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PTK787

Phase 1

Wet Age-Related Macular Degeneration | Small molecule | Ophthalmology |Novartis AG|Last Updated: Nov 14, 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

PTK787 · 1 trial · 1 indication

Phase 1 1
NCT00138632Safety and Efficacy of Oral PTK787 in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration (AMD)Wet Age-Related Macular Degeneration
COMPLETED50 Analytics
PHASE1COMPLETED
Safety and Efficacy of Oral PTK787 in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration (AMD)
Wet Age-Related Macular DegenerationUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety as assessed by visual acuity measurements, ophthalmic examinations, vital signs, laboratory assessments, and adverse events up to 12 months
up to 12 months

Secondary Endpoints

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
from baseline up to 3 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
PTK787DRUGVisudyne® + PTK787, 500 mg/day
PlaceboDRUGVisudyne® + Placebo
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Eligibility Criteria

Age Range65 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites11

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, de...

Countries:United StatesAustralia
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Frequently asked questions about PTK787

What is PTK787 used for?

PTK787 is an investigational small molecule being studied for Von Hippel-Lindau Disease, wet age-related macular degeneration, and tumors. It has been evaluated in clinical trials for these conditions, including retinal and CNS hemangioblastoma related to VHL disease.

Who makes PTK787?

PTK787 is being developed by Novartis AG (NVS). The company has sponsored clinical trials of the drug for conditions including Von Hippel-Lindau Disease and wet age-related macular degeneration.

What phase is PTK787 in?

PTK787 is an investigational drug that has completed clinical trials. It has been studied in Phase 1 and Phase 2 trials, but it is not approved by the FDA and remains in clinical development.

What clinical trials is PTK787 in?

PTK787 has been studied in completed trials including NCT00052013 for Von Hippel-Lindau Disease, NCT00138632 for wet age-related macular degeneration, and NCT00171587 for advanced tumors. These trials are all completed.

Is PTK787 the same as vatalanib?

PTK787 is also known as vatalanib. In clinical trials, it has been referred to as PTK787/ZK 222584 and vatalanib, including in studies of advanced cancer.