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
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00138632
First received: August 29, 2005
Last updated: November 12, 2008
Last verified: November 2008
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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 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
X-linked juvenile retinoschisis
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 |
| 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
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
No publications provided
| 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 Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013