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PTK787

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment50
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00138632Safety and Efficacy of Oral PTK787 in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration (AMD)PHASE1 COMPLETED 50Sep 1, 2005 -Nov 14, 200811 United States, Australia
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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 — 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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