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
627
11 countries
121
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
121 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 12, 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 15, 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 (121)
Unknown Facility
Tucson, Arizona, 85704, United States
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Tucson, Arizona, 85710, United States
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Fresno, California, 93720, United States
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La Jolla, California, 92093, United States
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Loma Linda, California, 92354, United States
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Mountain View, California, 94040, United States
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Sacramento, California, 95819, United States
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Santa Ana, California, 92705, United States
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Aurora, Colorado, 80045, United States
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Golden, Colorado, 80401, United States
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Boynton Beach, Florida, 33426, United States
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Fort Lauderdale, Florida, 33308, United States
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Fort Myers, Florida, 33912, United States
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Largo, Florida, 33770, United States
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Orlando, Florida, 32806, United States
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Atlanta, Georgia, 30322, United States
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Augusta, Georgia, 30909, United States
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Harvey, Illinois, 60426, United States
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West Des Moines, Iowa, 50266, United States
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Shawnee Mission, Kansas, 66204, United States
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Wichita, Kansas, 67214, United States
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Baltimore, Maryland, 21209, United States
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Hagerstown, Maryland, 21740, United States
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Peabody, Massachusetts, 01960, United States
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Worcester, Massachusetts, 01605, United States
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Minneapolis, Minnesota, 55435, United States
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Lawrenceville, New Jersey, 08648, United States
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New York, New York, 10022, United States
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Syracuse, New York, 13224, United States
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Asheville, North Carolina, 28803, United States
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Charlotte, North Carolina, 28210, United States
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Winston-Salem, North Carolina, 27157, United States
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Cleveland, Ohio, 44122, United States
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Cleveland, Ohio, 44130, United States
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Oklahoma City, Oklahoma, 73104, United States
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Greenville, South Carolina, 29605, United States
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West Columbia, South Carolina, 29169, United States
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Rapid City, South Dakota, 57701, United States
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Nashville, Tennessee, 37203, United States
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Austin, Texas, 78705, United States
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Dallas, Texas, 75231, United States
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Houston, Texas, 77030, United States
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McAllen, Texas, 78503, United States
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San Antonio, Texas, 78233, United States
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San Antonio, Texas, 78240, United States
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Salt Lake City, Utah, 84107, United States
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Richmond, Virginia, 23226, United States
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Virginia Beach, Virginia, 23454, United States
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Bellevue, Washington, 98004, United States
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Buenos Aires, B1629ODT, Argentina
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Buenos Aires, C1015ABO, Argentina
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Buenos Aires, C1120AAN, Argentina
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Buenos Aires, C1122AAI, Argentina
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Córdoba, 5000, Argentina
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Santa Fe, 2000, Argentina
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East Melbourne, 3002, Australia
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Malvern, 3144, Australia
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Nedlands, 6009, Australia
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Parramatta, 2150, Australia
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Sydney, 2000, Australia
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Westmead, 2145, Australia
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Bogotá, 110311, Colombia
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Cali, 76001000, Colombia
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Medellín, Colombia
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Aalborg, 9000, Denmark
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Aarhus C, 8000, Denmark
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Glostrup Municipality, 2600, Denmark
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Odense, 5000, Denmark
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Roskilde, 4000, Denmark
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Créteil, 94010, France
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Lyon, 69003, France
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Lyon, 69317, France
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Marseille, 13008, France
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Paris, 75006, France
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Paris, 75015, France
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Paris, 75019, France
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Paris, 75745, France
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Rouen, 76100, France
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Strasbourg, 67091, France
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Tours, 37000, France
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Aachen, 52057, Germany
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Bonn, 53127, Germany
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Cologne, 50924, Germany
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Freiburg im Breisgau, 79106, Germany
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Göttingen, 37075, Germany
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Hamburg, 20246, Germany
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Heidelberg, 69120, Germany
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Karlsruhe, 76131, Germany
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Kiel, 24105, Germany
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Leipzig, D-04103, Germany
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Lübeck, 23538, Germany
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Mainz, 55131, Germany
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München, 80336, Germany
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München, 81675, Germany
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Münster, 48145, Germany
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Münster, 48165, Germany
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Tübingen, 72076, Germany
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Budapest, 1076, Hungary
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Budapest, 1106, Hungary
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Budapest, 1133, Hungary
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Budapest, H-1083, Hungary
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Budapest, H-1145, Hungary
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Debrecen, H-4012, Hungary
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Magyarszék, 8200, Hungary
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Pécs, 7621, Hungary
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Szeged, 6720, Hungary
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Haifa, 31096, Israel
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Jerusalem, 91120, Israel
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Kfar Saba, 4428164, Israel
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Petah Tikva, 49100, Israel
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Rehovot, 76100, Israel
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Tel Aviv, 64239, Israel
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Barcelona, 08022, Spain
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Bilbao, 48006, Spain
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Las Palmas, 35016, Spain
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Navarro, 31008, Spain
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Sant Cugat del Vallès, 08195, Spain
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Valencia, 46015, Spain
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Ankara, 6100, Turkey (Türkiye)
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Izmir, 35100, Turkey (Türkiye)
Unknown Facility
Izmir, 35340, Turkey (Türkiye)
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 Corp.
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 12, 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 15, 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/.