- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01944839
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Subjects will be randomized in a 1:1 ratio to the following dose groups:
- 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).
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Graz, Austria, 8036
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Innsbruck, Austria, 6020
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Linz, Austria, 4021
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Wien, Austria, 1090
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Antwerpen
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Deurne, Antwerpen, Belgium, 2100
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Vlaams-Brabant
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Leuven, Vlaams-Brabant, Belgium, 3000
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Minas Gerais, Brazil, 30150-270
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Sao Paulo, Brazil, 01525-001
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Sao Paulo, Brazil, 04021-050
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Sao Paulo, Brazil, 04023-062
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Goiás
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Goiânia, Goiás, Brazil, 74210
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Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brazil, 90440
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Alberta
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Calgary, Alberta, Canada, T2H 0C8
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 3N9
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Manitoba
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Winnipeg, Manitoba, Canada, R3P 1A2
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H 2Y9
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Ontario
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London, Ontario, Canada, N6A 4V2
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Mississauga, Ontario, Canada, L4W 1W9
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Ottawa, Ontario, Canada, K1H 8L6
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Toronto, Ontario, Canada, M5T 2S8
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Toronto, Ontario, Canada, M4N 3M5
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Quebec
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Montreal, Quebec, Canada, H3A 1A1
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7K 0M7
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Brno, Czechia, 625 00
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Kralovice, Czechia, 500 05
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Libeň, Czechia, 401 13
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Olomouc, Czechia, 775 20
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Prague, Czechia, 10 100 34
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Praha, Czechia, 6 169 02
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Harju, Estonia, 11412
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Tallinn, Estonia, 10138
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Tartu, Estonia, 51003
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Ancona, Italy, 60126
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Bologna, Italy, 40138
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Ferrara, Italy, 44121
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Firenze, Italy, 50134
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Milano, Italy, 20122
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Milano, Italy, 20132
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Milano, Italy, 20157
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Padova, Italy, 35128
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Roma, Italy, 00133
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Roma, Italy, 00198
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Torino, Italy, 10122
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Udine, Italy, 33100
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Riga, Latvia, LV-1050
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Riga, Latvia, LV-11002
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Bydgoszcz, Poland, 85-631
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Katowice, Poland, 43-300
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Lodz, Poland, 91 -134
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Warszawa, Poland, 02005
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Wroclaw, Poland, 50-556
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Banska Bystrica, Slovakia, 975 17
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Bratislava, Slovakia, 826 06
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Trencin, Slovakia, 91171
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Basel, Switzerland, 4102
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Bern, Switzerland, 3010
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Lausanne, Switzerland, 1000
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Zurich, Switzerland, 8063
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Belfast, United Kingdom, BT12 6BA
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Liverpool, United Kingdom, L7 8XP
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London, United Kingdom, EC1V 2PD
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London, United Kingdom, SE5 9RS
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Plymouth, United Kingdom, PL6 8DH
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Southampton, United Kingdom, SO16 6YD
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Surrey Quays, United Kingdom, GU17UJ
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Arizona
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Phoenix, Arizona, United States, 85014
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California
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Bakersfield, California, United States, 93309
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Beverly Hills, California, United States, 90211
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Los Angeles, California, United States, 90095
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San Francisco, California, United States, 94107
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Santa Barbara, California, United States, 93103
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Colorado
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Colorado Springs, Colorado, United States, 80909
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Connecticut
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Bridgeport, Connecticut, United States, 06606
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New London, Connecticut, United States, 06320
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Florida
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Altamonte Springs, Florida, United States, 32701
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Fort Myers, Florida, United States, 33907
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Sarasota, Florida, United States, 34233
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Tampa, Florida, United States, 33609
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Tampa, Florida, United States, 33612
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Winter Haven, Florida, United States, 33880
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Georgia
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Marietta, Georgia, United States, 30060
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Illinois
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Springfield, Illinois, United States, 62704-2173
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Indiana
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Indianapolis, Indiana, United States, 46290
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Kansas
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Leawood, Kansas, United States, 66211
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Kentucky
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Lexington, Kentucky, United States, 40509
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Lexington, Kentucky, United States, 40536
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Louisville, Kentucky, United States, 40202
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Louisiana
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New Orleans, Louisiana, United States, 70121
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Maryland
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Chevy Chase, Maryland, United States, 20815
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Massachusetts
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Boston, Massachusetts, United States, 02111
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Boston, Massachusetts, United States, 02114
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Michigan
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Jackson, Michigan, United States, 49202
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Southfield, Michigan, United States, 48034
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Minnesota
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Rochester, Minnesota, United States, 55905
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Missouri
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Saint Louis, Missouri, United States, 63110
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Nevada
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Las Vegas, Nevada, United States, 89135
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New Hampshire
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Portsmouth, New Hampshire, United States, 03801
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New Jersey
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Northfield, New Jersey, United States, 08225
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New Mexico
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Albuquerque, New Mexico, United States, 87109
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New York
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Great Neck, New York, United States, 11021
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Shirley, New York, United States, 11967
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Ohio
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Cincinnati, Ohio, United States, 45242
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Cleveland, Ohio, United States, 44195
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Oregon
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Ashland, Oregon, United States, 97520
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Pennsylvania
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Camp Hill, Pennsylvania, United States, 17011
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Philadelphia, Pennsylvania, United States, 19107
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Pittsburgh, Pennsylvania, United States, 15212
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South Carolina
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Ladson, South Carolina, United States, 29456
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Tennessee
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Nashville, Tennessee, United States, 37232
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Texas
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Abilene, Texas, United States, 79606
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Austin, Texas, United States, 78705
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Tyler, Texas, United States, 75701
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Utah
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Salt Lake City, Utah, United States, 84132
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Virginia
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Fairfax, Virginia, United States, 22031
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Wisconsin
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Madison, Wisconsin, United States, 53705
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Subjects of either gender aged ≥ 50 years
- Active subfoveal choroidal neovascularization (CNV) secondary to AMD
- Presence of sub-retinal hyper-reflective material (SD-OCT)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: E10030 + ranibizumab
E10030 1.5 mg intravitreal injection + ranibizumab 0.5 mg intravitreal injection
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Other Names:
Other Names:
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Active Comparator: Sham + ranibizumab
E10030 sham intravitreal injection + ranibizumab 0.5 mg intravitreal injection
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Other Names:
Pressure on the eye with a syringe with no needle
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change in Visual Acuity From Baseline to 12 Months
Time Frame: 12 Months
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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.
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12 Months
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OPH1002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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