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Age-Related Macular DegenerationPhase 3NCT01940900

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

A Phase 3 study testing E10030 and ranibizumab in people with Age-Related Macular Degeneration, run by Ophthotech Corporation at 121 sites in 11 countries.

Terminated

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

Official record
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Trial 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). 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 ranibizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
627 participants
Where
121 sitesin 11 countries
Study dates
Aug 2013to Dec 2016
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

121 sites in 11 countries.

121 sites in 11 countries

United States49 sites

  • Study site

    Asheville, North Carolina, 28803

  • Study site

    Atlanta, Georgia, 30322

  • Study site

    Augusta, Georgia, 30909

  • Study site

    Aurora, Colorado, 80045

  • Study site

    Austin, Texas, 78705

  • Study site

    Baltimore, Maryland, 21209

  • Study site

    Bellevue, Washington, 98004

  • Study site

    Boynton Beach, Florida, 33426

  • Study site

    Charlotte, North Carolina, 28210

  • Study site

    Cleveland, Ohio, 44122

  • Study site

    Cleveland, Ohio, 44130

  • Study site

    Dallas, Texas, 75231

  • Study site

    Fort Lauderdale, Florida, 33308

  • Study site

    Fort Myers, Florida, 33912

  • Study site

    Fresno, California, 93720

  • Study site

    Golden, Colorado, 80401

  • Study site

    Greenville, South Carolina, 29605

  • Study site

    Hagerstown, Maryland, 21740

  • Study site

    Harvey, Illinois, 60426

  • Study site

    Houston, Texas, 77030

  • Study site

    La Jolla, California, 92093

  • Study site

    Largo, Florida, 33770

  • Study site

    Lawrenceville, New Jersey, 08648

  • Study site

    Loma Linda, California, 92354

  • Study site

    McAllen, Texas, 78503

  • Study site

    Minneapolis, Minnesota, 55435

  • Study site

    Mountain View, California, 94040

  • Study site

    Nashville, Tennessee, 37203

  • Study site

    New York, New York, 10022

  • Study site

    Oklahoma City, Oklahoma, 73104

  • Study site

    Orlando, Florida, 32806

  • Study site

    Peabody, Massachusetts, 01960

  • Study site

    Rapid City, South Dakota, 57701

  • Study site

    Richmond, Virginia, 23226

  • Study site

    Sacramento, California, 95819

  • Study site

    Salt Lake City, Utah, 84107

  • Study site

    San Antonio, Texas, 78233

  • Study site

    San Antonio, Texas, 78240

  • Study site

    Santa Ana, California, 92705

  • Study site

    Shawnee Mission, Kansas, 66204

  • Study site

    Syracuse, New York, 13224

  • Study site

    Tucson, Arizona, 85704

  • Study site

    Tucson, Arizona, 85710

  • Study site

    Virginia Beach, Virginia, 23454

  • Study site

    West Columbia, South Carolina, 29169

  • Study site

    West Des Moines, Iowa, 50266

  • Study site

    Wichita, Kansas, 67214

  • Study site

    Winston-Salem, North Carolina, 27157

  • Study site

    Worcester, Massachusetts, 01605

Other trials in United States

Germany17 sites

  • Study site

    Aachen, 52057

  • Study site

    Bonn, 53127

  • Study site

    Cologne, 50924

  • Study site

    Freiburg im Breisgau, 79106

  • Study site

    Göttingen, 37075

  • Study site

    Hamburg, 20246

  • Study site

    Heidelberg, 69120

  • Study site

    Karlsruhe, 76131

  • Study site

    Kiel, 24105

  • Study site

    Leipzig, D-04103

  • Study site

    Lübeck, 23538

  • Study site

    Mainz, 55131

  • Study site

    München, 80336

  • Study site

    München, 81675

  • Study site

    Münster, 48145

  • Study site

    Münster, 48165

  • Study site

    Tübingen, 72076

Other trials in Germany

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

Hungary9 sites

  • Study site

    Budapest, 1076

  • Study site

    Budapest, 1106

  • Study site

    Budapest, 1133

  • Study site

    Budapest, H-1083

  • Study site

    Budapest, H-1145

  • Study site

    Debrecen, H-4012

  • Study site

    Magyarszék, 8200

  • Study site

    Pécs, 7621

  • Study site

    Szeged, 6720

Other trials in Hungary

Argentina6 sites

  • Study site

    Buenos Aires, B1629ODT

  • Study site

    Buenos Aires, C1015ABO

  • Study site

    Buenos Aires, C1120AAN

  • Study site

    Buenos Aires, C1122AAI

  • Study site

    Córdoba, 5000

  • Study site

    Santa Fe, 2000

Other trials in Argentina

Australia6 sites

  • Study site

    East Melbourne, 3002

  • Study site

    Malvern, 3144

  • Study site

    Nedlands, 6009

  • Study site

    Parramatta, 2150

  • Study site

    Sydney, 2000

  • Study site

    Westmead, 2145

Other trials in Australia

Israel6 sites

  • Study site

    Haifa, 31096

  • Study site

    Jerusalem, 91120

  • Study site

    Kfar Saba, 4428164

  • Study site

    Petah Tikva, 49100

  • Study site

    Rehovot, 76100

  • Study site

    Tel Aviv, 64239

Other trials in Israel

Spain6 sites

  • Study site

    Barcelona, 08022

  • Study site

    Bilbao, 48006

  • Study site

    Las Palmas, 35016

  • Study site

    Navarro, 31008

  • Study site

    Sant Cugat del Vallès, 08195

  • Study site

    Valencia, 46015

Other trials in Spain

Denmark5 sites

  • Study site

    Aalborg, 9000

  • Study site

    Aarhus C, 8000

  • Study site

    Glostrup Municipality, 2600

  • Study site

    Odense, 5000

  • Study site

    Roskilde, 4000

Other trials in Denmark

Colombia3 sites

  • Study site

    Bogotá, 110311

  • Study site

    Cali, 76001000

  • Study site

    Medellín

Other trials in Colombia

Turkey (Türkiye)3 sites

  • Study site

    Ankara, 6100

  • Study site

    Izmir, 35100

  • Study site

    Izmir, 35340

Other trials in Turkey (Türkiye)

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 Lucentis® Compared to Lucentis® 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 Lucentis® compared to Lucentis® 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 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).

Being tested
E10030, ranibizumab, E10030 sham intravitreal injection
Keywords
Wet AMD, choroidal neovascularization, Fovista®, E10030, Lucentis®
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®

  • ranibizumabDrug

    Also called Lucentis®

  • E10030 sham intravitreal injectionDrug

    Also called Sham

    Pressure on the eye with a syringe with no needle

Study groups in NCT01940900
Study groupRoleWhat they receive
E10030 + ranibizumabExperimentalE10030 1.5 mg intravitreal injection + ranibizumab 0.5 mg intravitreal injection
Receives: Drug: E10030; Drug: ranibizumab
Sham + ranibizumabActive comparatorE10030 sham intravitreal injection + ranibizumab 0.5 mg intravitreal injection
Receives: Drug: ranibizumab; Drug: E10030 sham intravitreal injection

What is being measured

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

  1. 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.

    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 startAug 2013
  3. Primary completionDec 2016
  4. Study completionDec 2016

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
627 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01940900
Sponsor's protocol ID
OPH1003
Status last verified
Aug 2018
First submitted
9 Sep 2013
Last updated
30 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 ranibizumab in people with Age-Related Macular Degeneration, run by Ophthotech Corporation at 121 sites in 11 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 30 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 121 sites in United States, Germany, France, Hungary, Argentina and 6 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 15 Aug 2018). 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 From Baseline to 12 Months (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 NCT01940900, 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 30 Oct 2024.

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