Clinical trial NCT04757636: OPT-302 With Aflibercept in Neovascular Age-related Macular Degeneration (nAMD)
Official title: A Phase 3, Multicentre, Double-masked, Randomised Study to Evaluate the Efficacy and Safety of Intravitreal OPT-302 in Combination With Aflibercept, Compared With Aflibercept Alone, in Participants With nAMD
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Neovascular Age-related Macular Degeneration
Keywords: nAMD
wet AMD
Wet Macular Degeneration
Macular Degeneration
Eye Diseases
Retinal Diseases
Retinal Degeneration
Lead sponsor: Opthea Limited
Sponsor class: INDUSTRY
First posted: 2021-02-17
Enrollment: 998
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: A 2-year phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.


Eligibility criteria: Inclusion Criteria:

* Active subfoveal CNV lesion or juxtafoveal CNV lesion with foveal involvement that is secondary to AMD in the Study Eye.
* An ETDRS BCVA score between 60 and 25 (inclusive) letters in the Study Eye.

Main Exclusion Criteria:

* Any previous treatment for neovascular AMD.
* Clinically significant ocular disorders (other than neovascular AMD), which may interfere with assessment of BCVA, assessment of safety, or fundus imaging.
* Any current (or history of a) social, psychological, or medical condition that precludes enrolment into the study.

  * Additional inclusion/exclusion criteria apply.

Primary outcomes:
measure: Mean change in Early Treatment Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters
timeFrame: Baseline to Week 52
Secondary outcomes:
measure: Proportion of participants gaining 15 or more ETDRS BCVA letters
timeFrame: Baseline to Week 52
measure: Proportion of participants gaining 10 or more ETDRS BCVA letters
timeFrame: Baseline to Week 52
measure: Change in choroidal neovascularisation (CNV) area by fluorescein angiography (FA)
timeFrame: Baseline to Week 52
measure: Proportion of participants with absence of both sub-retinal fluid and intra-retinal cysts by SD-OCT
timeFrame: at Week 52
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: COAST Investigational Site
state: Arizona
city: Arcadia
country: United States
facility: COAST Investigational Site
state: California
city: Huntington Beach
country: United States
facility: COAST Investigational Site
state: California
city: Redlands
country: United States
facility: COAST Investigational Site
state: California
city: Sacramento
country: United States
facility: COAST Investigational Site
state: California
city: Danbury
country: United States
facility: COAST Investigational Site
state: Connecticut
city: Altamonte Springs
country: United States
facility: COAST Investigational Site
state: Florida
city: Boynton Beach
country: United States
facility: COAST Investigational Site
state: Florida
city: Coral Springs
country: United States
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state: Florida
city: Melbourne
country: United States
facility: COAST Investigational Site
state: Florida
city: Orlando
country: United States
facility: COAST Investigational Site
state: Florida
city: Plantation
country: United States
facility: COAST Investigational Site
state: Florida
city: Saint Petersburg
country: United States
facility: COAST Investigational Site
state: Florida
city: Sarasota
country: United States
facility: COAST Investigational Site
state: Florida
city: Stuart
country: United States
facility: COAST Investigational Site
state: Florida
city: Winter Haven
country: United States
facility: COAST Investigational Site
state: Florida
city: Marietta
country: United States
facility: COAST Investigational Site
state: Georgia
city: 'Aiea
country: United States
facility: COAST Investigational Site
state: Hawaii
city: Chicago
country: United States
facility: COAST Investigational Site
state: Illinois
city: Springfield
country: United States
facility: COAST Investigational Site
state: Illinois
city: Urbana
country: United States
facility: COAST Investigational Site
state: Illinois
city: New Albany
country: United States
facility: COAST Investigational Site
state: Indiana
city: Lenexa
country: United States
facility: COAST Investigational Site
state: Kansas
city: Prairie Village
country: United States
facility: COAST Investigational Site
state: Kansas
city: West Monroe
country: United States
facility: COAST Investigational Site
state: Louisiana
city: Hagerstown
country: United States
facility: COAST Investigational Site
state: Maryland
city: Owings Mills
country: United States
facility: COAST Investigational Site
state: Maryland
city: Boston
country: United States
facility: COAST Investigational Site
state: Massachusetts
city: Worcester
country: United States
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state: Massachusetts
city: Jackson
country: United States
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state: Mississippi
city: Independence
country: United States
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state: Missouri
city: Saint Louis
country: United States
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state: Missouri
city: Edison
country: United States
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state: New Jersey
city: Albuquerque
country: United States
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state: New Mexico
city: Shirley
country: United States
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state: New York
city: Asheville
country: United States
facility: COAST Investigational Site
state: North Carolina
city: Wilmington
country: United States
facility: COAST Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: COAST Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: COAST Investigational Site
state: Ohio
city: Dayton
country: United States
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state: Ohio
city: Oklahoma City
country: United States
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state: Oklahoma
city: Springfield
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state: Oregon
city: Kingston
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state: Pennsylvania
city: Philadelphia
country: United States
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state: Pennsylvania
city: Greenville
country: United States
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state: South Carolina
city: West Columbia
country: United States
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state: South Carolina
city: Rapid City
country: United States
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state: South Dakota
city: Germantown
country: United States
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state: Tennessee
city: Knoxville
country: United States
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state: Tennessee
city: Abilene
country: United States
facility: COAST Investigational Site
state: Texas
city: Austin
country: United States
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state: Texas
city: Burleson
country: United States
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state: Texas
city: Conroe
country: United States
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state: Texas
city: Dallas
country: United States
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state: Texas
city: Plano
country: United States
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state: Texas
city: Round Rock
country: United States
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state: Texas
city: Fairfax
country: United States
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state: Virginia
city: Bellevue
country: United States
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state: Washington
city: Spokane
country: United States
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state: Washington
city: Morgantown
country: United States
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state: West Virginia
city: Rosario
country: Argentina
facility: COAST Investigational Site
state: Santa Fe
city: Rosario
country: Argentina
facility: COAST Investigational Site
state: Sante Fe
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: COAST Investigational Site
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: COAST Investigational Site
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: COAST Investigational Site
city: Mendoza
country: Argentina
facility: COAST Investigational Site
city: Liverpool
country: Australia
facility: COAST Investigational Site
state: New South Wales
city: Parramatta
country: Australia
facility: COAST Investigational Site
state: New South Wales
city: Strathfield
country: Australia
facility: COAST Investigational Site
state: New South Wales
city: Adelaide
country: Australia
facility: COAST Investigational Site
state: South Australia
city: East Melbourne
country: Australia
facility: COAST Investigational Site
state: Victoria
city: Rowville
country: Australia
facility: COAST Investigational Site
state: Victoria
city: Graz
country: Austria
facility: COAST Investigational Site
city: Belo Horizonte
country: Brazil
facility: COAST Investigational Site
state: Minas Gerais
city: Porto Alegre
country: Brazil
facility: COAST Investigational Site
state: Rio Grande Do Sul
city: São Paulo
country: Brazil
facility: COAST Investigational Site
city: São Paulo
country: Brazil
facility: COAST Investigational Site
city: São Paulo
country: Brazil
facility: COAST Investigational Site
city: Sofia
country: Bulgaria
facility: COAST Investigational Site
city: Stara Zagora
country: Bulgaria
facility: COAST Investigational Site
city: Brampton
country: Canada
facility: COAST Investigational Site
state: Ontario
city: North York
country: Canada
facility: COAST Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: COAST Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: COAST Investigational Site
state: Ontario
city: Medellín
country: Colombia
facility: COAST Investigational Site
state: Antioquia
city: Bogotá
country: Colombia
facility: COAST Investigational Site
state: Cundinamarca
city: Cali
country: Colombia
facility: COAST Investigational Site
state: VAlle Del Cauca
city: Barranquilla
country: Colombia
facility: COAST Investigational Site
city: Bogotá
country: Colombia
facility: COAST Investigational Site
city: Cali
country: Colombia
facility: COAST Investigational Site
city: Medellín
country: Colombia
facility: COAST Investigational Site
city: Osijek
country: Croatia
facility: COAST Investigational Site
city: Osijek
country: Croatia
facility: COAST Investigational Site
city: Split
country: Croatia
facility: COAST Investigational Site
city: Zagreb
country: Croatia
facility: COAST Investigational Site
city: Hradec Králové
country: Czechia
facility: COAST Investigational Site
state: Cech Republic
city: Brno
country: Czechia
facility: COAST Investigational Site
city: Praha 2
country: Czechia
facility: COAST Investigational Site
city: Praha 4-Krc
country: Czechia
facility: COAST Investigational Site
city: Praha
country: Czechia
facility: COAST Investigational Site
city: Praha
country: Czechia
facility: COAST Investigational Site
city: Roskilde
country: Denmark
facility: COAST Investigational Site
city: Tallinn
country: Estonia
facility: COAST Investigational Site
city: Tallinn
country: Estonia
facility: COAST Investigational Site
city: Tallinn
country: Estonia
facility: COAST Investigational Site
city: Lyon
country: France
facility: COAST Investigational Site
state: Rhone
city: Poitiers
country: France
facility: COAST Investigational Site
state: Vienne
city: Dijon
country: France
facility: COAST Investigational Site
city: Paris
country: France
facility: COAST Investigational Site
city: Tuebingen
country: Germany
facility: COAST Investigational Site
state: Baden Wu
city: Koeln
country: Germany
facility: COAST Investigational Site
state: Nordrhein Westfalen
city: Mainz
country: Germany
facility: COAST Investigational Site
state: Rheinland Pfalz
city: Berlin
country: Germany
facility: COAST Investigational Site
city: Athens
country: Greece
facility: COAST Investigational Site
city: Heraklion
country: Greece
facility: COAST Investigational Site
city: Larissa
country: Greece
facility: COAST Investigational Site
city: Thessaloníki
country: Greece
facility: COAST Investigational Site
city: Budapest
country: Hungary
facility: COAST Investigational Site
city: Budapest
country: Hungary
facility: COAST Investigational Site
city: Budapest
country: Hungary
facility: COAST Investigational Site
city: Budapest
country: Hungary
facility: COAST Investigational Site
city: Budapest
country: Hungary
facility: COAST Investigational Site
city: Debrecen
country: Hungary
facility: COAST Investigational Site
city: Nyiregyhaza
country: Hungary
facility: COAST Investigational Site
city: Pécs
country: Hungary
facility: COAST Investigational Site
city: Pécs
country: Hungary
facility: COAST Investigational Site
city: Zalaegerszeg
country: Hungary
facility: COAST Investigational Site
city: Hyderabad
country: India
facility: COAST Investigational Site
state: Andhra Pradesh
city: Ranchi
country: India
facility: COAST Investigational Site
state: Jharkhand
city: Mysore
country: India
facility: COAST Investigational Site
state: Karnataka
city: Nashik
country: India
facility: COAST Investigational Site
state: Maharashtra
city: Bhubaneswar
country: India
facility: COAST Investigational Site
state: Orissa
city: Madurai
country: India
facility: COAST Investigational Site
state: Tamil Nadu
city: Afula
country: Israel
facility: COAST Investigational Site
city: Haifa
country: Israel
facility: COAST Investigational Site
city: Haifa
country: Israel
facility: COAST Investigational Site
city: Jerusalem
country: Israel
facility: COAST Investigational Site
city: Jerusalem
country: Israel
facility: COAST Investigational Site
city: Reẖovot
country: Israel
facility: COAST Investigational Site
city: Tel Aviv
country: Israel
facility: COAST Investigational Site
city: Ancona
country: Italy
facility: COAST Investigational Site
state: Perugia
city: Firenze
country: Italy
facility: COAST Investigational Site
city: Milano
country: Italy
facility: COAST Investigational Site
city: Milano
country: Italy
facility: COAST Investigational Site
city: Milan
country: Italy
facility: COAST Investigational Site
city: Pisa
country: Italy
facility: COAST Investigational Site
