Clinical trial NCT01944839: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Age-Related Macular Degeneration
Keywords: Wet AMD
choroidal neovascularization
Fovista®
E10030
Lucentis®
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2013-09-18
Enrollment: 619
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Mean Change in Visual Acuity From Baseline to 12 Months
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Bakersfield
country: United States
state: California
city: Beverly Hills
country: United States
state: California
city: Los Angeles
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state: California
city: San Francisco
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state: California
city: Santa Barbara
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state: California
city: Colorado Springs
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state: Colorado
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state: Connecticut
city: New London
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state: Connecticut
city: Altamonte Springs
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city: Fort Myers
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state: Florida
city: Sarasota
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state: Florida
city: Tampa
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state: Kentucky
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state: Louisiana
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state: Maryland
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state: Michigan
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state: Minnesota
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state: Missouri
city: Las Vegas
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state: Nevada
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state: New Mexico
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state: Virginia
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state: Wisconsin
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country: Austria
city: Innsbruck
country: Austria
city: Linz
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city: Wien
country: Austria
city: Deurne
country: Belgium
state: Antwerpen
city: Leuven
country: Belgium
state: Vlaams-Brabant
city: Goiânia
country: Brazil
state: Goiás
city: Porto Alegre
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state: Rio Grande Do Sul
city: Minas Gerais
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city: Sao Paulo
country: Brazil
city: Sao Paulo
country: Brazil
city: Sao Paulo
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city: Calgary
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state: Alberta
city: Vancouver
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city: Winnipeg
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city: Kralovice
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city: Libeň
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city: Prague
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city: Praha
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city: Harju
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city: Tallinn
country: Estonia
city: Tartu
country: Estonia
city: Ancona
country: Italy
city: Bologna
country: Italy
city: Ferrara
country: Italy
city: Firenze
country: Italy
city: Milano
country: Italy
city: Milano
country: Italy
city: Milano
country: Italy
city: Padova
country: Italy
city: Roma
country: Italy
city: Roma
country: Italy
city: Torino
country: Italy
city: Udine
country: Italy
city: Riga
country: Latvia
city: Riga
country: Latvia
city: Bydgoszcz
country: Poland
city: Katowice
country: Poland
city: Lodz
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Banska Bystrica
country: Slovakia
city: Bratislava
country: Slovakia
city: Trencin
country: Slovakia
city: Basel
country: Switzerland
city: Bern
country: Switzerland
city: Lausanne
country: Switzerland
city: Zurich
country: Switzerland
city: Belfast
country: United Kingdom
city: Liverpool
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Plymouth
country: United Kingdom
city: Southampton
country: United Kingdom
city: Surrey Quays
country: United Kingdom
Study officials:
References:
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.