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Age-Related Macular DegenerationPhase 3NCT01944839

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 115 sites in 13 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
619 participants
Where
115 sitesin 13 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

115 sites in 13 countries.

115 sites in 13 countries

United States50 sites

  • Study site

    Abilene, Texas, 79606

  • Study site

    Albuquerque, New Mexico, 87109

  • Study site

    Altamonte Springs, Florida, 32701

  • Study site

    Ashland, Oregon, 97520

  • Study site

    Austin, Texas, 78705

  • Study site

    Bakersfield, California, 93309

  • Study site

    Beverly Hills, California, 90211

  • Study site

    Boston, Massachusetts, 02111

  • Study site

    Boston, Massachusetts, 02114

  • Study site

    Bridgeport, Connecticut, 06606

  • Study site

    Camp Hill, Pennsylvania, 17011

  • Study site

    Chevy Chase, Maryland, 20815

  • Study site

    Cincinnati, Ohio, 45242

  • Study site

    Cleveland, Ohio, 44195

  • Study site

    Colorado Springs, Colorado, 80909

  • Study site

    Fairfax, Virginia, 22031

  • Study site

    Fort Myers, Florida, 33907

  • Study site

    Great Neck, New York, 11021

  • Study site

    Indianapolis, Indiana, 46290

  • Study site

    Jackson, Michigan, 49202

  • Study site

    Ladson, South Carolina, 29456

  • Study site

    Las Vegas, Nevada, 89135

  • Study site

    Leawood, Kansas, 66211

  • Study site

    Lexington, Kentucky, 40509

  • Study site

    Lexington, Kentucky, 40536

  • Study site

    Los Angeles, California, 90095

  • Study site

    Louisville, Kentucky, 40202

  • Study site

    Madison, Wisconsin, 53705

  • Study site

    Marietta, Georgia, 30060

  • Study site

    Nashville, Tennessee, 37232

  • Study site

    New London, Connecticut, 06320

  • Study site

    New Orleans, Louisiana, 70121

  • Study site

    Northfield, New Jersey, 08225

  • Study site

    Philadelphia, Pennsylvania, 19107

  • Study site

    Phoenix, Arizona, 85014

  • Study site

    Pittsburgh, Pennsylvania, 15212

  • Study site

    Portsmouth, New Hampshire, 03801

  • Study site

    Rochester, Minnesota, 55905

  • Study site

    Salt Lake City, Utah, 84132

  • Study site

    San Francisco, California, 94107

  • Study site

    Santa Barbara, California, 93103

  • Study site

    Sarasota, Florida, 34233

  • Study site

    Shirley, New York, 11967

  • Study site

    Southfield, Michigan, 48034

  • Study site

    Springfield, Illinois, 62704-2173

  • Study site

    St Louis, Missouri, 63110

  • Study site

    Tampa, Florida, 33609

  • Study site

    Tampa, Florida, 33612

  • Study site

    Tyler, Texas, 75701

  • Study site

    Winter Haven, Florida, 33880

Other trials in United States

Italy12 sites

  • Study site

    Ancona, 60126

  • Study site

    Bologna, 40138

  • Study site

    Ferrara, 44121

  • Study site

    Florence, 50134

  • 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

Canada11 sites

  • Study site

    Calgary, Alberta, T2H 0C8

  • Study site

    Halifax, Nova Scotia, B3H 2Y9

  • Study site

    London, Ontario, N6A 4V2

  • Study site

    Mississauga, Ontario, L4W 1W9

  • Study site

    Montreal, Quebec, H3A 1A1

  • Study site

    Ottawa, Ontario, K1H 8L6

  • Study site

    Saskatoon, Saskatchewan, S7K 0M7

  • Study site

    Toronto, Ontario, M4N 3M5

  • Study site

    Toronto, Ontario, M5T 2S8

  • Study site

    Vancouver, British Columbia, V5Z 3N9

  • Study site

    Winnipeg, Manitoba, R3P 1A2

Other trials in Canada

United Kingdom7 sites

  • Study site

    Belfast, BT12 6BA

  • Study site

    Liverpool, L7 8XP

  • Study site

    London, EC1V 2PD

  • Study site

    London, SE5 9RS

  • Study site

    Plymouth, PL6 8DH

  • Study site

    Southampton, SO16 6YD

  • Study site

    Surrey Quays, GU17UJ

Other trials in United Kingdom

Brazil6 sites

  • Study site

    Goiânia, Goiás, 74210

  • Study site

    Minas Gerais, 30150-270

  • Study site

    Porto Alegre, Rio Grande do Sul, 90440

  • Study site

    São Paulo, 01525-001

  • Study site

    São Paulo, 04021-050

  • Study site

    São Paulo, 04023-062

Other trials in Brazil

Czechia6 sites

  • Study site

    Brno, 625 00

  • Study site

    Kralovice, 500 05

  • Study site

    Libeň, 401 13

  • Study site

    Olomouc, 775 20

  • Study site

    Prague, 10 100 34

  • Study site

    Prague, 6 169 02

Other trials in Czechia

Poland5 sites

  • Study site

    Bydgoszcz, 85-631

  • Study site

    Katowice, 43-300

  • Study site

    Lodz, 91 -134

  • Study site

    Warsaw, 02005

  • Study site

    Wroclaw, 50-556

Other trials in Poland

Austria4 sites

  • Study site

    Graz, 8036

  • Study site

    Innsbruck, 6020

  • Study site

    Linz, 4021

  • Study site

    Vienna, 1090

Other trials in Austria

Switzerland4 sites

  • Study site

    Basel, 4102

  • Study site

    Bern, 3010

  • Study site

    Lausanne, 1000

  • Study site

    Zurich, 8063

Other trials in Switzerland

Estonia3 sites

  • Study site

    Harju, 11412

  • Study site

    Tallinn, 10138

  • Study site

    Tartu, 51003

Other trials in Estonia

Slovakia3 sites

  • Study site

    Banská Bystrica, 975 17

  • Study site

    Bratislava, 826 06

  • Study site

    Trenčín, 91171

Other trials in Slovakia

Belgium2 sites

  • Study site

    Deurne, Antwerpen, 2100

  • Study site

    Leuven, Vlaams-Brabant, 3000

Other trials in Belgium

Latvia2 sites

  • Study site

    Riga, LV-1050

  • Study site

    Riga, LV-11002

Other trials in Latvia

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 NCT01944839
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 posted18 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
619 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01944839
Sponsor's protocol ID
OPH1002
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 115 sites in 13 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 115 sites in United States, Italy, Canada, United Kingdom, Brazil and 8 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 10 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 NCT01944839, 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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