Safety, Tolerability, and Efficacy of Aflibercept in Patients With Neovascular Age-Related Macular Degeneration

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT04126317
Phase
PHASE2
Status
Completed

Conditions

  • Neovascular (Wet) Age-Related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • aflibercept — DRUG
    Intravitreally (IVT) administered as a liquid formulation in a vial
  • High-dose aflibercept — DRUG
    Intravitreally (IVT) administered as a liquid formulation in a vial

Study Details

The primary objectives of the study are to determine the safety of high-dose aflibercept (hereafter referred to as HD) and to determine if HD provides greater intraocular pharmacodynamic (PD) effect and/or longer duration of action compared to intravitreal aflibercept injection (hereafter referred to as IAI).

Key Dates

Start date
Nov 4, 2019
Status verified
Jul 2023
Primary completion
May 14, 2021
Completion
Nov 30, 2021

Study Design

Enrollment
106 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: intravitreal aflibercept injection (IAI)
    Treatment-naïve patients with neovascular "wet" age-related macular degeneration (nAMD) randomized in a 1:1 ratio
  • Experimental: High-dose aflibercept (HD)
    Treatment-naïve patients with nAMD randomized in a 1:1 ratio

Primary Outcome Measure

Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) [ Time Frame: Up to Week 44 ]

Locations (45)

FacilityCityStateZIPSite coordinators
Regeneron Study SitePhoenixArizona85020-
Regeneron Study SiteSun CityArizona85351-
Regeneron Study SiteEncinoCalifornia91436-
Regeneron Study SiteFullertonCalifornia92835-
Regeneron Study SiteMountain ViewCalifornia94040-
Regeneron Study SitePalm DesertCalifornia92211-
Regeneron Study SiteSacramentoCalifornia95819-
Regeneron Study SiteSanta AnaCalifornia92705-
Regeneron Study SiteColorado SpringsColorado80909-
Regeneron Study SiteGoldenColorado80401-
Regeneron Study SiteWaterfordConnecticut06385-
Regeneron Study SiteFort LauderdaleFlorida33309-
Regeneron Study SiteFort MyersFlorida33912-
Regeneron Study SiteLakelandFlorida33805-
Regeneron Study SiteLargoFlorida33770-
Regeneron Study SiteMelbourneFlorida32901-
Regeneron Study SiteTallahasseeFlorida32308-
Regeneron Study SiteWinter HavenFlorida33880-
Regeneron Study SiteAugustaGeorgia30909-
Regeneron Study SiteMariettaGeorgia30060-
Regeneron Study SiteOak ForestIllinois60452-
Regeneron Study SiteHagerstownMaryland21740-
Regeneron Study SiteRoyal OakMichigan48073-
Regeneron Study SiteBloomfieldNew Jersey07003-
Regeneron Study SiteTeaneckNew Jersey07666-
Regeneron Study SiteAlbuquerqueNew Mexico87102-
Regeneron Study SiteGreat NeckNew York11021-
Regeneron Study SiteAshevilleNorth Carolina28803-
Regeneron Study SiteCharlotteNorth Carolina28210-
Regeneron Study SiteColumbusOhio43212-
Regeneron Study SiteEdmondOklahoma73013-
Regeneron Study SitePortlandOregon97221-
Regeneron Study SiteKingstonPennsylvania18704-
Regeneron Study SiteLadsonSouth Carolina29456-
Regeneron Study SiteWest ColumbiaSouth Carolina29169-
Regeneron Study SiteRapid CitySouth Dakota57701-
Regeneron Study SiteAbileneTexas79606-
Regeneron Study SiteArlingtonTexas76012-
Regeneron Study SiteAustinTexas78705-
Regeneron Study SiteHoustonTexas77030-
Regeneron Study SiteThe WoodlandsTexas77384-
Regeneron Study SiteSalt Lake CityUtah84107-
Regeneron Study SiteFairfaxVirginia22031-
Regeneron Study SiteSpokaneWashington99204-
Regeneron Study SiteMorgantownWest Virginia26506-

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