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Age-Related Macular DegenerationPhase 3NCT01940887

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

A Phase 3 study testing E10030 and bevacizumab or aflibercept in people with Age-Related Macular Degeneration, run by Ophthotech Corporation at 207 sites in 22 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Age-Related Macular Degeneration
What is being tested?
E10030 and bevacizumab or aflibercept
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
645 participants
Where
207 sitesin 22 countries
Study dates
May 2014to Sep 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects of either gender aged ≥ 50 years
  • Active subfoveal choroidal neovascularization (CNV) secondary to AMD
  • Presence of sub-retinal hyper-reflective material (SD-OCT)

Who cannot join

  • 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

Trial locations and contacts

207 sites in 22 countries.

207 sites in 22 countries

United States100 sites

  • Study site

    Abilene, Texas, 79606

  • Study site

    Albuquerque, New Mexico, 87109

  • Study site

    Altamonte Springs, Florida, 32701

  • Study site

    Amarillo, Texas, 79106

  • Study site

    Asheville, North Carolina, 28803

  • Study site

    Atlanta, Georgia, 30322

  • Study site

    Augusta, Georgia, 30909

  • Study site

    Aurora, Colorado, 80045

  • Study site

    Baltimore, Maryland, 21209

  • Study site

    Bellevue, Washington, 98004

  • Study site

    Boston, Massachusetts, 02111

  • Study site

    Boston, Massachusetts, 02114

  • Study site

    Boynton Beach, Florida, 33426

  • Study site

    Camp Hill, Pennsylvania, 17011

  • Study site

    Campbell, California, 95008

  • Study site

    Chesterfield, Missouri, 63017

  • Study site

    Chevy Chase, Maryland, 20815

  • Study site

    Cleveland, Ohio, 44122

  • Study site

    Cleveland, Ohio, 44130

  • Study site

    Colorado Springs, Colorado, 80909

  • Study site

    Columbus, Ohio, 43212

  • Study site

    Dallas, Texas, 75231

  • Study site

    Denver, Colorado, 80210

  • Study site

    Fort Lauderdale, Florida, 33308

  • Study site

    Fort Myers, Florida, 33912

  • Study site

    Fort Worth, Texas, 43212

  • Study site

    Fresno, California, 93720

  • Study site

    Fullerton, California, 92835

  • Study site

    Gilbert, Arizona, 85295

  • Study site

    Golden, Colorado, 80401

  • Study site

    Hagerstown, Maryland, 21740

  • Study site

    Hamden, Connecticut, 06518

  • Study site

    Irvine, California, 92697

  • Study site

    Jackson, Michigan, 49202

  • Study site

    La Jolla, California, 92037

  • Study site

    Ladson, South Carolina, 29456

  • Study site

    Lansing, Michigan, 48912

  • Study site

    Largo, Florida, 33770

  • Study site

    Las Vegas, Nevada, 89144

  • Study site

    Lawrenceville, New Jersey, 08648

  • Study site

    Leawood, Kansas, 66211

  • Study site

    Marietta, Georgia, 30060

  • Study site

    McAllen, Texas, 78503

  • Study site

    Melbourne, Florida, 32901

  • Study site

    Minneapolis, Minnesota, 55435

  • Study site

    Morgantown, West Virginia, 25606

  • Study site

    Mountain View, California, 94040

  • Study site

    New London, Connecticut, 06320

  • Study site

    New York, New York, 10021

  • Study site

    Oak Forest, Illinois, 60452

  • Study site

    Oklahoma City, Oklahoma, 73104

  • Study site

    Omaha, Nebraska, 68105

  • Study site

    Paducah, Kentucky, 42001

  • Study site

    Palm Beach Gardens, Florida, 33410

  • Study site

    Palm Desert, California, 92211

  • Study site

    Peabody, Massachusetts, 01960

  • Study site

    Pensacola, Florida, 32503

  • Study site

    Peoria, Illinois, 61615

  • Study site

    Philadelphia, Pennsylvania, 19104

  • Study site

    Philadelphia, Pennsylvania, 19107

  • Study site

    Phoenix, Arizona, 85014

  • Study site

    Plano, Texas, 75093

  • Study site

    Portland, Oregon, 97210

  • Study site

    Portland, Oregon, 97239

  • Study site

    Rapid City, South Dakota, 57701

  • Study site

    Redlands, California, 92374

  • Study site

    Reno, Nevada, 89502

  • Study site

    Richmond, Virginia, 23235

  • Study site

    Rochester, New York, 14620

  • Study site

    Sacramento, California, 95819

  • Study site

    Sacramento, California, 95841

  • Study site

