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 Tucson, Arizona.

Sponsor
Ophthotech Corporation
Study ID
NCT01940900
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 12, 2013
Start date
Aug 31, 2013
Status verified
Aug 2018
Primary completion
Dec 31, 2016
Completion
Dec 31, 2016

Study Design

Enrollment
627 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 (49)

FacilityCityStateZIPSite coordinators
-TucsonArizona85704-
-TucsonArizona85710-
-FresnoCalifornia93720-
-La JollaCalifornia92093-
-Loma LindaCalifornia92354-
-Mountain ViewCalifornia94040-
-SacramentoCalifornia95819-
-Santa AnaCalifornia92705-
-AuroraColorado80045-
-GoldenColorado80401-
-Boynton BeachFlorida33426-
-Fort LauderdaleFlorida33308-
-Fort MyersFlorida33912-
-LargoFlorida33770-
-OrlandoFlorida32806-
-AtlantaGeorgia30322-
-AugustaGeorgia30909-
-HarveyIllinois60426-
-West Des MoinesIowa50266-
-Shawnee MissionKansas66204-
-WichitaKansas67214-
-BaltimoreMaryland21209-
-HagerstownMaryland21740-
-PeabodyMassachusetts01960-
-WorcesterMassachusetts01605-
-MinneapolisMinnesota55435-
-LawrencevilleNew Jersey08648-
-New YorkNew York10022-
-SyracuseNew York13224-
-AshevilleNorth Carolina28803-
-CharlotteNorth Carolina28210-
-Winston-SalemNorth Carolina27157-
-ClevelandOhio44122-
-ClevelandOhio44130-
-Oklahoma CityOklahoma73104-
-GreenvilleSouth Carolina29605-
-West ColumbiaSouth Carolina29169-
-Rapid CitySouth Dakota57701-
-NashvilleTennessee37203-
-AustinTexas78705-
-DallasTexas75231-
-HoustonTexas77030-
-McAllenTexas78503-
-San AntonioTexas78233-
-San AntonioTexas78240-
-Salt Lake CityUtah84107-
-RichmondVirginia23226-
-Virginia BeachVirginia23454-
-BellevueWashington98004-

Find similar trials in Tucson, AZ

By condition
Age-related macular degeneration
By specialty
OphthalmologyRetina

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