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

Primary Purpose

Age-Related Macular Degeneration

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
E10030
ranibizumab
E10030 sham intravitreal 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, Lucentis®

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 + ranibizumab

Sham + ranibizumab

Arm Description

E10030 1.5 mg intravitreal injection + ranibizumab 0.5 mg intravitreal injection

E10030 sham intravitreal injection + ranibizumab 0.5 mg intravitreal injection

Outcomes

Primary Outcome Measures

Mean Change in Visual Acuity From Baseline to 12 Months
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.

Secondary Outcome Measures

Full Information

First Posted
September 9, 2013
Last Updated
August 13, 2018
Sponsor
Ophthotech Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01940900
Brief Title
A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Lucentis® 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 Lucentis® Compared to Lucentis® Monotherapy in Subjects With Subfoveal Neovascular Age-related Macular Degeneration.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Terminated
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (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 Lucentis® compared to Lucentis® 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 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).

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, Lucentis®

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
E10030 + ranibizumab
Arm Type
Experimental
Arm Description
E10030 1.5 mg intravitreal injection + ranibizumab 0.5 mg intravitreal injection
Arm Title
Sham + ranibizumab
Arm Type
Active Comparator
Arm Description
E10030 sham intravitreal injection + ranibizumab 0.5 mg intravitreal injection
Intervention Type
Drug
Intervention Name(s)
E10030
Other Intervention Name(s)
Fovista®
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
Lucentis®
Intervention Type
Drug
Intervention Name(s)
E10030 sham intravitreal 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 From Baseline to 12 Months
Description
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.
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
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
City
Harvey
State/Province
Illinois
ZIP/Postal Code
60426
Country
United States
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
City
Shawnee Mission
State/Province
Kansas
ZIP/Postal Code
66204
Country
United States
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21209
Country
United States
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
City
Peabody
State/Province
Massachusetts
ZIP/Postal Code
01960
Country
United States
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
City
Syracuse
State/Province
New York
ZIP/Postal Code
13224
Country
United States
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
City
West Columbia
State/Province
South Carolina
ZIP/Postal Code
29169
Country
United States
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
City
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
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23226
Country
United States
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
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
C1120AAN
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
C1122AAI
Country
Argentina
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
City
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
City
East Melbourne
ZIP/Postal Code
3002
Country
Australia
City
Malvern
ZIP/Postal Code
3144
Country
Australia
City
Nedlands
ZIP/Postal Code
6009
Country
Australia
City
Parramatta
ZIP/Postal Code
2150
Country
Australia
City
Sydney
ZIP/Postal Code
2000
Country
Australia
City
Westmead
ZIP/Postal Code
2145
Country
Australia
City
Bogota
ZIP/Postal Code
110311
Country
Colombia
City
Cali
ZIP/Postal Code
76001000
Country
Colombia
City
Medellin
Country
Colombia
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
City
Odense
ZIP/Postal Code
5000
Country
Denmark
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
City
Créteil
ZIP/Postal Code
94010
Country
France
City
Lyon
ZIP/Postal Code
69003
Country
France
City
Lyon
ZIP/Postal Code
69317
Country
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
ZIP/Postal Code
52057
Country
Germany
City
Bonn
ZIP/Postal Code
53127
Country
Germany
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
City
Karlsruhe
ZIP/Postal Code
76131
Country
Germany
City
Kiel
ZIP/Postal Code
24105
Country
Germany
City
Köln
ZIP/Postal Code
50924
Country
Germany
City
Leipzig
ZIP/Postal Code
D-04103
Country
Germany
City
Luebeck
ZIP/Postal Code
23538
Country
Germany
City
Mainz
ZIP/Postal Code
55131
Country
Germany
City
Muenchen
ZIP/Postal Code
80336
Country
Germany
City
Muenster
ZIP/Postal Code
48165
Country
Germany
City
München
ZIP/Postal Code
81675
Country
Germany
City
Münster
ZIP/Postal Code
48145
Country
Germany
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
City
Budapest
ZIP/Postal Code
1076
Country
Hungary
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
City
Budapest
ZIP/Postal Code
1133
Country
Hungary
City
Budapest
ZIP/Postal Code
H-1083
Country
Hungary
City
Budapest
ZIP/Postal Code
H-1145
Country
Hungary
City
Debrecen
ZIP/Postal Code
H-4012
Country
Hungary
City
Magyarszék
ZIP/Postal Code
8200
Country
Hungary
City
Pecs
ZIP/Postal Code
7621
Country
Hungary
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
City
Haifa
ZIP/Postal Code
31096
Country
Israel
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
City
Kfar-Saba
ZIP/Postal Code
4428164
Country
Israel
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
City
Bilbao
ZIP/Postal Code
48006
Country
Spain
City
Las Palmas
ZIP/Postal Code
35016
Country
Spain
City
Navarro
ZIP/Postal Code
31008
Country
Spain
City
Sant Cugat Del Vallès
ZIP/Postal Code
08195
Country
Spain
City
Valencia
ZIP/Postal Code
46015
Country
Spain
City
Ankara
ZIP/Postal Code
6100
Country
Turkey
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
City
Izmir
ZIP/Postal Code
35340
Country
Turkey

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 Lucentis® Compared to Lucentis® Monotherapy

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