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

Purpose

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.

Condition	Intervention	Phase
Wet Age-Related Macular Degeneration	Drug: PTK787 Drug: Placebo	Phase 1 Phase 2


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

Resource links provided by NLM:

Genetics Home Reference related topics: age-related macular degeneration

MedlinePlus related topics: Macular Degeneration

Genetic and Rare Diseases Information Center resources: Uveal Diseases

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]


Enrollment:	50
Study Start Date:	September 2005
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: PTK787 Visudyne® + PTK787, 500 mg/day
Experimental: 2	Drug: PTK787 Visudyne® + PTK787 1000 mg/day
Placebo Comparator: 3	Drug: Placebo Visudyne® + Placebo

Eligibility


Ages Eligible for Study:	65 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00138632

Locations


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

Sponsors and Collaborators

Novartis

Investigators


Study Chair:	Novartis Customer Information	Novartis

More Information


Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00138632 History of Changes
Other Study ID Numbers:	CPTK787E2201
Study First Received:	August 29, 2005
Last Updated:	November 12, 2008
Health Authority:	United States: Food and Drug Administration Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Novartis:


Wet Age-related macular degeneration PTK787

Additional relevant MeSH terms:


Macular Degeneration Neovascularization, Pathologic Choroidal Neovascularization Retinal Degeneration Retinal Diseases Eye Diseases Metaplasia	Pathologic Processes Choroid Diseases Uveal Diseases Vatalanib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 29, 2016

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