A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Lucentis® Monotherapy
NCT ID: NCT01944839
Last Updated: 2024-10-30
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
619 participants
INTERVENTIONAL
2013-08-31
2016-12-31
Brief Summary
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Detailed Description
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* Fovista® 1.5 mg/eye + Lucentis® 0.5 mg/eye
* Fovista® sham + Lucentis® 0.5 mg/eye
Subjects will be treated for a total of 24 months with active Fovista® or sham in combination with Lucentis® with the primary endpoint at 12 months.
Primary Efficacy Endpoint:
The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) from baseline at the month 12 visit.
Safety Endpoints:
Safety endpoints include adverse events, vital signs, ophthalmic variables \[ophthalmic examination, intraocular pressure (IOP), fluorescein angiogram (FA), optical coherence tomography (OCT)\], ECG, and laboratory variables.
Approximately 622 subjects will be randomized into one of the two treatment cohorts (311 patients per dose group).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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E10030 + ranibizumab
E10030 1.5 mg intravitreal injection + ranibizumab 0.5 mg intravitreal injection
E10030
ranibizumab
Sham + ranibizumab
E10030 sham intravitreal injection + ranibizumab 0.5 mg intravitreal injection
ranibizumab
E10030 sham intravitreal injection
Pressure on the eye with a syringe with no needle
Interventions
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E10030
ranibizumab
E10030 sham intravitreal injection
Pressure on the eye with a syringe with no needle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Active subfoveal choroidal neovascularization (CNV) secondary to AMD
* Presence of sub-retinal hyper-reflective material (SD-OCT)
Exclusion Criteria
* Any prior intravitreal treatment in the study eye prior to the Day 1 visit, regardless of indication (including intravitreal corticosteroids)
* Any intraocular surgery or thermal laser within three (3) months of trial entry. Any prior thermal laser in the macular region, regardless of indication
* Subjects with subfoveal scar or subfoveal atrophy are excluded
* Diabetes mellitus
50 Years
ALL
No
Sponsors
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Ophthotech Corporation
INDUSTRY
Responsible Party
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Locations
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Phoenix, Arizona, United States
Bakersfield, California, United States
Beverly Hills, California, United States
Los Angeles, California, United States
San Francisco, California, United States
Santa Barbara, California, United States
Colorado Springs, Colorado, United States
Bridgeport, Connecticut, United States
New London, Connecticut, United States
Altamonte Springs, Florida, United States
Fort Myers, Florida, United States
Sarasota, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Winter Haven, Florida, United States
Marietta, Georgia, United States
Springfield, Illinois, United States
Indianapolis, Indiana, United States
Leawood, Kansas, United States
Lexington, Kentucky, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
New Orleans, Louisiana, United States
Chevy Chase, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Jackson, Michigan, United States
Southfield, Michigan, United States
Rochester, Minnesota, United States
St Louis, Missouri, United States
Las Vegas, Nevada, United States
Portsmouth, New Hampshire, United States
Northfield, New Jersey, United States
Albuquerque, New Mexico, United States
Great Neck, New York, United States
Shirley, New York, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Ashland, Oregon, United States
Camp Hill, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Ladson, South Carolina, United States
Nashville, Tennessee, United States
Abilene, Texas, United States
Austin, Texas, United States
Tyler, Texas, United States
Salt Lake City, Utah, United States
Fairfax, Virginia, United States
Madison, Wisconsin, United States
Graz, , Austria
Innsbruck, , Austria
Linz, , Austria
Vienna, , Austria
Deurne, Antwerpen, Belgium
Leuven, Vlaams-Brabant, Belgium
Goiânia, Goiás, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Minas Gerais, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
Calgary, Alberta, Canada
Vancouver, British Columbia, Canada
Winnipeg, Manitoba, Canada
Halifax, Nova Scotia, Canada
London, Ontario, Canada
Mississauga, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Brno, , Czechia
Kralovice, , Czechia
Libeň, , Czechia
Olomouc, , Czechia
Prague, , Czechia
Prague, , Czechia
Harju, , Estonia
Tallinn, , Estonia
Tartu, , Estonia
Ancona, , Italy
Bologna, , Italy
Ferrara, , Italy
Florence, , Italy
Milan, , Italy
Milan, , Italy
Milan, , Italy
Padua, , Italy
Roma, , Italy
Roma, , Italy
Torino, , Italy
Udine, , Italy
Riga, , Latvia
Riga, , Latvia
Bydgoszcz, , Poland
Katowice, , Poland
Lodz, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Banská Bystrica, , Slovakia
Bratislava, , Slovakia
Trenčín, , Slovakia
Basel, , Switzerland
Bern, , Switzerland
Lausanne, , Switzerland
Zurich, , Switzerland
Belfast, , United Kingdom
Liverpool, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Plymouth, , United Kingdom
Southampton, , United Kingdom
Surrey Quays, , United Kingdom
Countries
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References
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Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.
Other Identifiers
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OPH1002
Identifier Type: -
Identifier Source: org_study_id
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