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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

Primary Purpose

Age-Related Macular Degeneration

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
E10030
bevacizumab or aflibercept
E10030 sham injection
Sponsored by
Ophthotech Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-Related Macular Degeneration focused on measuring Wet AMD, choroidal neovascularization, Fovista®, E10030, Avastin®, Eylea®

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

E10030 + bevacizumab or aflibercept

Sham + bevacizumab or aflibercept

Arm Description

E10030 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection

E10030 sham injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 9, 2013
Last Updated
September 29, 2020
Sponsor
Ophthotech Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01940887
Brief Title
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
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 Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Study Start Date
May 2014 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ophthotech Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
Detailed Description
Subjects will be randomized in a 1:1 ratio to the following two arms per study design: 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. Approximately 622 subjects will be randomized into one of the two treatment groups (311 patients per dose group), and the efficacy analysis will be based on the data from these two groups as per the SAP

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration
Keywords
Wet AMD, choroidal neovascularization, Fovista®, E10030, Avastin®, Eylea®

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
645 (Actual)

8. Arms, Groups, and Interventions

Arm Title
E10030 + bevacizumab or aflibercept
Arm Type
Experimental
Arm Description
E10030 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection
Arm Title
Sham + bevacizumab or aflibercept
Arm Type
Active Comparator
Arm Description
E10030 sham injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection
Intervention Type
Drug
Intervention Name(s)
E10030
Other Intervention Name(s)
Fovista®
Intervention Type
Drug
Intervention Name(s)
bevacizumab or aflibercept
Other Intervention Name(s)
Avastin®, Eylea®
Intervention Description
Patients are randomized to receive either bevacizumab or aflibercept
Intervention Type
Drug
Intervention Name(s)
E10030 sham injection
Other Intervention Name(s)
Sham
Intervention Description
Pressure on the eye with a syringe with no needle
Primary Outcome Measure Information:
Title
Mean Change in Visual Acuity (Measured at Baseline and at the Month 12 Visit)
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85295
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
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United States
City
Campbell
State/Province
California
ZIP/Postal Code
95008
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United States
City
Fresno
State/Province
California
ZIP/Postal Code
93720
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United States
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
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United States
City
Irvine
State/Province
California
ZIP/Postal Code
92697
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United States
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La Jolla
State/Province
California
ZIP/Postal Code
92037
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United States
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
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United States
City
Palm Desert
State/Province
California
ZIP/Postal Code
92211
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United States
City
Redlands
State/Province
California
ZIP/Postal Code
92374
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United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
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United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95841
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United States
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San Francisco
State/Province
California
ZIP/Postal Code
94109
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United States
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
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United States
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
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United States
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
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United States
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Hamden
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Connecticut
ZIP/Postal Code
06518
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United States
City
New London
State/Province
Connecticut
ZIP/Postal Code
06320
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United States
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Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
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United States
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Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
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United States
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Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
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United States
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Fort Myers
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Florida
ZIP/Postal Code
33912
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United States
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Largo
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Florida
ZIP/Postal Code
33770
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United States
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Melbourne
State/Province
Florida
ZIP/Postal Code
32901
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United States
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Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
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United States
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Pensacola
State/Province
Florida
ZIP/Postal Code
32503
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United States
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Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33711
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United States
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Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
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United States
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Tampa
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Florida
ZIP/Postal Code
33609
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United States
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Winter Haven
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Florida
ZIP/Postal Code
33880
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United States
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Atlanta
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Georgia
ZIP/Postal Code
30322
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United States