    Salt Lake City, Utah, 84107

  • Study site

    Salt Lake City, Utah, 84132

  • Study site

    San Antonio, Texas, 78233

  • Study site

    San Antonio, Texas, 78240

  • Study site

    San Francisco, California, 94109

  • Study site

    Santa Ana, California, 92705

  • Study site

    Shawnee Mission, Kansas, 66204

  • Study site

    Silverdale, Washington, 98383

  • Study site

    Southfield, Michigan, 48034

  • Study site

    St Louis, Missouri, 63110

  • Study site

    St Louis, Missouri, 63128

  • Study site

    St. Petersburg, Florida, 33711

  • Study site

    Syracuse, New York, 13224

  • Study site

    Tallahassee, Florida, 32308

  • Study site

    Tampa, Florida, 33609

  • Study site

    Topeka, Kansas, 66615

  • Study site

    Towson, Maryland, 21204

  • Study site

    Tucson, Arizona, 85704

  • Study site

    Tucson, Arizona, 85710

  • Study site

    Ventura, California, 93003

  • Study site

    Virginia Beach, Virginia, 23462

  • Study site

    West Columbia, South Carolina, 29169

  • Study site

    West Des Moines, Iowa, 50266

  • Study site

    West Mifflin, Pennsylvania, 15122

  • Study site

    Wichita, Kansas, 67214

  • Study site

    Willow Park, Texas, 76087

  • Study site

    Winston-Salem, North Carolina, 27157

  • Study site

    Winter Haven, Florida, 33880

  • Study site

    Worcester, Massachusetts, 01605

Other trials in United States

France11 sites

  • Study site

    Créteil, 94010

  • Study site

    Lyon, 69003

  • Study site

    Lyon, 69317

  • Study site

    Marseille, 13008

  • Study site

    Paris, 75006

  • Study site

    Paris, 75015

  • Study site

    Paris, 75019

  • Study site

    Paris, 75745

  • Study site

    Rouen, 76100

  • Study site

    Strasbourg, 67091

  • Study site

    Tours, 37000

Other trials in France

Italy11 sites

  • Study site

    Ancona, 60126

  • Study site

    Bologna, 40138

  • Study site

    Ferrara, 44124

  • Study site

    Milan, 20122

  • Study site

    Milan, 20132

  • Study site

    Milan, 20157

  • Study site

    Padova, 35128

  • Study site

    Roma, 00133

  • Study site

    Roma, 00198

  • Study site

    Torino, 10122

  • Study site

    Udine, 33100

Other trials in Italy

Spain11 sites

  • Study site

    A Coruña, 15706

  • Study site

    Albacete, 02008

  • Study site

    Barcelona, 08021

  • Study site

    Barcelona, 08022

  • Study site

    Barcelona, 08035

  • Study site

    Barcelona, 08195

  • Study site

    Bilbao, Vizcaya, 48006

  • Study site

    Las Palmas de Gran Canaria, Canary Islands, 35016

  • Study site

    Oviedo, 33012

  • Study site

    Pamplona, Navarre, 31008

  • Study site

    Valencia, 46015

Other trials in Spain

Germany10 sites

  • Study site

    Aachen, North Rhine-Westphalia, 52074

  • Study site

    Göttingen, 37075

  • Study site

    Hamburg, 20246

  • Study site

    Karlsruhe, 76133

  • Study site

    Kiel, Schleswig-Holstein, 24105

  • Study site

    Leipzig, Saxony, 04103

  • Study site

    Lübeck, 23538

  • Study site

    Mainz, 55131

  • Study site

    Münster, Norhdhein-Westfalen, 48145

  • Study site

    Tübingen, 72076

Other trials in Germany

Hungary9 sites

  • Study site

    Budapest, 1076

  • Study site

    Budapest, 1083

  • Study site

    Budapest, 1106

  • Study site

    Budapest, 1133

  • Study site

    Budapest, 1145

  • Study site

    Debrecen, 4012

  • Study site

    Pécs, 7621

  • Study site

    Szeged, 6720

  • Study site

    Veszprém, 8200

Other trials in Hungary

Argentina6 sites

  • Study site

    Buenos Aires, B1629ODT

  • Study site

    Buenos Aires, C1015ABO

  • Study site

    Buenos Aires, C1112AAI

  • Study site

    Buenos Aires, C1120AAN

  • Study site

    Córdoba, 5000

  • Study site

    Santa Fe, 2000

Other trials in Argentina

Israel6 sites

  • Study site

    Haifa, 3109601

  • Study site

    Jerusalem, 91120

  • Study site

    Kfar Saba, 4428164

  • Study site

    Pita Tikva, 4941492

  • Study site

    Rehovot, 76100

  • Study site

    Tel Aviv, 64239

Other trials in Israel

Portugal6 sites

  • Study site

    Coimbra, 3000-548

  • Study site

    Coimbra, 3030-163

  • Study site

    Lisbon, 1050-085

  • Study site

    Lisbon, 1169-050

  • Study site

    Porto, 4200-319

  • Study site

    Vila Franca de Xira, 2600-009

Other trials in Portugal

Australia5 sites

