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Aflibercept monthly

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment9

FDA Designations

PRIORITY_REVIEW

Clinical trial landscape

Aflibercept monthly · 1 trial · 2 indications

Phase 1 1
NCT01579760Intravitreal Aflibercept Injection for Radiation RetinopathyRadiation Retinopathy
COMPLETED9 Analytics
PHASE1COMPLETED
Intravitreal Aflibercept Injection for Radiation Retinopathy
Radiation Retinopathy
NCT015797609
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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
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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)
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Eligibility Criteria

Age Range18 Years to 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
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