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Augusta
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Georgia
ZIP/Postal Code
30909
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United States
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Marietta
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Georgia
ZIP/Postal Code
30060
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United States
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Oak Forest
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Illinois
ZIP/Postal Code
60452
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United States
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Peoria
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Illinois
ZIP/Postal Code
61615
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United States
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West Des Moines
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Iowa
ZIP/Postal Code
50266
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United States
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Leawood
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Kansas
ZIP/Postal Code
66211
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United States
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Shawnee Mission
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Kansas
ZIP/Postal Code
66204
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United States
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Topeka
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Kansas
ZIP/Postal Code
66615
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United States
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Wichita
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Kansas
ZIP/Postal Code
67214
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United States
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Paducah
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Kentucky
ZIP/Postal Code
42001
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United States
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Baltimore
State/Province
Maryland
ZIP/Postal Code
21209
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United States
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Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
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United States
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Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
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United States
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Towson
State/Province
Maryland
ZIP/Postal Code
21204
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United States
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Boston
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Massachusetts
ZIP/Postal Code
02111
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United States
City
Boston
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Massachusetts
ZIP/Postal Code
02114
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United States
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Peabody
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Massachusetts
ZIP/Postal Code
01960
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United States
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
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United States
City
Jackson
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Michigan
ZIP/Postal Code
49202
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United States
City
Lansing
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Michigan
ZIP/Postal Code
48912
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United States
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Southfield
State/Province
Michigan
ZIP/Postal Code
48034
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United States
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Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55435
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United States
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Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
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United States
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Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
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United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
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United States
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Omaha
State/Province
Nebraska
ZIP/Postal Code
68105
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United States
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Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
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United States
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Reno
State/Province
Nevada
ZIP/Postal Code
89502
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United States
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Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
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United States
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Albuquerque
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New Mexico
ZIP/Postal Code
87109
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United States
City
New York
State/Province
New York
ZIP/Postal Code
10021
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United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
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United States
City
Syracuse
State/Province
New York
ZIP/Postal Code
13224
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United States
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
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United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
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United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
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United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44130
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United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
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United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
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United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
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United States
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
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United States
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Philadelphia
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Pennsylvania
ZIP/Postal Code
19104
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United States
City
Philadelphia
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Pennsylvania
ZIP/Postal Code
19107
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United States
City
West Mifflin
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Pennsylvania
ZIP/Postal Code
15122
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United States
City
Ladson
