A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Either Avastin® or Eylea® Compared to Avastin® or Eylea® 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 Either Avastin® or Eylea® Compared to Avastin® or Eylea® Monotherapy in Subjects With Subfoveal Neovascular Age-related Macular Degeneration.
1 other identifier
interventional
645
20 countries
204
Brief Summary
The objectives of this study are to evaluate the safety and efficacy of intravitreal administration of Fovista® administered in combination with either Avastin® or Eylea® compared to Avastin® or Eylea® 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 May 2014
Typical duration for phase_3
204 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
First Submitted
Initial submission to the registry
September 9, 2013
CompletedFirst Posted
Study publicly available on registry
September 12, 2013
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedResults Posted
Study results publicly available
September 30, 2020
CompletedOctober 31, 2024
September 1, 2020
3.1 years
September 9, 2013
June 18, 2019
October 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change in Visual Acuity (Measured at Baseline and at the Month 12 Visit)
The primary efficacy endpoint is the mean change in visual acuity (ETDRS letters) measured at baseline and at 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 + bevacizumab or aflibercept
EXPERIMENTALE10030 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection
Sham + bevacizumab or aflibercept
ACTIVE COMPARATORE10030 sham injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection
Interventions
Patients are randomized to receive either bevacizumab or aflibercept
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 (207)
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Gilbert, Arizona, 85295, United States
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Phoenix, Arizona, 85014, United States
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Tucson, Arizona, 85704, United States
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Tucson, Arizona, 85710, United States
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Campbell, California, 95008, United States
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Fresno, California, 93720, United States
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Fullerton, California, 92835, United States
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Irvine, California, 92697, United States
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La Jolla, California, 92037, United States
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Mountain View, California, 94040, United States
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Palm Desert, California, 92211, United States
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Redlands, California, 92374, United States
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Sacramento, California, 95819, United States
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Sacramento, California, 95841, United States
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San Francisco, California, 94109, United States
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Santa Ana, California, 92705, United States
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Ventura, California, 93003, United States
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Aurora, Colorado, 80045, United States
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Colorado Springs, Colorado, 80909, United States
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Denver, Colorado, 80210, United States
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Golden, Colorado, 80401, United States
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Hamden, Connecticut, 06518, 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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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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Melbourne, Florida, 32901, United States
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Palm Beach Gardens, Florida, 33410, United States
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Pensacola, Florida, 32503, United States
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St. Petersburg, Florida, 33711, United States
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Tallahassee, Florida, 32308, United States
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Tampa, Florida, 33609, United States
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Winter Haven, Florida, 33880, United States
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Atlanta, Georgia, 30322, United States
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Augusta, Georgia, 30909, United States
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Marietta, Georgia, 30060, United States
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Oak Forest, Illinois, 60452, United States
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Peoria, Illinois, 61615, United States
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West Des Moines, Iowa, 50266, United States
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Leawood, Kansas, 66211, United States
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Shawnee Mission, Kansas, 66204, United States
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Topeka, Kansas, 66615, United States
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Wichita, Kansas, 67214, United States
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Paducah, Kentucky, 42001, United States
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Baltimore, Maryland, 21209, United States
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Chevy Chase, Maryland, 20815, United States
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Hagerstown, Maryland, 21740, United States
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Towson, Maryland, 21204, United States
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Boston, Massachusetts, 02111, United States
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Boston, Massachusetts, 02114, United States
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Peabody, Massachusetts, 01960, United States
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Worcester, Massachusetts, 01605, United States
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Jackson, Michigan, 49202, United States
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Lansing, Michigan, 48912, United States
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Southfield, Michigan, 48034, United States
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Minneapolis, Minnesota, 55435, United States
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Chesterfield, Missouri, 63017, United States
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St Louis, Missouri, 63110, United States
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St Louis, Missouri, 63128, United States
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Omaha, Nebraska, 68105, United States
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Las Vegas, Nevada, 89144, United States
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Reno, Nevada, 89502, United States
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Lawrenceville, New Jersey, 08648, United States
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Albuquerque, New Mexico, 87109, United States
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New York, New York, 10021, United States
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Rochester, New York, 14620, 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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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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Columbus, Ohio, 43212, United States
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Oklahoma City, Oklahoma, 73104, United States
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Portland, Oregon, 97210, United States
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Portland, Oregon, 97239, United States
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Camp Hill, Pennsylvania, 17011, United States
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Philadelphia, Pennsylvania, 19104, United States
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Philadelphia, Pennsylvania, 19107, United States
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West Mifflin, Pennsylvania, 15122, United States
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Ladson, South Carolina, 29456, 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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Abilene, Texas, 79606, United States
