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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

Information source: Ophthotech Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Age-Related Macular Degeneration

Intervention: E10030 (Drug); bevacizumab or aflibercept (Drug); E10030 sham intravitreal injection (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Ophthotech Corporation

Overall contact:
Walesca Ayala, Phone: 212-845-8227, Email: walesca.ayala@ophthotech.com

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).

Clinical Details

Official title: 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.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Mean change in visual acuity from baseline at the Month 12 visit.

Detailed description: Subjects will be randomized in a 1: 1 ratio to the following dose groups:

- Fovista® 1. 5 mg/eye + Avastin® 1. 25 mg/eye or Eylea® 2 mg/eye

- Fovista® sham + Avastin® 1. 25 mg/eye or Eylea® 2 mg/eye

Subjects will be treated for up to 24 months with active Fovista® or sham in combination with either Avastin® or Eylea® 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).

Eligibility

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Walesca Ayala, Phone: 212-845-8227, Email: walesca.ayala@ophthotech.com

Osijek 31000, Croatia; Recruiting

Rijeka 51000, Croatia; Recruiting

Zagreb 1000, Croatia; Recruiting

Helsinki 00200, Finland; Recruiting

Kuopio 70210, Finland; Recruiting

Creteil 94010, France; Recruiting

Lyon 69003, France; Recruiting

Lyon 69317, France; Recruiting

Marseille 13008, France; Recruiting

Paris 75006, France; Recruiting

Paris 75019, France; Recruiting

Paris 75015, France; Recruiting

Rouen 76100, France; Recruiting

Strasbourg 67091, France; Recruiting

Tours 37000, France; Recruiting

Lübeck 23538, Germany; Recruiting

Niedersachsen 37075, Germany; Recruiting

Tübingen 72076, Germany; Recruiting

Budapest 1083, Hungary; Recruiting

Budapest 1106, Hungary; Recruiting

Budapest 1133, Hungary; Recruiting

Pecs 7621, Hungary; Recruiting

Veszprem 8200, Hungary; Recruiting

Haifa 3109601, Israel; Recruiting

Jerusalem 91120, Israel; Recruiting

Kfar Saba 4428164, Israel; Recruiting

Pita Tikva 4941492, Israel; Recruiting

Rehovot 76100, Israel; Recruiting

Tel Aviv 64239, Israel; Recruiting

Stavanger 4016, Norway; Recruiting

Coimbra 3000-548, Portugal; Recruiting

Coimbra 3030-163, Portugal; Recruiting

Lisboa 1169-050, Portugal; Recruiting

Lisboa 1050-085, Portugal; Recruiting

Porto 4200-319, Portugal; Recruiting

Vila Franca de Xira 2600-009, Portugal; Recruiting

A Coruña 15706, Spain; Recruiting

Albacete 02008, Spain; Recruiting

Asturias 33012, Spain; Recruiting

Barcelona 08021, Spain; Recruiting

Barcelona 08022, Spain; Recruiting

Barcelona 08035, Spain; Recruiting

Barcelona 08195, Spain; Recruiting

Valencia 46015, Spain; Recruiting

Gilbert, Arizona 85295, United States; Recruiting

Tucson, Arizona 85704, United States; Recruiting

Tucson, Arizona 85710, United States; Recruiting

Campbell, California 95008, United States; Recruiting

Fresno, California 93720, United States; Recruiting

Fullerton, California 92835, United States; Recruiting

Irvine, California 92697, United States; Recruiting

La Jolla, California 92037, United States; Recruiting

Mountain View, California 94040, United States; Recruiting

Palm Desert, California 92211, United States; Recruiting

Redlands, California 92374, United States; Recruiting

Sacramento, California 95819, United States; Recruiting

Sacramento, California 95841, United States; Recruiting

San Francisco, California 94143, United States; Recruiting

Santa Ana, California 92705, United States; Recruiting

Ventura, California 93003, United States; Recruiting

Aurora, Colorado 80045, United States; Recruiting

Colorado Springs, Colorado 80909, United States; Recruiting

Denver, Colorado 80210, United States; Recruiting

Golden, Colorado 80401, United States; Recruiting

Hamden, Connecticut 06518, United States; Recruiting

Boynton Beach, Florida 33426, United States; Recruiting

Fort Lauderdale, Florida 33308, United States; Recruiting

Fort Myers, Florida 33912, United States; Recruiting

Largo, Florida 33770, United States; Recruiting

Melbourne, Florida 32901, United States; Recruiting

Pensacola, Florida 32503, United States; Recruiting

St. Petersburg, Florida 33711, United States; Recruiting

Tallahassee, Florida 32308, United States; Recruiting

Augusta, Georgia 30909, United States; Recruiting

Oak Forest, Illinois 60452, United States; Recruiting

Peoria, Illinois 61615, United States; Recruiting

West Des Moines, Iowa 50266, United States; Recruiting

Palmas de Gran Canaria, Islas Canarias 35016, Spain; Recruiting

Topeka, Kansas 66615, United States; Recruiting

Wichita, Kansas 67214, United States; Recruiting

Paducah,, Kentucky 42001, United States; Recruiting

Baltimore, Maryland 21209, United States; Recruiting

Hagerstown, Maryland 21740, United States; Recruiting

Towson, Maryland 21204, United States; Recruiting

Worcestor, Massachusetts 01605, United States; Recruiting

Minneapolis, Minnesota 55435, United States; Recruiting

Chesterfield, Missouri 63017, United States; Recruiting

St. Louis, Missouri 63110, United States; Recruiting

Pamplona, Navarra 31008, Spain; Recruiting

Omaha, Nebraska 68105, United States; Recruiting

Las Vegas, Nevada 89144, United States; Recruiting

Reno, Nevada 89502, United States; Recruiting

Lawrenceville, New Jersey 08648, United States; Recruiting

Albury, New South Wales 2640, Australia; Recruiting

Parramatta, New South Wales 2150, Australia; Recruiting

Sydney, New South Wales 2000, Australia; Recruiting

West Mead, New South Wales 2145, Australia; Recruiting

New York, New York 10021, United States; Recruiting

Rochester, New York 14620, United States; Recruiting

Syracuse, New York 13224, United States; Recruiting

Munster, Norhdhein-Westfalen 48145, Germany; Recruiting

Ashville, North Carolina 28803, United States; Recruiting

Winston-Salem, North Carolina 27157, United States; Recruiting

Cleveland, Ohio 44122, United States; Recruiting

Cleveland, Ohio 44130, United States; Recruiting

Columbus, Ohio 43212, United States; Recruiting

Oklahoma City, Oklahoma 73104, United States; Recruiting

Portland, Oregon 97239, United States; Recruiting

Portland, Oregon 97210, United States; Recruiting

Philadelphia, Pennsylvania 19104, United States; Recruiting

West Mifflin, Pennsylvania 15122, United States; Recruiting

Leipzig, Sachsen 04103, Germany; Recruiting

West Columbia, South Carolina 29169, United States; Recruiting

Rapid City, South Dakota 57701, United States; Recruiting

Amarillo, Texas 79106, United States; Recruiting

Dallas, Texas 75231, United States; Recruiting

Fort Worth, Texas 43212, United States; Recruiting

McAllen, Texas 78503, United States; Recruiting

Plano, Texas 75093, United States; Recruiting

San Antonio, Texas 78233, United States; Recruiting

San Antonio, Texas 78240, United States; Recruiting

Shawnee Mission, Texas 66204, United States; Recruiting

Willow Park, Texas 76087, United States; Recruiting

Salt Lake City, Utah 84107, United States; Recruiting

East Melbourne, Victoria 3002, Australia; Recruiting

Richmond, Virginia 23235, United States; Recruiting

Virginia Beach, Virginia 23462, United States; Recruiting

Bilbao, Vizcaya 48006, Spain; Recruiting

Bellevue, Washington 98004, United States; Recruiting

Silverdale, Washington 98383, United States; Recruiting

Morgantown, West Virginia 25606, United States; Recruiting

Additional Information

Starting date: May 2014
Last updated: August 10, 2015

Page last updated: August 23, 2015

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