DME And VEGF Trap-Eye [Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)] INvestigation of Clinical Impact

Part of paid clinical trials in Artesia, California.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT00789477
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

This is a Phase 2, doubled-masked, randomized study of the efficacy and safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) in subjects with diabetic macular edema (DME). Approximately 200 subjects will be randomized in the US, Canada, Australia and EU.

Key Dates

Start date
Dec 31, 2008
Status verified
Aug 2014
Primary completion
Dec 31, 2009
Completion
Sep 30, 2010

Study Design

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

Arms

  • Experimental: Intravitreal Aflibercept Injection .5Q4
    Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) .5 mg every 4 weeks
  • Experimental: Intravitreal Aflibercept Injection 2Q4
    Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2 mg every 4 weeks
  • Experimental: Intravitreal Aflibercept Injection 2Q8
    Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2mg every 4 weeks for 3 visits followed by every 8 weeks
  • Experimental: Intravitreal Aflibercept Injection 2PRN
    Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2mg every 4 weeks for 3 visits followed by PRN (as-needed) dosing according to the re-treatment criteria
  • Active Comparator: Laser Photocoagulation
    Focal laser at week 1, and one week after visits at which the participant met laser re-treatment criteria to the end of the study (week 52) starting at week 16; laser re- treatment was permitted no more than once every 16 weeks.

Primary Outcome Measure

Change in BCVA From Baseline to Week 24 - Last Observation Carried Forward (LOCF) [ Time Frame: At week 24 ]

Locations (42)

FacilityCityStateZIPSite coordinators
-ArtesiaCalifornia90701-
-Beverly HillsCalifornia90211-
-Mountain ViewCalifornia94040-
-PasadenaCalifornia91105-
-SacramentoCalifornia95819-
-Santa AnaCalifornia92705-
-HamdenConnecticut06518-
-New LondonConnecticut06320-
-Boynton BeachFlorida33426-
-Fort LauderdaleFlorida33334-
-Fort MyersFlorida33912-
-OcalaFlorida34474-
-Palm Beach GardensFlorida33410-
-Winter HavenFlorida33880-
-AugustaGeorgia30909-
-HonoluluHawaii96815-
-IndianapolisIndiana46280-
-BangorMaine04401-
-BaltimoreMaryland21287-
-BostonMassachusetts02114-
-JacksonMichigan48104-
-Kansas CityMissouri64108-
-LincolnNebraska68506-
-New BrunswickNew Jersey08901-
-NorthfieldNew Jersey08225-
-Toms RiverNew Jersey08753-
-RochesterNew York14620-
-CharlotteNorth Carolina28210-
-RaleighNorth Carolina27607-
-CincinnatiOhio45243-
-PittsburghPennsylvania15213-
-GreenvilleSouth Carolina29605-
-West ColumbiaSouth Carolina29169-
-NashvilleTennessee37203-
-AbileneTexas79606-
-ArlingtonTexas76012-
-AustinTexas78705-
-HoustonTexas77030-
-McAllenTexas78503-
-San AntonioTexas78215-
-San AntonioTexas78240-
-Salt Lake CityUtah84107-

Find similar trials in Artesia, CA

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina

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