A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Lucentis® Monotherapy
A Phase 3 Randomized, Double-masked, Controlled Trial to Establish the Safety and Efficacy of Intravitreous Administration of Fovista® (Anti PDGF-B Pegylated Aptamer) Administered in Combination With Lucentis® Compared to Lucentis® Monotherapy in Subjects With Subfoveal Neovascular Age-related Macular Degeneration.
1 other identifier
interventional
619
13 countries
115
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2013
Typical duration for phase_3
115 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 9, 2013
CompletedFirst Posted
Study publicly available on registry
September 18, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedResults Posted
Study results publicly available
August 10, 2018
CompletedOctober 30, 2024
August 1, 2018
3.3 years
September 9, 2013
July 11, 2018
October 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change in Visual Acuity From Baseline to 12 Months
The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) from baseline to the month 12 visit. Higher ETDRS letters represents higher vision and a higher change in ETDRS letters represents better functioning.
12 Months
Study Arms (2)
E10030 + ranibizumab
EXPERIMENTALE10030 1.5 mg intravitreal injection + ranibizumab 0.5 mg intravitreal injection
Sham + ranibizumab
ACTIVE COMPARATORE10030 sham intravitreal injection + ranibizumab 0.5 mg intravitreal injection
Interventions
Pressure on the eye with a syringe with no needle
Eligibility Criteria
You may qualify if:
- Subjects of either gender aged ≥ 50 years
- Active subfoveal choroidal neovascularization (CNV) secondary to AMD
- Presence of sub-retinal hyper-reflective material (SD-OCT)
You may not qualify if:
- Any prior treatment for AMD in the study eye prior to the Day 1 visit, except oral supplements of vitamins and minerals
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (115)
Unknown Facility
Phoenix, Arizona, 85014, United States
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Bakersfield, California, 93309, United States
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Beverly Hills, California, 90211, United States
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Los Angeles, California, 90095, United States
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San Francisco, California, 94107, United States
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Santa Barbara, California, 93103, United States
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Colorado Springs, Colorado, 80909, United States
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Bridgeport, Connecticut, 06606, United States
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New London, Connecticut, 06320, United States
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Altamonte Springs, Florida, 32701, United States
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Fort Myers, Florida, 33907, United States
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Sarasota, Florida, 34233, United States
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Tampa, Florida, 33609, United States
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Tampa, Florida, 33612, United States
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Winter Haven, Florida, 33880, United States
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Marietta, Georgia, 30060, United States
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Springfield, Illinois, 62704-2173, United States
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Indianapolis, Indiana, 46290, United States
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Leawood, Kansas, 66211, United States
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Lexington, Kentucky, 40509, United States
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Lexington, Kentucky, 40536, United States
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Louisville, Kentucky, 40202, United States
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New Orleans, Louisiana, 70121, United States
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Chevy Chase, Maryland, 20815, United States
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Boston, Massachusetts, 02111, United States
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Boston, Massachusetts, 02114, United States
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Jackson, Michigan, 49202, United States
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Southfield, Michigan, 48034, United States
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Rochester, Minnesota, 55905, United States
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St Louis, Missouri, 63110, United States
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Las Vegas, Nevada, 89135, United States
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Portsmouth, New Hampshire, 03801, United States
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Northfield, New Jersey, 08225, United States
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Albuquerque, New Mexico, 87109, United States
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Great Neck, New York, 11021, United States
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Shirley, New York, 11967, United States
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Cincinnati, Ohio, 45242, United States
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Cleveland, Ohio, 44195, United States
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Ashland, Oregon, 97520, United States
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Camp Hill, Pennsylvania, 17011, United States
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Philadelphia, Pennsylvania, 19107, United States
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Pittsburgh, Pennsylvania, 15212, United States
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Ladson, South Carolina, 29456, United States
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Nashville, Tennessee, 37232, United States
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Abilene, Texas, 79606, United States
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Austin, Texas, 78705, United States
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Tyler, Texas, 75701, United States
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Salt Lake City, Utah, 84132, United States
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Fairfax, Virginia, 22031, United States
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Madison, Wisconsin, 53705, United States
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Graz, 8036, Austria
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Innsbruck, 6020, Austria
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Linz, 4021, Austria
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Vienna, 1090, Austria
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Deurne, Antwerpen, 2100, Belgium
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Leuven, Vlaams-Brabant, 3000, Belgium
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Goiânia, Goiás, 74210, Brazil
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Porto Alegre, Rio Grande do Sul, 90440, Brazil
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Minas Gerais, 30150-270, Brazil
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São Paulo, 01525-001, Brazil
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São Paulo, 04021-050, Brazil
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São Paulo, 04023-062, Brazil
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Calgary, Alberta, T2H 0C8, Canada
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Vancouver, British Columbia, V5Z 3N9, Canada
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Winnipeg, Manitoba, R3P 1A2, Canada
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Halifax, Nova Scotia, B3H 2Y9, Canada
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London, Ontario, N6A 4V2, Canada
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Mississauga, Ontario, L4W 1W9, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5T 2S8, Canada
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Montreal, Quebec, H3A 1A1, Canada
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Saskatoon, Saskatchewan, S7K 0M7, Canada
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Brno, 625 00, Czechia
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Kralovice, 500 05, Czechia
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Libeň, 401 13, Czechia
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Olomouc, 775 20, Czechia
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Prague, 10 100 34, Czechia
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Prague, 6 169 02, Czechia
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Harju, 11412, Estonia
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Tallinn, 10138, Estonia
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Tartu, 51003, Estonia
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Ancona, 60126, Italy
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Bologna, 40138, Italy
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Ferrara, 44121, Italy
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Florence, 50134, Italy
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Milan, 20122, Italy
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Milan, 20132, Italy
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Milan, 20157, Italy
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Padua, 35128, Italy
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Roma, 00133, Italy
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Roma, 00198, Italy
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Torino, 10122, Italy
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Udine, 33100, Italy
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Riga, LV-1050, Latvia
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Riga, LV-11002, Latvia
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Bydgoszcz, 85-631, Poland
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Katowice, 43-300, Poland
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Lodz, 91 -134, Poland
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Warsaw, 02005, Poland
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Wroclaw, 50-556, Poland
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Banská Bystrica, 975 17, Slovakia
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Bratislava, 826 06, Slovakia
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Trenčín, 91171, Slovakia
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Basel, 4102, Switzerland
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Bern, 3010, Switzerland
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Lausanne, 1000, Switzerland
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Zurich, 8063, Switzerland
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Belfast, BT12 6BA, United Kingdom
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Liverpool, L7 8XP, United Kingdom
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London, EC1V 2PD, United Kingdom
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London, SE5 9RS, United Kingdom
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Plymouth, PL6 8DH, United Kingdom
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Southampton, SO16 6YD, United Kingdom
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Surrey Quays, GU17UJ, United Kingdom
Related Publications (1)
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.
PMID: 30957581DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Denise Teuber
- Organization
- Ophthotech
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2013
First Posted
September 18, 2013
Study Start
August 1, 2013
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
October 30, 2024
Results First Posted
August 10, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.