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REGN2176-3

Phase 1

Neovascular Wet Age-related Macular Degeneration (AMD) | Small molecule | Ophthalmology |Regeneron Pharmaceuticals, Inc.|Last Updated: Feb 11, 2015

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

REGN2176-3 · 1 trial · 1 indication

Phase 1 1
NCT02061865Phase 1 Safety Study With Intravitreal (IVT) REGN2176-3 in Patients Aged 50 Years and Older With Wet AMDNeovascular Wet Age-related Macular Degeneration (AMD)
COMPLETED12 Analytics
PHASE1COMPLETED
Phase 1 Safety Study With Intravitreal (IVT) REGN2176-3 in Patients Aged 50 Years and Older With Wet AMD
Neovascular Wet Age-related Macular Degeneration (AMD)Unlock trial analytics

Study Endpoints

Primary Endpoints

Safety
day 1 through week 24

The primary endpoint in the study is the incidence of treatment emergent adverse events (TEAEs) from day 1 through week 24 in patients treated with IVT REGN2176-3.

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohorts 1 - 4EXPERIMENTALParticipants in cohort 1 will receive REGN2176-3 dosing regimen 1. Participants in cohort 2 will receive REGN2176-3 dosing regimen 2. Participants in cohort 3 will receive REGN2176-3 dosing regimen 3. Participants in cohort 4 will receive REGN2176-3 dosing regimen 4.

Interventions

NameTypeDescription
REGN2176-3DRUG -
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Eligibility Criteria

Age Range50 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: Key Criteria: Men or women greater than or equal to 50 years of age who provide informed consent and have active subfoveal choroidal neovascularization (CNV) secondary to wet AMD. Exclusion Criteria: 1. Any prior treatment with an inhibitor of PDGF (platelet-derived growth fa...

Countries:United States
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Frequently asked questions about REGN2176-3

What is REGN2176-3 used for?

REGN2176-3 is an investigational small molecule being developed for the treatment of neovascular wet age-related macular degeneration (AMD), a condition that causes abnormal blood vessel growth in the eye leading to vision loss. It is administered via intravitreal injection and is currently in Phase 1 clinical development.

Who makes REGN2176-3?

REGN2176-3 is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol REGN. The company is conducting clinical trials to evaluate the safety and tolerability of this investigational therapy for wet AMD.

What phase is REGN2176-3 in?

REGN2176-3 is in Phase 1 clinical development. A Phase 1 safety study has been completed, and the drug remains investigational, meaning it has not been approved by regulatory authorities. Further clinical trials would be needed to establish its safety and efficacy for wet AMD.

What clinical trials is REGN2176-3 in?

REGN2176-3 has been studied in one clinical trial, identified as NCT02061865. This was a Phase 1 safety study conducted in the United States with 12 participants aged 50 years and older with wet AMD. The trial has been completed and was not randomized or double-blinded.

How is REGN2176-3 administered?

REGN2176-3 is administered via intravitreal injection, meaning it is injected directly into the vitreous humor of the eye. This route of administration is commonly used for treatments targeting retinal diseases like wet age-related macular degeneration to deliver the drug locally to the affected tissue.