Safety and Efficacy of Oral PTK787 in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration (AMD) (ADVANCE)
This study has been completed.
Sponsor:
Novartis
ClinicalTrials.gov Identifier:
NCT00138632
First Posted: August 30, 2005
Last Update Posted: November 14, 2008
Information provided by:
Novartis
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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 Intervention Model: Parallel Assignment Masking: Triple (Participant, 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
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 ]
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 ]
| 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
Information from the National Library of Medicine
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 65 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
| First Submitted: | August 29, 2005 |
| First Posted: | August 30, 2005 |
| Last Update Posted: | November 14, 2008 |
| Last Verified: | November 2008 |
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 |