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VEGF Trap

Phase 1

Neovascular Age Related Macular Degeneration | Small molecule | Ophthalmology |Regeneron Pharmaceuticals, Inc.|Last Updated: Apr 21, 2011

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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00383370Safety and Tolerability of Intravitreal VEGF Trap Formulations in Subjects With Neovacular AMDPHASE1 COMPLETED 20Oct 1, 2006Jul 1, 2008Apr 21, 20116 United States
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Study Endpoints
Primary Endpoints
The primary endpoint of the study will be safety and tolerability of the study treatment at Week 12 as assessed by ophthalmic examination and reporting of AEs.
12 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ITV-1EXPERIMENTALVEGF Trap formulation 1
ITV-2EXPERIMENTALVEGF Trap formulation 2
ITV-2 OLEXPERIMENTALVEGF Trap formulation 2 open label, higher concentration
Interventions
NameTypeDescription
VEGF TrapDRUGVEGF Trap formulation 1, ITV-1
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Eligibility Criteria
Age Range50 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Subfoveal CNV secondary to AMD. * Central retinal (including lesion) thickness ≥ 250 µm as measured by OCT. * ETDRS best-corrected visual acuity (BCVA) of 20/40 to 20/400 (73 to 20 letters) Exclusion Criteria: * No prior treatment with the following in the study eye: * Su...

Countries:United States
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