NCT00138632

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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Geographic Reach
2 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2005

Completed
2 days until next milestone

Study Start

First participant enrolled

September 1, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Last Updated

November 14, 2008

Status Verified

November 1, 2008

Enrollment Period

2.2 years

First QC Date

August 29, 2005

Last Update Submit

November 12, 2008

Conditions

Wet Age-Related Macular Degeneration

Keywords

Wet Age-related macular degenerationPTK787

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (3)

1

EXPERIMENTAL
Drug: PTK787

2

EXPERIMENTAL
Drug: PTK787

3

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PTK787DRUG

Visudyne® + PTK787, 500 mg/day

1
PlaceboDRUG

Visudyne® + Placebo

3

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Male ≥ 65 years old or female ≥ 50 years old, with aged related macular degeneration
  • Patients with subfoveal choroidal neovascularization secondary to AMD

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

Porter Adventist Hospital, Eye Lab

Denver, Colorado, 80210, United States

Location

USF Eye Institute

Tampa, Florida, 33612-4742, United States

Location

Springfield Clinic, LLP

Springfield, Illinois, 62701, United States

Location

Wilmer Eye Institute

Baltimore, Maryland, 21287, United States

Location

Lahey Clinic Medical Center, Eye institute

Peabody, Massachusetts, 01960, United States

Location

Black Hills Regional Eye Institute

Rapid City, South Dakota, 05770, United States

Location

Novartis Investigative Site

Parramatta, New South Wales, 2150, Australia

Location

Novartis Investigational Site

Sydney, New South Wales, 2000, Australia

Location

Novartis Investigative Site

Westmead, New South Wales, 2145, Australia

Location

Novartis Investigative Site

East Melbourne, Victoria, 3002, Australia

Location

MeSH Terms

Interventions

vatalanib

Study Officials

  • Novartis Customer Information

    Novartis

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 29, 2005

First Posted

August 30, 2005

Study Start

September 1, 2005

Primary Completion

November 1, 2007

Last Updated

November 14, 2008

Record last verified: 2008-11

Locations

US(7)AU(4)