Clinical trial NCT00138632: Safety and Efficacy of Oral PTK787 in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration (AMD)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Wet Age-Related Macular Degeneration
Keywords: Wet Age-related macular degeneration
PTK787
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-08-30
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Safety as assessed by visual acuity measurements, ophthalmic examinations, vital signs, laboratory assessments, and adverse events up to 12 months
timeFrame: up to 12 months
Secondary outcomes:
measure: 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
timeFrame: from baseline up to 3 months
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Retina-Vitreous Associates Medical Group
state: California
city: Denver
country: United States
facility: Porter Adventist Hospital, Eye Lab
state: Colorado
city: Tampa
country: United States
facility: USF Eye Institute
state: Florida
city: Springfield
country: United States
facility: Springfield Clinic, LLP
state: Illinois
city: Baltimore
country: United States
facility: Wilmer Eye Institute
state: Maryland
city: Peabody
country: United States
facility: Lahey Clinic Medical Center, Eye institute
state: Massachusetts
city: Rapid City
country: United States
facility: Black Hills Regional Eye Institute
state: South Dakota
city: Parramatta
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Sydney
country: Australia
facility: Novartis Investigational Site
state: New South Wales
city: Westmead
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: East Melbourne
country: Australia
facility: Novartis Investigative Site
state: Victoria
Study officials:
affiliation: Novartis
name: Novartis Customer Information
role: STUDY_CHAIR
References: