Safety and Efficacy of Oral PTK787 in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration (AMD) (ADVANCE)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00138632 |
Recruitment Status :
Completed
First Posted : August 30, 2005
Last Update Posted : November 14, 2008
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 or disease | Intervention/treatment | Phase |
---|---|---|
Wet Age-Related Macular Degeneration | Drug: PTK787 Drug: Placebo | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 50 participants |
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 |
Study Start Date : | September 2005 |
Actual Primary Completion Date : | November 2007 |

Arm | Intervention/treatment |
---|---|
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 |
- 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 ]
- 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 ]

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 (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
Study Chair: | Novartis Customer Information | Novartis |
Responsible Party: | External Affairs, Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00138632 History of Changes |
Other Study ID Numbers: |
CPTK787E2201 |
First Posted: | August 30, 2005 Key Record Dates |
Last Update Posted: | November 14, 2008 |
Last Verified: | November 2008 |
Wet Age-related macular degeneration PTK787 |
Macular Degeneration Choroidal Neovascularization Neovascularization, Pathologic Retinal Degeneration Retinal Diseases Eye Diseases Metaplasia |
Pathologic Processes Choroid Diseases Uveal Diseases Vatalanib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |