Recent Updates
Recently added Catalysts

Aflibercept every 2 months

Phase 1

Radiation Retinopathy | Small molecule | Other |Regeneron Pharmaceuticals, Inc.|Last Updated: Apr 25, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment9
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01579760Intravitreal Aflibercept Injection for Radiation RetinopathyPHASE1 COMPLETED 9Nov 1, 2012Mar 27, 2019Apr 25, 20192 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Incidence of adverse events
12 months
Severity of adverse events
12 months
Secondary Endpoints
Mean change in best corrected visual acuity from baseline
12 months
Mean change in central foveal thickness by optical coherence tomography (OCT) from baseline
12 months
Mean visual acuity
12 months
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
aflibercept every 2 monthsEXPERIMENTAL -
aflibercept monthlyEXPERIMENTAL -
Interventions
NameTypeDescription
Aflibercept every 2 monthsDRUG2.0 mg aflibercept intravitreal injections once per month for the first 3 months (M0, M1, M2), then every 2 months (M4, M6, M8, M10)
Aflibercept monthlyDRUG2.0mg aflibercept intravitreal injections every month (M0-11)
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Retinopathy associated with previous I-125 brachytherapy for uveal melanoma (85 Gy over 96 hours) at least 6 months prior to enrollment * Ability to provide written informed consent and comply with study assessments for the full duration of the study * Age \> 18 years * Center...

Countries:United States
Unlock Eligibility Criteria