Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Patients With Diabetic Macular Edema

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT01363440
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

The purpose of this study is to determine the efficacy of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) on the best corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy study (ETDRS) chart in patients with diabetic macular edema (DME) with central involvement.

Key Dates

Start date
May 31, 2011
Status verified
Apr 2016
Primary completion
Jan 31, 2013
Completion
Nov 30, 2014

Study Design

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

Arms

  • Active Comparator: Macular Laser Photocoagulation Treatment (Control)
    Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
  • Experimental: Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4
    Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
  • Experimental: Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8
    Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.

Primary Outcome Measure

Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - Last Observation Carried Forward (LOCF) [ Time Frame: Baseline and Week 52 ]

Locations (51)

FacilityCityStateZIPSite coordinators
-PhoenixArizona--
-TucsonArizona--
-ArcadiaCalifornia--
-Beverly HillsCalifornia--
-La JollaCalifornia--
-Mountain ViewCalifornia--
-OaklandCalifornia--
-Palm DesertCalifornia--
-SacramentoCalifornia--
-San FranciscoCalifornia--
-Santa BarbaraCalifornia--
-TorranceCalifornia--
-Colorado SpringsColorado--
-GoldenColorado--
-New LondonConnecticut--
-Fort LauderdaleFlorida--
-Fort MyersFlorida--
-MiamiFlorida--
-OrlandoFlorida--
-Winter HavenFlorida--
-AugustaGeorgia--
-‘AieaHawaii--
-WichitaKansas--
-PortlandMaine--
-BaltimoreMaryland--
-BostonMassachusetts--
-MissoulaMontana--
-Las VegasNevada--
-New BrunswickNew Jersey--
-NorthfieldNew Jersey--
-TeaneckNew Jersey--
-LynbrookNew York--
-Orchard ParkNew York--
-RochesterNew York--
-AshevilleNorth Carolina--
-CharlotteNorth Carolina--
-RaleighNorth Carolina--
-PortlandOregon--
-KingstonPennsylvania--
-PittsburghPennsylvania--
-FlorenceSouth Carolina--
-West ColumbiaSouth Carolina--
-Rapid CitySouth Dakota--
-NashvilleTennessee--
-AbileneTexas--
-AustinTexas--
-HarlingenTexas--
-HoustonTexas--
-San Antonio (2 Locations)Texas--
-The WoodlandsTexas--
-Salt Lake CityUtah--

Find similar trials in Phoenix, AZ

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina

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