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

Wet Age-Related Macular Degeneration Clinical Trial

— ADVANCE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00138632
• Other study ID #: CPTK787E2201
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 29, 2005
• Last updated: November 12, 2008
• Start date: September 2005

Study information

• Verified date: November 2008
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Macular Degeneration
• Neovascularization, Pathologic
• Wet Age-Related Macular Degeneration

Intervention

Drug:
• PTK787
Visudyne® + PTK787, 500 mg/day
• PTK787
Visudyne® + PTK787 1000 mg/day
• Placebo
Visudyne® + Placebo

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	East Melbourne	Victoria
Australia	Novartis Investigative Site	Parramatta	New South Wales
Australia	Novartis Investigational Site	Sydney	New South Wales
Australia	Novartis Investigative Site	Westmead	New South Wales
United States	Wilmer Eye Institute	Baltimore	Maryland
United States	Retina-Vitreous Associates Medical Group	Beverly Hills	California
United States	Porter Adventist Hospital, Eye Lab	Denver	Colorado
United States	Lahey Clinic Medical Center, Eye institute	Peabody	Massachusetts
United States	Black Hills Regional Eye Institute	Rapid City	South Dakota
United States	Springfield Clinic, LLP	Springfield	Illinois
United States	USF Eye Institute	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

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