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Aflibercept every 2 months

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 every 2 months · 1 trial · 2 indications

Phase 1 1
NCT01579760Intravitreal Aflibercept Injection for Radiation RetinopathyRadiation Retinopathy
COMPLETED9 Analytics
PHASE1COMPLETED
Intravitreal Aflibercept Injection for Radiation Retinopathy
Radiation RetinopathyUnlock trial analytics

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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Frequently asked questions about Aflibercept every 2 months

What is Aflibercept every 2 months used for?

Aflibercept every 2 months is used for radiation retinopathy, a condition that can cause macular edema. It is administered via intravitreal injection and is being studied in the ophthalmology therapeutic area. The drug is a small molecule developed by Regeneron Pharmaceuticals.

Who makes Aflibercept every 2 months?

Aflibercept every 2 months is developed by Regeneron Pharmaceuticals, Inc., which trades under the ticker REGN. The company is conducting clinical research on this drug for the treatment of radiation retinopathy.

What phase is Aflibercept every 2 months in?

Aflibercept every 2 months is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The drug has received a priority review designation from the FDA, indicating it is being evaluated for expedited review.

What clinical trials is Aflibercept every 2 months in?

Aflibercept every 2 months has one completed clinical trial, NCT01579760, titled "Intravitreal Aflibercept Injection for Radiation Retinopathy." This Phase 1 trial enrolled 9 participants in the United States and studied the drug's effects on radiation retinopathy and macular edema.

Is Aflibercept every 2 months the same as Aflibercept?

Aflibercept every 2 months is a dosing regimen of aflibercept, a medication that blocks vascular endothelial growth factor (VEGF). The every 2 months schedule refers to the frequency of administration, which is being evaluated in clinical trials for radiation retinopathy.