug: PTK787
Visudyne® + PTK787 1000 mg/day
Experimental: 2
Drug: PTK787
Visudyne® + PTK787, 500 mg/day
Drug: PTK787
Visudyne® + PTK787 1000 mg/day
Placebo Comparator: 3
Drug: Placebo
Visudyne® + Placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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
Time Frame: from baseline up to 3 months
from baseline up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

August 29, 2005

First Submitted That Met QC Criteria

August 29, 2005

First Posted (Estimate)

August 30, 2005

Study Record Updates

Last Update Posted (Estimate)

November 14, 2008

Last Update Submitted That Met QC Criteria

November 12, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPTK787E2201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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