Status:
COMPLETED
Safety and Efficacy of Oral PTK787 in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration (AMD)
Lead Sponsor:
Novartis
Conditions:
Wet Age-Related Macular Degeneration
Eligibility:
All Genders
65+ years
Phase:
PHASE1
PHASE2
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. I...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00138632
Start Date
September 1 2005
Last Update
November 14 2008
Active Locations (11)
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1
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
2
Porter Adventist Hospital, Eye Lab
Denver, Colorado, United States, 80210
3
USF Eye Institute
Tampa, Florida, United States, 33612-4742
4
Springfield Clinic, LLP
Springfield, Illinois, United States, 62701