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LFG316

Phase 1

Advanced Age-related Macular Degeneration | Monoclonal antibody | Ophthalmology |Novartis AG|Last Updated: May 1, 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01255462Intravitreal LFG316 in Patients With Advanced Age-related Macular DegenerationPHASE1 COMPLETED 24Nov 1, 2010Sep 1, 2011May 1, 20128 United States
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Study Endpoints
Primary Endpoints
To evaluate the safety and tolerability of single intravitreal doses of LFG316 in patients with advanced age-related macular degeneration.
Day 1 to Day 85 (starting from the day of intravitreal injection until the end of the study)
Secondary Endpoints
To evaluate the serum pharmacokinetic profile of single intravitreal doses of LFG316 in patients with advanced age-related macular degeneration.
Day 1 to Day 85 (starting from the day of intravitreal injection until the end of the study)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LFG316 0.15mgEXPERIMENTAL -
LFG316 0.5mgEXPERIMENTAL -
LFG316 1.5mgEXPERIMENTAL -
LFG316 5mgEXPERIMENTAL -
Interventions
NameTypeDescription
LFG316BIOLOGICAL -
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Eligibility Criteria
Age Range55 Years — 90 Years
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Male or female AMD patients 55 to 90 years old, inclusive. In either eye, diagnosis of geographic atrophy or choroidal neovascularization due to AMD * ETDRS best corrected visual acuity of 60 letters or worse in the study eye. Exclusion Criteria: * Retinal disease other than...

Countries:United States
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