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verteporfin

Phase 1

Choroidal Neovascularization | Small molecule | Ophthalmology |Atlantic International Corp.|Last Updated: Jul 10, 2012

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-BlindCONTROLLED
Total Trials1
Total Enrollment41
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00570193Photodynamic and Pharmacologic Treatment of CNVPHASE1 COMPLETED 41Dec 1, 2006Jun 1, 2011Jul 10, 2012 -
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Study Endpoints
Primary Endpoints
Visual change
18 months
Secondary Endpoints
Frequency of treatment
18 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
IEXPERIMENTALCombined treatment with verteporfin (Visudyne) and ranibizumab (Lucentis)
IIEXPERIMENTALTreatment with ranibizumab (Lucentis)
Interventions
NameTypeDescription
verteporfin (Visudyne)DRUGVerteporfin (Visudyne) 6 mg/m2 at 300mW/cm2 given on week O and then at week 5, given as indicated per protocol; ranibizumab (Lucentis) 0.3 mg given at week 1
ranibizumab (Lucentis)DRUGranibizumab (Lucentis) 0.3 mg on weeks 1,5,9,13,17,21,25,29,33\&37 per study protocol
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Eligibility Criteria
SexALL
Healthy VolunteersNo

Inclusion Criteria: * All previously untreated CNV secondary to MD

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