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

October 19, 2024 updated by: Ophthotech Corporation

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.

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
645

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1015ABO
      • Buenos Aires, Argentina, B1629ODT
      • Buenos Aires, Argentina, C1120AAN
      • Buenos Aires, Argentina, C1112AAI
      • Cordoba, Argentina, 5000
      • Santa Fe, Argentina, 2000
  • Australia
    • New South Wales
      • Albury, New South Wales, Australia, 2640
      • Parramatta, New South Wales, Australia, 2150
      • Sydney, New South Wales, Australia, 2000
      • Westmead, New South Wales, Australia, 2145
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
  • Austria
      • Graz, Austria, 8036
  • Brazil
      • Goiânia, Brazil, 74210
      • São Paulo, Brazil, 01525-001
      • São Paulo, Brazil, 04023-062
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 3N9
      • Vancouver, British Columbia, Canada, V5Z 1E9
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3C 1A2
    • Ontario
      • Mississauga, Ontario, Canada, L4W 1W9
    • Quebec
      • Montral, Quebec, Canada, H1T 2M4
  • Colombia
      • Bogota, Colombia, 110231
      • Medellin, Colombia, 050016
  • Croatia
      • Osijek, Croatia, 31000
      • Rijeka, Croatia, 51000
      • Zagreb, Croatia, 1000
  • Czechia
      • Brno, Czechia, 625 00
      • Hradec Kralove, Czechia, 500 05
      • Olomouc, Czechia, 779 00
      • Prague, Czechia, 10 100 34
      • Praha, Czechia, 169 02
  • Estonia
      • Tallinn, Estonia, 10138
      • Tallinn, Estonia, 11412
  • Finland
      • Helsinki, Finland, 00200
      • Kuopio, Finland, 70210
  • France
      • Creteil, France, 94010
      • Lyon, France, 69317
      • Lyon, France, 69003
      • Marseille, France, 13008
      • Paris, France, 75015
      • Paris, France, 75019
      • Paris, France, 75006
      • Paris, France, 75745
      • Rouen, France, 76100
      • Strasbourg, France, 67091
      • Tours, France, 37000
  • Germany
      • Göttingen, Germany, 37075
      • Hamburg, Germany, 20246
      • Karlsruhe, Germany, 76133
      • Lübeck, Germany, 23538
      • Mainz, Germany, 55131
      • Tübingen, Germany, 72076
    • Nordrhein-Westfalen
      • Aachen, Nordrhein-Westfalen, Germany, 52074
    • Norhdhein-Westfalen
      • Munster, Norhdhein-Westfalen, Germany, 48145
    • Sachsen
      • Leipzig, Sachsen, Germany, 04103
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
  • Hungary
      • Budapest, Hungary, 1083
      • Budapest, Hungary, 1145
      • Budapest, Hungary, 1106
      • Budapest, Hungary, 1133
      • Budapest, Hungary, 1076
      • Debrecen, Hungary, 4012
      • Pecs, Hungary, 7621
      • Szeged, Hungary, 6720
      • Veszprem, Hungary, 8200
  • Israel
      • Haifa, Israel, 3109601
      • Jerusalem, Israel, 91120
      • Kfar Saba, Israel, 4428164
      • Pita Tikva, Israel, 4941492
      • Rehovot, Israel, 76100
      • Tel Aviv, Israel, 64239
  • Italy
      • Ancona, Italy, 60126
      • Bologna, Italy, 40138
      • Ferrara, Italy, 44124
      • Milano, Italy, 20122
      • Milano, Italy, 20132
      • Milano, Italy, 20157
      • Padova, Italy, 35128
      • Roma, Italy, 00133
      • Roma, Italy, 00198
      • Torino, Italy, 10122
      • Udine, Italy, 33100
  • Latvia
      • Riga, Latvia, LV-1050
      • Riga, Latvia, LV-1002
  • Norway
      • Stavanger, Norway, 4016
  • Poland
      • Bydgoszcz, Poland, 85-631
      • Katowice, Poland, 40-594
      • Lodz, Poland, 91-134
      • Wroclaw, Poland, 50-556
  • Portugal
      • Coimbra, Portugal, 3000-548
      • Coimbra, Portugal, 3030-163
      • Lisboa, Portugal, 1169-050
      • Lisboa, Portugal, 1050-085
      • Porto, Portugal, 4200-319
      • Vila Franca de Xira, Portugal, 2600-009
  • Slovakia
      • Banska Bystrica, Slovakia, 975 17
      • Trencin, Slovakia, 91171
  • Spain
      • A Coruña, Spain, 15706
      • Albacete, Spain, 02008
      • Barcelona, Spain, 08035
      • Barcelona, Spain, 08195
      • Barcelona, Spain, 08022
      • Barcelona, Spain, 08021
      • Oviedo, Spain, 33012
      • Valencia, Spain, 46015
    • Islas Canarias
      • Palmas de Gran Canaria, Islas Canarias, Spain, 35016
    • Navarra
      • Pamplona, Navarra, Spain, 31008
    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48006
  • United States
    • Arizona
      • Gilbert, Arizona, United States, 85295
      • Phoenix, Arizona, United States, 85014
      • Tucson, Arizona, United States, 85704
      • Tucson, Arizona, United States, 85710
    • California
      • Campbell, California, United States, 95008
      • Fresno, California, United States, 93720
      • Fullerton, California, United States, 92835
      • Irvine, California, United States, 92697
      • La Jolla, California, United States, 92037
      • Mountain View, California, United States, 94040
      • Palm Desert, California, United States, 92211
      • Redlands, California, United States, 92374
      • Sacramento, California, United States, 95819
      • Sacramento, California, United States, 95841
      • San Francisco, California, United States, 94109
      • Santa Ana, California, United States, 92705
      • Ventura, California, United States, 93003
    • Colorado
      • Aurora, Colorado, United States, 80045
      • Colorado Springs, Colorado, United States, 80909
      • Denver, Colorado, United States, 80210
      • Golden, Colorado, United States, 80401
    • Connecticut
      • Hamden, Connecticut, United States, 06518
      • New London, Connecticut, United States, 06320
    • Florida
      • Altamonte Springs, Florida, United States, 32701
      • Boynton Beach, Florida, United States, 33426
      • Fort Lauderdale, Florida, United States, 33308
      • Fort Myers, Florida, United States, 33912
      • Largo, Florida, United States, 33770
      • Melbourne, Florida, United States, 32901
      • Palm Beach Gardens, Florida, United States, 33410
      • Pensacola, Florida, United States, 32503
      • Saint Petersburg, Florida, United States, 33711
      • Tallahassee, Florida, United States, 32308
      • Tampa, Florida, United States, 33609
      • Winter Haven, Florida, United States, 33880
    • Georgia
      • Atlanta, Georgia, United States, 30322
      • Augusta, Georgia, United States, 30909
      • Marietta, Georgia, United States, 30060
    • Illinois
      • Oak Forest, Illinois, United States, 60452
      • Peoria, Illinois, United States, 61615
    • Iowa
      • West Des Moines, Iowa, United States, 50266
    • Kansas
      • Leawood, Kansas, United States, 66211
      • Shawnee Mission, Kansas, United States, 66204
      • Topeka, Kansas, United States, 66615
      • Wichita, Kansas, United States, 67214
    • Kentucky
      • Paducah, Kentucky, United States, 42001
    • Maryland
      • Baltimore, Maryland, United States, 21209
      • Chevy Chase, Maryland, United States, 20815
      • Hagerstown, Maryland, United States, 21740
      • Towson, Maryland, United States, 21204
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
      • Boston, Massachusetts, United States, 02114
      • Peabody, Massachusetts, United States, 01960
      • Worcester, Massachusetts, United States, 01605
    • Michigan
      • Jackson, Michigan, United States, 49202
      • Lansing, Michigan, United States, 48912
      • Southfield, Michigan, United States, 48034
    • Minnesota
      • Minneapolis, Minnesota, United States, 55435
    • Missouri
      • Chesterfield, Missouri, United States, 63017
      • Saint Louis, Missouri, United States, 63110
      • Saint Louis, Missouri, United States, 63128
    • Nebraska
      • Omaha, Nebraska, United States, 68105
    • Nevada
      • Las Vegas, Nevada, United States, 89144
      • Reno, Nevada, United States, 89502
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
    • New York
      • New York, New York, United States, 10021
      • Rochester, New York, United States, 14620
      • Syracuse, New York, United States, 13224
    • North Carolina
      • Asheville, North Carolina, United States, 28803
      • Winston-Salem, North Carolina, United States, 27157
    • Ohio
      • Cleveland, Ohio, United States, 44122
      • Cleveland, Ohio, United States, 44130
      • Columbus, Ohio, United States, 43212
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
    • Oregon
      • Portland, Oregon, United States, 97239
      • Portland, Oregon, United States, 97210
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
      • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia, Pennsylvania, United States, 19107
      • West Mifflin, Pennsylvania, United States, 15122
    • South Carolina
      • Ladson, South Carolina, United States, 29456
      • West Columbia, South Carolina, United States, 29169
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
    • Texas
      • Abilene, Texas, United States, 79606
      • Amarillo, Texas, United States, 79106
      • Dallas, Texas, United States, 75231
      • Fort Worth, Texas, United States, 43212
      • McAllen, Texas, United States, 78503
      • Plano, Texas, United States, 75093
      • San Antonio, Texas, United States, 78240
      • San Antonio, Texas, United States, 78233
      • Willow Park, Texas, United States, 76087
    • Utah
      • Salt Lake City, Utah, United States, 84132
      • Salt Lake City, Utah, United States, 84107
    • Virginia
      • Richmond, Virginia, United States, 23235
      • Virginia Beach, Virginia, United States, 23462
    • Washington
      • Bellevue, Washington, United States, 98004
      • Silverdale, Washington, United States, 98383
    • West Virginia
      • Morgantown, West Virginia, United States, 25606

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: E10030 + bevacizumab or aflibercept
E10030 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection
Drug: E10030
Other Names:
  • Fovista®
Drug: bevacizumab or aflibercept
Patients are randomized to receive either bevacizumab or aflibercept
Other Names:
  • Avastin®
  • Eylea®
Active Comparator: Sham + bevacizumab or aflibercept
E10030 sham injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection
Drug: bevacizumab or aflibercept
Patients are randomized to receive either bevacizumab or aflibercept
Other Names:
  • Avastin®
  • Eylea®
Drug: E10030 sham injection
Pressure on the eye with a syringe with no needle
Other Names:
  • Sham

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean Change in Visual Acuity (Measured at Baseline and at the Month 12 Visit)
Time Frame: 12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ophthotech Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 9, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 12, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 31, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OPH1004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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