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Amarillo, Texas, 79106, United States
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Dallas, Texas, 75231, United States
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Fort Worth, Texas, 43212, United States
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McAllen, Texas, 78503, United States
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Plano, Texas, 75093, 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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Willow Park, Texas, 76087, United States
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Salt Lake City, Utah, 84107, United States
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Salt Lake City, Utah, 84132, United States
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Richmond, Virginia, 23235, United States
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Virginia Beach, Virginia, 23462, United States
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Bellevue, Washington, 98004, United States
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Silverdale, Washington, 98383, United States
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Morgantown, West Virginia, 25606, United States
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Buenos Aires, B1629ODT, Argentina
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Buenos Aires, C1015ABO, Argentina
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Buenos Aires, C1112AAI, Argentina
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Buenos Aires, C1120AAN, Argentina
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Córdoba, 5000, Argentina
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Santa Fe, 2000, Argentina
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Albury, New South Wales, 2640, Australia
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Parramatta, New South Wales, 2150, Australia
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Sydney, New South Wales, 2000, Australia
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Westmead, New South Wales, 2145, Australia
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East Melbourne, Victoria, 3002, Australia
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Graz, 8036, Austria
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Goiânia, 74210, Brazil
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São Paulo, 01525-001, Brazil
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São Paulo, 04023-062, Brazil
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Vancouver, British Columbia, V5Z 1E9, Canada
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Vancouver, British Columbia, V5Z 3N9, Canada
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Winnipeg, Manitoba, R3C 1A2, Canada
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Mississauga, Ontario, L4W 1W9, Canada
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Montral, Quebec, H1T 2M4, Canada
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Bogotá, 110231, Colombia
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Medellín, 050016, Colombia
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Osijek, 31000, Croatia
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Rijeka, 51000, Croatia
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Zagreb, 1000, Croatia
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Brno, 625 00, Czechia
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Hradec Králové, 500 05, Czechia
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Olomouc, 779 00, Czechia
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Prague, 10 100 34, Czechia
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Prague, 169 02, Czechia
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Tallinn, 10138, Estonia
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Tallinn, 11412, Estonia
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Helsinki, 00200, Finland
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Kuopio, 70210, Finland
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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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Münster, Norhdhein-Westfalen, 48145, Germany
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Aachen, North Rhine-Westphalia, 52074, Germany
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Leipzig, Saxony, 04103, Germany
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Kiel, Schleswig-Holstein, 24105, Germany
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Göttingen, 37075, Germany
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Hamburg, 20246, Germany
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Karlsruhe, 76133, Germany
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Lübeck, 23538, Germany
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Mainz, 55131, Germany
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Tübingen, 72076, Germany
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Budapest, 1076, Hungary
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Budapest, 1083, Hungary
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Budapest, 1106, Hungary
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Budapest, 1133, Hungary
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Budapest, 1145, Hungary
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Debrecen, 4012, Hungary
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Pécs, 7621, Hungary
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Szeged, 6720, Hungary
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Veszprém, 8200, Hungary
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Haifa, 3109601, Israel
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Jerusalem, 91120, Israel
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Kfar Saba, 4428164, Israel
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Pita Tikva, 4941492, Israel
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Rehovot, 76100, Israel
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Tel Aviv, 64239, Israel
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Ancona, 60126, Italy
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Bologna, 40138, Italy
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Ferrara, 44124, 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-1002, Latvia
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Riga, LV-1050, Latvia
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Stavanger, 4016, Norway
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Bydgoszcz, 85-631, Poland
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Katowice, 40-594, Poland
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Lodz, 91-134, Poland
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Wroclaw, 50-556, Poland
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Coimbra, 3000-548, Portugal
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Coimbra, 3030-163, Portugal
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Lisbon, 1050-085, Portugal
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Lisbon, 1169-050, Portugal
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Porto, 4200-319, Portugal
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Vila Franca de Xira, 2600-009, Portugal
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Banská Bystrica, 975 17, Slovakia
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Trenčín, 91171, Slovakia
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Las Palmas de Gran Canaria, Canary Islands, 35016, Spain
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Pamplona, Navarre, 31008, Spain
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Bilbao, Vizcaya, 48006, Spain
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A Coruña, 15706, Spain
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Albacete, 02008, Spain
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Barcelona, 08021, Spain
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Barcelona, 08022, Spain
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Barcelona, 08035, Spain
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Barcelona, 08195, Spain
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Oviedo, 33012, Spain
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Valencia, 46015, Spain
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
- Keith Westby
- 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
May 1, 2014
Primary Completion
June 1, 2017
Study Completion
September 1, 2017
Last Updated
October 31, 2024
Results First Posted
September 30, 2020
Record last verified: 2020-09
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/.