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South Carolina
ZIP/Postal Code
29456
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United States
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
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United States
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
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United States
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
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United States
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Amarillo
State/Province
Texas
ZIP/Postal Code
79106
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United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
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United States
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Fort Worth
State/Province
Texas
ZIP/Postal Code
43212
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United States
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McAllen
State/Province
Texas
ZIP/Postal Code
78503
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United States
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
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United States
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San Antonio
State/Province
Texas
ZIP/Postal Code
78233
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
City
Willow Park
State/Province
Texas
ZIP/Postal Code
76087
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
City
Silverdale
State/Province
Washington
ZIP/Postal Code
98383
Country
United States
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
25606
Country
United States
City
Buenos Aires
ZIP/Postal Code
B1629ODT
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
C1015ABO
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
C1112AAI
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
C1120AAN
Country
Argentina
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
City
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
City
Albury
State/Province
New South Wales
ZIP/Postal Code
2640
Country
Australia
City
Parramatta
State/Province
New South Wales
ZIP/Postal Code
2150
Country
Australia
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
City
Graz
ZIP/Postal Code
8036
Country
Austria
City
Goiânia
ZIP/Postal Code
74210
Country
Brazil
City
São Paulo
ZIP/Postal Code
01525-001
Country
Brazil
City
São Paulo
ZIP/Postal Code
04023-062
Country
Brazil
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1E9
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 3N9
Country
Canada
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3C 1A2
Country
Canada
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4W 1W9
Country
Canada
City
Montral
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
City
Bogota
ZIP/Postal Code
110231
Country
Colombia
City
Medellin
ZIP/Postal Code
050016
Country
Colombia
City
Osijek
ZIP/Postal Code
31000
Country
Croatia
City
Rijeka
ZIP/Postal Code
51000
Country
Croatia
City
Zagreb
ZIP/Postal Code
1000
Country
Croatia
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
City
Prague
ZIP/Postal Code
10 100 34
Country
Czechia
City
Praha
ZIP/Postal Code
169 02
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Czechia
City
Tallinn
ZIP/Postal Code
10138
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Estonia
City
Tallinn
ZIP/Postal Code
11412
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Estonia
City
Helsinki
ZIP/Postal Code
00200
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Finland
City
Kuopio
ZIP/Postal Code
70210
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Finland
City
Creteil
ZIP/Postal Code
94010
Country
France
City
Lyon
ZIP/Postal Code
69003
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France
City
Lyon
ZIP/Postal Code
69317
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France
City
Marseille
ZIP/Postal Code
13008
Country
France
City
Paris
ZIP/Postal Code
75006
Country
France
City
Paris
ZIP/Postal Code
75015
Country
France
City
Paris
ZIP/Postal Code
75019
Country
France
City
Paris
ZIP/Postal Code
75745
Country
France
City
Rouen
ZIP/Postal Code
76100
Country
France
City
Strasbourg
ZIP/Postal Code
67091
Country
France
City
Tours
ZIP/Postal Code
37000
Country
France
City
Aachen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
52074
Country
Germany
City
Munster
State/Province
Norhdhein-Westfalen
ZIP/Postal Code
48145
Country
Germany
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
City
Karlsruhe
ZIP/Postal Code
76133
Country
Germany
City
Lübeck
ZIP/Postal Code
23538
Country
Germany
City
Mainz
ZIP/Postal Code
55131
Country
Germany
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
City
Budapest
ZIP/Postal Code
1076
Country
Hungary
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
City
Budapest
ZIP/Postal Code
1133
Country
Hungary
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
City
Debrecen
ZIP/Postal Code
4012
Country
Hungary
City
Pecs
ZIP/Postal Code
7621
Country
Hungary
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
City
Pita Tikva
ZIP/Postal Code
4941492
Country
Israel
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
City
Ancona
ZIP/Postal Code
60126
Country
Italy
City
Bologna
ZIP/Postal Code
40138
Country
Italy
City
Ferrara
ZIP/Postal Code
44124
Country
Italy
City
Milano
ZIP/Postal Code
20122
Country
Italy
City
Milano
ZIP/Postal Code
20132
Country
Italy
City
Milano
ZIP/Postal Code
20157
Country
Italy
City
Padova
ZIP/Postal Code
35128
Country
Italy
City
Roma
ZIP/Postal Code
00133
Country
Italy
City
Roma
ZIP/Postal Code
00198
Country
Italy
City
Torino
ZIP/Postal Code
10122
Country
Italy
City
Udine
ZIP/Postal Code
33100
Country
Italy
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
City
Riga
ZIP/Postal Code
LV-1050
Country
Latvia
City
Stavanger
ZIP/Postal Code
4016
Country
Norway
City
Bydgoszcz
ZIP/Postal Code
85-631
Country
Poland
City
Katowice
ZIP/Postal Code
40-594
Country
Poland
City
Lodz
ZIP/Postal Code
91-134
Country
Poland
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
City
Coimbra
ZIP/Postal Code
3000-548
Country
Portugal
City
Coimbra
ZIP/Postal Code
3030-163
Country
Portugal
City
Lisboa
ZIP/Postal Code
1050-085
Country
Portugal
City
Lisboa
ZIP/Postal Code
1169-050
Country
Portugal
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
City
Vila Franca de Xira
ZIP/Postal Code
2600-009
Country
Portugal
City
Banska Bystrica
ZIP/Postal Code
975 17
Country
Slovakia
City
Trencin
ZIP/Postal Code
91171
Country
Slovakia
City
Palmas de Gran Canaria
State/Province
Islas Canarias
ZIP/Postal Code
35016
Country
Spain
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
City
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48006
Country
Spain
City
A Coruña
ZIP/Postal Code
15706
Country
Spain
City
Albacete
ZIP/Postal Code
02008
Country
Spain
City
Barcelona
ZIP/Postal Code
08021
Country
Spain
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
City
Barcelona
ZIP/Postal Code
08195
Country
Spain
City
Oviedo
ZIP/Postal Code
33012
Country
Spain
City
Valencia
ZIP/Postal Code
46015
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share individual participant data at this time.
Citations:
PubMed Identifier
30957581
Citation
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.
Results Reference
derived

Learn more about this trial

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

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