A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Lucentis® Monotherapy

Last updated: October 19, 2024
Sponsor: Ophthotech Corporation
Overall Status: Terminated

Phase

3

Condition

Aging

Macular Degeneration

Myopic Macular Degeneration

Treatment

E10030 sham intravitreal injection

ranibizumab

E10030

Clinical Study ID

NCT01944839
OPH1002
  • Ages > 50
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Any prior treatment for AMD in the study eye prior to the Day 1 visit, except oralsupplements 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. Anyprior thermal laser in the macular region, regardless of indication

  • Subjects with subfoveal scar or subfoveal atrophy are excluded

  • Diabetes mellitus

Study Design

Total Participants: 619
Treatment Group(s): 3
Primary Treatment: E10030 sham intravitreal injection
Phase: 3
Study Start date:
August 01, 2013
Estimated Completion Date:
December 31, 2016

Study 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).

Connect with a study center

  • Graz, 8036
    Austria

    Site Not Available

  • Innsbruck, 6020
    Austria

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    Kralove, 500 05
    Austria

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  • Linz, 4021
    Austria

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  • Wien, 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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  • Sao 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 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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    Labem, 401 13
    Czech Republic

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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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  • Praha, 6 169 02
    Czechia

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  • Harju, 11412
    Estonia

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    Harjumaa, 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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  • Firenze, 50134
    Italy

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  • Milano, 20122
    Italy

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  • Padova, 35128
    Italy

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  • Roma, 00133
    Italy

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  • Torino, 10122
    Italy

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    Torrette di Ancona, 60126
    Italy

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  • Udine, 33100
    Italy

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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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  • Warszawa, 02005
    Poland

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  • Wroclaw, 50-556
    Poland

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  • Banska Bystrica, 975 17
    Slovakia

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  • Bratislava, 826 06
    Slovakia

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  • Trencin, 91171
    Slovakia

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  • Basel, 4102
    Switzerland

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    Basel-Landschaft, 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, 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, GU17UJ
    United Kingdom

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  • Surrey Quays, GU17UJ
    United Kingdom

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  • 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 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 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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  • Jackson, Michigan 49202
    United States

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    Royal Oak, Michigan 48073
    United States

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  • Southfield, Michigan 48034
    United States

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  • Rochester, Minnesota 55905
    United States

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  • Saint Louis, Missouri 63110
    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
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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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