  • Study site

    Albury, New South Wales, 2640

  • Study site

    East Melbourne, Victoria, 3002

  • Study site

    Parramatta, New South Wales, 2150

  • Study site

    Sydney, New South Wales, 2000

  • Study site

    Westmead, New South Wales, 2145

Other trials in Australia

Canada5 sites

  • Study site

    Mississauga, Ontario, L4W 1W9

  • Study site

    Montral, Quebec, H1T 2M4

  • Study site

    Vancouver, British Columbia, V5Z 1E9

  • Study site

    Vancouver, British Columbia, V5Z 3N9

  • Study site

    Winnipeg, Manitoba, R3C 1A2

Other trials in Canada

Czechia5 sites

  • Study site

    Brno, 625 00

  • Study site

    Hradec Králové, 500 05

  • Study site

    Olomouc, 779 00

  • Study site

    Prague, 10 100 34

  • Study site

    Prague, 169 02

Other trials in Czechia

Poland4 sites

  • Study site

    Bydgoszcz, 85-631

  • Study site

    Katowice, 40-594

  • Study site

    Lodz, 91-134

  • Study site

    Wroclaw, 50-556

Other trials in Poland

Brazil3 sites

  • Study site

    Goiânia, 74210

  • Study site

    São Paulo, 01525-001

  • Study site

    São Paulo, 04023-062

Other trials in Brazil

Croatia3 sites

  • Study site

    Osijek, 31000

  • Study site

    Rijeka, 51000

  • Study site

    Zagreb, 1000

Other trials in Croatia

Colombia2 sites

  • Study site

    Bogotá, 110231

  • Study site

    Medellín, 050016

Other trials in Colombia

Estonia2 sites

  • Study site

    Tallinn, 10138

  • Study site

    Tallinn, 11412

Other trials in Estonia

Finland2 sites

  • Study site

    Helsinki, 00200

  • Study site

    Kuopio, 70210

Other trials in Finland

Latvia2 sites

  • Study site

    Riga, LV-1002

  • Study site

    Riga, LV-1050

Other trials in Latvia

Slovakia2 sites

  • Study site

    Banská Bystrica, 975 17

  • Study site

    Trenčín, 91171

Other trials in Slovakia

Austria1 site

  • Study site

    Graz, 8036

Other trials in Austria

Norway1 site

  • Study site

    Stavanger, 4016

Other trials in Norway

About this study

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.

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).

Read the 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

Being tested
E10030, bevacizumab or aflibercept, E10030 sham injection
Keywords
Wet AMD, choroidal neovascularization, Fovista®, E10030, Avastin®, Eylea®
Medical subject headings
Macular Degeneration, Choroidal Neovascularization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • E10030Drug

    Also called Fovista®

  • bevacizumab or afliberceptDrug

    Also called Avastin®, Eylea®

    Patients are randomized to receive either bevacizumab or aflibercept

  • E10030 sham injectionDrug

    Also called Sham

    Pressure on the eye with a syringe with no needle

Study groups in NCT01940887
Study groupRoleWhat they receive
E10030 + bevacizumab or afliberceptExperimentalE10030 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection
Receives: Drug: E10030; Drug: bevacizumab or aflibercept
Sham + bevacizumab or afliberceptActive comparatorE10030 sham injection + bevacizumab 1.25 mg intravitreal injection or aflibercept 2 mg intravitreal injection
Receives: Drug: bevacizumab or aflibercept; Drug: E10030 sham injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2013 (estimated)
  2. Study startMay 2014
  3. Primary completionJun 2017
  4. Study completionSep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
645 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01940887
Sponsor's protocol ID
OPH1004
Status last verified
Sep 2020
First submitted
9 Sep 2013
Last updated
31 Oct 2024
Data monitoring committee
Yes
Individual data sharing
No: 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/.

Publications

  • 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.

    PubMed 30957581

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing E10030 and bevacizumab or aflibercept in people with Age-Related Macular Degeneration, run by Ophthotech Corporation at 207 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 207 sites in United States, France, Italy, Spain, Germany and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change in Visual Acuity (Measured at Baseline and at the Month 12 Visit) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01940887, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2024.

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