A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Lucentis® Monotherapy

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Ophthotech Corporation
Study ID
NCT01944839
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • E10030 — DRUG
  • ranibizumab — DRUG
  • E10030 sham intravitreal injection — DRUG
    Pressure on the eye with a syringe with no needle

Study Details

The objectives of this study are to evaluate the safety and efficacy of intravitreal administration of Fovista® administered in combination with Lucentis® compared to Lucentis® monotherapy in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).

Key Dates

First listed
Sep 18, 2013
Start date
Aug 31, 2013
Status verified
Aug 2018
Primary completion
Dec 31, 2016
Completion
Dec 31, 2016

Study Design

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

Arms

  • Experimental: E10030 + ranibizumab
    E10030 1.5 mg intravitreal injection + ranibizumab 0.5 mg intravitreal injection
  • Active Comparator: Sham + ranibizumab
    E10030 sham intravitreal injection + ranibizumab 0.5 mg intravitreal injection

Primary Outcome Measure

Mean Change in Visual Acuity From Baseline to 12 Months [ Time Frame: 12 Months ]

Locations (50)

FacilityCityStateZIPSite coordinators
-PhoenixArizona85014-
-BakersfieldCalifornia93309-
-Beverly HillsCalifornia90211-
-Los AngelesCalifornia90095-
-San FranciscoCalifornia94107-
-Santa BarbaraCalifornia93103-
-Colorado SpringsColorado80909-
-BridgeportConnecticut06606-
-New LondonConnecticut06320-
-Altamonte SpringsFlorida32701-
-Fort MyersFlorida33907-
-SarasotaFlorida34233-
-TampaFlorida33609-
-TampaFlorida33612-
-Winter HavenFlorida33880-
-MariettaGeorgia30060-
-SpringfieldIllinois62704-2173-
-IndianapolisIndiana46290-
-LeawoodKansas66211-
-LexingtonKentucky40509-
-LexingtonKentucky40536-
-LouisvilleKentucky40202-
-New OrleansLouisiana70121-
-Chevy ChaseMaryland20815-
-BostonMassachusetts02111-
-BostonMassachusetts02114-
-JacksonMichigan49202-
-SouthfieldMichigan48034-
-RochesterMinnesota55905-
-St LouisMissouri63110-
-Las VegasNevada89135-
-PortsmouthNew Hampshire03801-
-NorthfieldNew Jersey08225-
-AlbuquerqueNew Mexico87109-
-Great NeckNew York11021-
-ShirleyNew York11967-
-CincinnatiOhio45242-
-ClevelandOhio44195-
-AshlandOregon97520-
-Camp HillPennsylvania17011-
-PhiladelphiaPennsylvania19107-
-PittsburghPennsylvania15212-
-LadsonSouth Carolina29456-
-NashvilleTennessee37232-
-AbileneTexas79606-
-AustinTexas78705-
-TylerTexas75701-
-Salt Lake CityUtah84132-
-FairfaxVirginia22031-
-MadisonWisconsin53705-

Find similar trials in Phoenix, AZ

By condition
Age-related macular degeneration
By specialty
OphthalmologyRetina

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