Anti-vasculaR Endothelial Growth Factor plUs Anti-angiopoietin 2 in Fixed comBination therapY: Evaluation for the Treatment of Diabetic Macular Edema

Part of paid clinical trials in Mesa, Arizona.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT02712008
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

The primary objective of the study was to compare the efficacy of intravitreal (IVT)-administered REGN910-3 compared to intravitreal aflibercept injection (IAI) in improving best corrected visual acuity (BCVA) in participants with diabetic macular edema (DME).

Key Dates

Start date
Mar 2, 2016
Status verified
Oct 2018
Primary completion
Jul 10, 2017
Completion
Jul 10, 2017

Study Design

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

Arms

  • Experimental: REGN910-3 (3 mg: 2 mg)
    Participants were administered intravitreal injection of REGN910-3 (3 milligram (mg):2 mg) every 4 weeks (Q4) on Day 1, Week 4, and Week 8 for 3 initial doses followed by every Week 8 (Q8) dosing beginning at Week 16 up to Week 32.
  • Experimental: REGN910-3 (6 mg:2 mg)
    Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to week 12.
  • Active Comparator: Aflibercept 2 mg
    Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12.
  • Experimental: REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q8
    Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At Week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) at Week 16 and Q8 through Week 32.
  • Experimental: REGN910-3 (6 mg:2 mg) Q4 to REGN910-3 (6 mg:2 mg) Q12
    Participants were administered intravitreal injection of REGN910-3 (6 mg:2 mg) Q4 on Day 1, Week 4 and Week 8 for 3 initial doses. At week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) at Week 20 and Q12 through Week 32.
  • Experimental: Aflibercept 2 mg Q4 to Aflibercept 2 mg Q8
    Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI at Week16 and Q8 through Week 32.
  • Experimental: Aflibercept 2 mg Q4 to Aflibercept 2 mg Q12
    Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At Week 12, participants were re-randomized to receive IAI at Week 20 and Q12 through Week 32.
  • Experimental: Aflibercept 2 mg Q4 to REGN910-3 (6 mg:2 mg) Q8
    Participants were administered intravitreal injection of Aflibercept (IAI) 2 mg Q4 on Day 1, Week 4 and Week 8 for 3 initial doses up to Week 12. At week 12, participants were re-randomized to receive REGN910-3 (6 mg:2 mg) at week 16 and Q8 through week 32.

Primary Outcome Measure

Change From Baseline in Best Corrected Visual Acuity (BCVA) Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 12 [ Time Frame: Baseline, Week 12 ]

Locations (51)

FacilityCityStateZIPSite coordinators
-MesaArizona--
-TucsonArizona--
-ArcadiaCalifornia--
-Beverly HillsCalifornia--
-Mountain ViewCalifornia--
-OceansideCalifornia--
-Palm DesertCalifornia--
-Colorado SpringsColorado--
-New LondonConnecticut--
-LakelandFlorida--
-TampaFlorida--
-Winter HavenFlorida--
-AugustaGeorgia--
-DecaturGeorgia--
-‘AieaHawaii--
-ChicagoIllinois--
-New AlbanyIndiana--
-Shawnee MissionKansas--
-LexingtonKentucky--
-PortlandMaine--
-BaltimoreMaryland--
-RockvilleMaryland--
-BostonMassachusetts--
-Grand RapidsMichigan--
-JacksonMichigan--
-MinneapolisMinnesota--
-FlorissantMissouri--
-Las VegasNevada--
-BloomfieldNew Jersey--
-EdisonNew Jersey--
-TeaneckNew Jersey--
-AlbanyNew York--
-RochesterNew York--
-AshevilleNorth Carolina--
-CharlotteNorth Carolina--
-KingstonPennsylvania--
-FlorenceSouth Carolina--
-West ColumbiaSouth Carolina--
-Rapid CitySouth Dakota--
-GermantownTennessee--
-NashvilleTennessee--
-AbileneTexas--
-AustinTexas--
-DallasTexas--
-Fort WorthTexas--
-HarlingenTexas--
-HoustonTexas--
-San AntonioTexas--
-The WoodlandsTexas--
-Willow ParkTexas--
-BellevueWashington--

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By condition
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By specialty
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