search
Back to results

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 8, 2018
Sponsor
Ophthotech Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT01944839
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
619 (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
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
City
San Francisco
State/Province
California
ZIP/Postal Code
94107
Country
United States
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93103
Country
United States
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
City
New London
State/Province
Connecticut
ZIP/Postal Code
06320
Country
United States
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33907
Country
United States
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34233
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62704-2173
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
City
Leawood
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
City
Jackson
State/Province
Michigan
ZIP/Postal Code
49202
Country
United States
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48034
Country
United States
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
City
Northfield
State/Province
New Jersey
ZIP/Postal Code
08225
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
City
Shirley
State/Province
New York
ZIP/Postal Code
11967
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
City
Ashland
State/Province
Oregon
ZIP/Postal Code
97520
Country
United States
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
City
Ladson
State/Province
South Carolina
ZIP/Postal Code
29456
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
City
Graz
ZIP/Postal Code
8036
Country
Austria
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
City
Linz
ZIP/Postal Code
4021
Country
Austria
City
Wien
ZIP/Postal Code
1090
Country
Austria
City
Deurne
State/Province
Antwerpen
ZIP/Postal Code
2100
Country
Belgium
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
City
Goiânia
State/Province
Goiás
ZIP/Postal Code
74210
Country
Brazil
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90440
Country
Brazil
City
Minas Gerais
ZIP/Postal Code
30150-270
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
01525-001
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
04021-050
Country
Brazil
City
Sao Paulo
ZIP/Postal Code
04023-062
Country
Brazil
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2H 0C8
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 3N9
Country
Canada
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3P 1A2
Country
Canada
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4W 1W9
Country
Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 0M7
Country
Canada
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
City
Kralovice
ZIP/Postal Code
500 05
Country
Czechia
City
Libeň
ZIP/Postal Code
401 13
Country
Czechia
City
Olomouc
ZIP/Postal Code
775 20
Country
Czechia
City
Prague
ZIP/Postal Code
10 100 34
Country
Czechia
City
Praha
ZIP/Postal Code
6 169 02
Country
Czechia
City
Harju
ZIP/Postal Code
11412
Country
Estonia
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
City
Tartu
ZIP/Postal Code
51003
Country
Estonia
City
Ancona
ZIP/Postal Code
60126
Country
Italy
City
Bologna
ZIP/Postal Code
40138
Country
Italy
City
Ferrara
ZIP/Postal Code
44121
Country
Italy
City
Firenze
ZIP/Postal Code
50134
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-1050
Country
Latvia
City
Riga
ZIP/Postal Code
LV-11002
Country
Latvia
City
Bydgoszcz
ZIP/Postal Code
85-631
Country
Poland
City
Katowice
ZIP/Postal Code
43-300
Country
Poland
City
Lodz
ZIP/Postal Code
91 -134
Country
Poland
City
Warszawa
ZIP/Postal Code
02005
Country
Poland
City
Wroclaw
ZIP/Postal Code
50-556
Country
Poland
City
Banska Bystrica
ZIP/Postal Code
975 17
Country
Slovakia
City
Bratislava
ZIP/Postal Code
826 06
Country
Slovakia
City
Trencin
ZIP/Postal Code
91171
Country
Slovakia
City
Basel
ZIP/Postal Code
4102
Country
Switzerland
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
City
Lausanne
ZIP/Postal Code
1000
Country
Switzerland
City
Zurich
ZIP/Postal Code
8063
Country
Switzerland
City
Belfast
ZIP/Postal Code
BT12 6BA
Country
United Kingdom
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
City
London
ZIP/Postal Code
EC1V 2PD
Country
United Kingdom
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
City
Surrey Quays
ZIP/Postal Code
GU17UJ
Country
United Kingdom

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

We'll reach out to this number within 24 hrs