city: Roma
country: Italy
facility: COAST Investigational Site
city: Rome
country: Italy
facility: COAST Investigational Site
city: Rozzano
country: Italy
facility: COAST Investigational Site
city: Seongnam-si
country: Korea, Republic of
facility: COAST Investigational Site
state: Gyeonggi-do
city: Suwon
country: Korea, Republic of
facility: COAST Investigational Site
state: Gyeonggi-do
city: Busan
country: Korea, Republic of
facility: COAST Investigational Site
city: Seoul
country: Korea, Republic of
facility: COAST Investigational Site
city: Seoul
country: Korea, Republic of
facility: COAST Investigational Site
city: Seoul
country: Korea, Republic of
facility: COAST Investigational Site
city: Seoul
country: Korea, Republic of
facility: COAST Investigational Site
city: Seoul
country: Korea, Republic of
facility: COAST Investigational Site
city: Soeul
country: Korea, Republic of
facility: COAST Investigational Site
city: Riga
country: Latvia
facility: COAST Investigational Site
city: Riga
country: Latvia
facility: COAST Investigational Site
city: Kaunas
country: Lithuania
facility: COAST Investigational Site
city: Klaipėda
country: Lithuania
facility: COAST Investigational Site
city: Vilnius
country: Lithuania
facility: COAST Investigational Site
city: Nijmegen
country: Netherlands
facility: COAST Investigational Site
city: Rotterdam
country: Netherlands
facility: COAST Investigational Site
city: Tilburg
country: Netherlands
facility: COAST Investigational Site
city: Santo Tomas
country: Philippines
facility: COAST Investigational Site
state: Batangas
city: Makati City
country: Philippines
facility: COAST Investigational Site
city: Makati
country: Philippines
facility: COAST Investigational Site
city: Pasig City
country: Philippines
facility: COAST Investigational Site
city: Quezon City
country: Philippines
facility: COAST Investigational Site
city: Bielsko-Biala
country: Poland
facility: COAST Investigational Site
city: Bydgoszcz
country: Poland
facility: COAST Investigational Site
city: Bydgoszcz
country: Poland
facility: COAST Investigational Site
city: Bytom
country: Poland
facility: COAST Investigational Site
city: Lublin
country: Poland
facility: COAST Investigational Site
city: Olsztyn
country: Poland
facility: COAST Investigational Site
city: Poznań
country: Poland
facility: COAST Investigational Site
city: Łódź
country: Poland
facility: COAST Investigational Site
city: Arecibo
country: Puerto Rico
facility: COAST Investigational Site
city: Bratislava
country: Slovakia
facility: COAST Investigational Site
city: Trebišov
country: Slovakia
facility: COAST Investigational Site
city: Trenčín
country: Slovakia
facility: COAST Investigational Site
city: Žilina
country: Slovakia
facility: COAST Investigational Site
city: Oviedo
country: Spain
facility: COAST Investigational Site
state: Asturias
city: Badalona
country: Spain
facility: COAST Investigational Site
state: Barcelona
city: Majadahonda
country: Spain
facility: COAST Investigational Site
state: Madrid
city: Barcelona
country: Spain
facility: COAST Investigational Site
city: Barcelona
country: Spain
facility: COAST Investigational Site
city: Barcelona
country: Spain
facility: COAST Investigational Site
city: Madrid
country: Spain
facility: COAST Investigational Site
city: Valencia
country: Spain
facility: COAST Investigational Site
city: Zaragoza
country: Spain
facility: COAST Investigational Site
city: Zaragoza
country: Spain
facility: COAST Investigational Site
city: Kaohsiung
country: Taiwan
facility: COAST Investigational Site
city: Kaohsiung
country: Taiwan
facility: COAST Investigational Site
city: Taichung
country: Taiwan
facility: COAST Investigational Site
city: Taipei
country: Taiwan
facility: COAST Investigational Site
city: Taipei
country: Taiwan
facility: COAST Investigational Site
city: Taoyuan City
country: Taiwan
facility: COAST Investigational Site
city: Plymouth
country: United Kingdom
facility: COAST Investigational Site
state: Devon
city: Westcliff-on-Sea
country: United Kingdom
facility: COAST Investigational Site
state: Essex
city: Manchester
country: United Kingdom
facility: COAST Investigational Site
state: Greater Manchester
city: Liverpool
country: United Kingdom
facility: COAST Investigational Site
state: Merseyside
city: Gorleston-on-Sea
country: United Kingdom
facility: COAST Investigational Site
state: Norfolk
city: Frimley
country: United Kingdom
facility: COAST Investigational Site
state: Surrey
city: Sunderland
country: United Kingdom
facility: COAST Investigational Site
state: Tyne And Wear
city: Leeds
country: United Kingdom
facility: COAST Investigational Site
state: West Yorkshire
city: London
country: United Kingdom
facility: COAST Investigational Site
Study officials:
References: