Clinical trial NCT04757610: OPT-302 With Ranibizumab 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 Ranibizumab, Compared With Ranibizumab Alone, in Participants With nAMD
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Neovascular Age-related Macular Degeneration
Lead sponsor: Opthea Limited
Sponsor class: INDUSTRY
First posted: 2021-02-17
Enrollment: 986
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 may apply

Primary outcomes:
measure: Mean change in Early Treatment Diabetic 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 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: Baseline to Week 52
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: ShORe Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: ShORe Investigational Site
state: Arizona
city: Tucson
country: United States
facility: ShORe Investigational Site
state: Arizona
city: Bakersfield
country: United States
facility: ShORe Investigational Site
state: California
city: Campbell
country: United States
facility: ShORe Investigational Site
state: California
city: Encino
country: United States
facility: ShORe Investigational Site
state: California
city: Fullerton
country: United States
facility: ShORe Investigational Site
state: California
city: Glendale
country: United States
facility: ShORe Investigational Site
state: California
city: Huntington Beach
country: United States
facility: ShORe Investigational Site
state: California
city: Laguna Hills
country: United States
facility: ShORe Investigational Site
state: California
city: Long Beach
country: United States
facility: ShORe Investigational Site
state: California
city: Los Angeles
country: United States
facility: ShORe Investigational Site
state: California
city: Mountain View
country: United States
facility: ShORe Investigational Site
state: California
city: Palm Desert
country: United States
facility: ShORe Investigational Site
state: California
city: Pasadena
country: United States
facility: ShORe Investigational site
state: California
city: Poway
country: United States
facility: ShORe Investiagtional Site
state: California
city: Redlands
country: United States
facility: ShORe Investigational Site
state: California
city: Sacramento
country: United States
facility: ShORe Investigational Site
state: California
city: Santa Ana
country: United States
facility: ShORe Investigational Site
state: California
city: Torrance
country: United States
facility: ShORe Investigational Site
state: California
city: Colorado Springs
country: United States
facility: ShORe Investigational Site
state: Colorado
city: Denver
country: United States
facility: ShORe Investigational Site
state: Colorado
city: Lakewood
country: United States
facility: ShORe Investigational Site
state: Colorado
city: Longmont
country: United States
facility: ShORe Investigational Site
state: Colorado
city: Clearwater
country: United States
facility: ShORe Investigational Site
state: Florida
city: Fort Lauderdale
country: United States
facility: ShORe Investigational Site
state: Florida
city: Fort Myers
country: United States
facility: ShORe Investigational Site
state: Florida
city: Gainesville
country: United States
facility: ShORe Investigational Site
state: Florida
city: Lakeland
country: United States
facility: ShORe Investigational Site
state: Florida
city: Pensacola
country: United States
facility: ShORe Investigational Site
state: Florida
city: Pinellas Park
country: United States
facility: ShORe Investigational Site
state: Florida
city: Temple Terrace
country: United States
facility: ShORe Investigational Site
state: Florida
city: Augusta
country: United States
facility: ShORe Investigational Site
state: Georgia
city: Sandy Springs
country: United States
facility: ShORe Investigational Site
state: Georgia
city: Lemont
country: United States
facility: ShORe Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: ShORe Investigational Site
state: Indiana
city: Baltimore
country: United States
facility: ShORe Investigational Site
state: Maryland
city: Baltimore
country: United States
facility: ShORe Investigational Site
state: Maryland
city: Hagerstown
country: United States
facility: ShORe Investigational Site
state: Maryland
city: Towson
country: United States
facility: ShORe Investigational Site
state: Maryland
city: Springfield
country: United States
facility: ShORe Investigational Site
state: Massachusetts
city: Minneapolis
country: United States
facility: ShORe Investigational Site
state: Minnesota
city: Saint Louis
country: United States
facility: ShORe Investigational Site
state: Missouri
city: Reno
country: United States
facility: ShORe Investigational Site
state: Nevada
city: Bloomfield
country: United States
facility: ShORe Investigational Site
state: New Jersey
city: Toms River
country: United States
facility: ShORe Investigational Site
state: New Jersey
city: Hauppauge
country: United States
facility: ShORe Investigational Site
state: New York
city: Liverpool
country: United States
facility: ShORe Investigational Site
state: New York
city: Wake Forest
country: United States
facility: ShORe Investigational Site
state: North Carolina
city: Fargo
country: United States
facility: ShORe Investigational Site
state: North Dakota
city: Edmond
country: United States
facility: ShORe Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: ShORe Investigational Site
state: Oklahoma
city: Eugene
country: United States
facility: ShORe Investigational Site
state: Oregon
city: Portland
country: United States
facility: ShORe Investigational Site
state: Oregon
city: Portland
country: United States
facility: ShORe Investigational Site
state: Oregon
city: Salem
country: United States
facility: ShORe Investigational Site
state: Oregon
city: Erie
country: United States
facility: ShORe Investigational Site
state: Pennsylvania
city: Beaufort
country: United States
facility: ShORe Investigational Site
state: South Carolina
city: Ladson
country: United States
facility: ShORe Investigational Site
state: South Carolina
city: Nashville
country: United States
facility: ShORe Investigational Site
state: Tennessee
city: Arlington
country: United States
facility: ShORe Investigational Site
state: Texas
city: Austin
country: United States
facility: ShORe Investigational Site
state: Texas
city: Austin
country: United States
facility: ShORe Investigational Site
state: Texas
city: Bellaire
country: United States
facility: ShORe Investigational Site
state: Texas
city: Dallas
country: United States
facility: ShORe Investigational Site
state: Texas
city: Houston
country: United States
facility: ShORe Investigational Site
state: Texas
city: Katy
country: United States
facility: ShORe Investigational Site
state: Texas
city: McAllen
country: United States
facility: ShORe Investigational Site
state: Texas
city: San Antonio
country: United States
facility: ShORe Investigational Site
state: Texas
city: San Antonio
country: United States
facility: ShORe Investigational Site
state: Texas
city: San Antonio
country: United States
facility: ShORe Investigational Site
state: Texas
city: Tyler
country: United States
facility: ShORe Investigational Site
state: Texas
city: Willow Park
country: United States
facility: ShORe Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: ShORe Investigational Site
state: Utah
city: Charlottesville
country: United States
facility: ShORe Investigational Site
state: Virginia
city: Lynchburg
country: United States
facility: ShORe Investigational Site
state: Virginia
city: Capital federal
country: Argentina
facility: ShORe Investigational Site
state: Ciudad Autonoma Buenos Aires
city: Rosario
country: Argentina
facility: ShORe Investigational Site
state: Santa Fe
city: Rosario
country: Argentina
facility: ShORe Investigational Site
state: Sante Fe
city: Buenos Aires
country: Argentina
facility: ShORe Investigational Site
city: Buenos Aires
country: Argentina
facility: ShORe Investigational Site
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: ShORe Investigational Site
city: Córdoba
country: Argentina
facility: ShORe Investigational Site
city: Hurstville
country: Australia
facility: ShORe Investigational Site
state: New South Wales
city: Melbourne
country: Australia
facility: ShORe Investigational Site
state: Victoria
city: Vitória
country: Brazil
facility: ShORe Investigational Site
state: Cordoba
city: Goiânia
country: Brazil
facility: ShORe Investigational Site
state: Goias
city: Faxinal do Soturno
country: Brazil
facility: ShORe Investigational Site
state: Rio Grande Do Sul
city: Blumenau
country: Brazil
facility: ShORe Investigational site
state: Santa Catarina
city: Santo André
country: Brazil
facility: ShORe Investigational Site
state: Sao Paulo
city: São Paulo
country: Brazil
facility: ShORe Investigational Site
city: São Paulo
country: Brazil
facility: ShORe Investigational Site
city: Sofia
country: Bulgaria
facility: ShORe Investigational Site
city: Calgary
country: Canada
facility: ShORe Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: ShORe Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: ShORe Investigational Site
state: Alberta
city: Mississauga
country: Canada
facility: ShORe Investigational Site
state: Ontario
city: Medellín
country: Colombia
facility: ShORe Investigational Site
city: Pardubice
country: Czechia
facility: ShORe Investigational Site
city: Praha
country: Czechia
facility: ShORe Investigational Site
city: Praha
country: Czechia
facility: ShORe Investigational Site
city: Sokolov
country: Czechia
facility: ShORe Investigational Site
city: Aarhus
country: Denmark
facility: ShORe Investigational Site
city: Glostrup
country: Denmark
facility: ShORe Investigational Site
city: Sønderborg
country: Denmark
facility: ShORe Investigational Site
city: Nice
country: France
facility: ShORe Investigational Site
state: Alpes-Maritimes
city: Strasbourg
country: France
facility: ShORe Investigational Site
state: Bas Rhin
city: Écully
country: France
facility: ShORe Investigational Site
state: Rhone
city: Créteil
country: France
facility: ShORe Investigational Site
state: Val De Marr
city: Heidelberg
country: Germany
facility: ShORe Investigational Site
state: Baden Wuerttemberg
city: Ulm
country: Germany
facility: ShORe Investigational Site
state: Baden Wuerttermberg
city: Goettigen
country: Germany
facility: ShORe Investigational Site
state: Niedersachsen
city: Bonn
country: Germany
facility: ShORe Investigational Site
state: Nordrhein Westfalen
city: Münster
country: Germany
facility: ShORe Investigational Site
state: Nordrhein Westfalen
city: Düsseldorf
country: Germany
facility: ShORe Investigational Site
state: Nordrhein
city: Münster
country: Germany
facility: ShORe Investigational Site
state: Nordrhein
city: Hamburg
country: Germany
facility: ShORe Investigational Site
city: Athens
country: Greece
facility: ShORe Investigational Site
city: Ioánnina
country: Greece
facility: ShORe Investigational Site
city: Patra
country: Greece
facility: ShORe Investigational Site
city: Budapest
country: Hungary
facility: ShORe Investigational Site
city: Miskolc
country: Hungary
facility: ShORe Investigational Site
city: Szombathely
country: Hungary
facility: ShORe Investigational Site
city: Ahmedabad
country: India
facility: ShORe Investigational Site
state: Gujarat
city: Sūrat
country: India
facility: ShORe Investigational Site
state: Gujarat
city: Bangalore
country: India
facility: ShORe Investigational Site
state: Karnataka
city: Bangalore
country: India
facility: ShORe Investigational Site
state: Karnataka
city: Pune
country: India
facility: ShORe Investigational Site
state: Maharashtra
city: Chandigarh
country: India
facility: ShORe Investigational Site
state: Punjab
city: Coimbatore
country: India
facility: ShORe Investigational Site
state: Tamilnadu
city: Lucknow
country: India
facility: ShORe Investigational Site
state: Uttar Pradesh
city: Kolkata
country: India
facility: ShORe Investigational Site
state: West Bengal
city: Mysuru
country: India
facility: ShORe Investigational Site
city: Be'er Sheva
country: Israel
facility: ShORe Investigational Site
city: Haifa
country: Israel
facility: ShORe Investigational Site
city: Kfar-Sava
country: Israel
facility: ShORe Investigational Site
city: Petach Tikva
country: Israel
facility: ShORe Investigational Site
city: Rishon LeZion
country: Israel
facility: ShORe Investigational Site
city: Catanzaro
country: Italy
facility: ShORe Investigational Site
state: Reggio Calabria
city: Bologna
country: Italy
facility: ShORe Investigational Site
city: Chieti
country: Italy
facility: ShORe Investigational Site
city: Genova
country: Italy
facility: ShORe Investiagational Site
city: Roma
country: Italy
facility: ShORe Investigational Site
city: Siena
country: Italy
facility: ShORe Investigational Site
city: Udine
country: Italy
facility: ShORe Investigational Site
city: Seongnam
country: Korea, Republic of
facility: ShORe Investigational Site
state: Gyeonggi-do
city: Daegu
country: Korea, Republic of
facility: ShORe Investigational Site
state: Gyeongsangbuk-do
city: Busan
country: Korea, Republic of
facility: ShORe Investigational Site
city: Busan
country: Korea, Republic of
facility: ShORe Investigational Site
city: Gwangju
country: Korea, Republic of
facility: ShORe Investigational Site
city: Seoul
country: Korea, Republic of
facility: ShORe Investigational Site
city: Seoul
country: Korea, Republic of
facility: ShORe Investigational Site
city: Seoul
country: Korea, Republic of
facility: ShORe Investigational Site
city: Seoul
country: Korea, Republic of
facility: ShORe Investigational Site
city: Seoul
country: Korea, Republic of
facility: ShORe Investigational Site
city: Seoul
country: Korea, Republic of
facility: ShORe Investigational Site
city: Riga
country: Latvia
facility: ShORe Investigational Site
city: Batu Caves
country: Malaysia
facility: ShORe Investigational Site
state: Selangor
city: Shah Alam
country: Malaysia
facility: ShORe Investigational Site
state: Selangor
city: Kuala Lumpur
country: Malaysia
facility: ShORe Investigational Site
city: Gdańsk
country: Poland
facility: ShORe Investigational Site
city: Kraków
country: Poland
facility: ShORe Investigational Site
city: Olsztyn
country: Poland
facility: ShORe Investigational Site
city: Szczecin
country: Poland
facility: ShORe Investigational Site
city: Tarnowskie Góry
country: Poland
facility: ShORe Investigational Site
city: Warsaw
country: Poland
facility: ShORe Investigational Site
city: Wroclaw
country: Poland
facility: ShORe Investigational Site
city: Sant Cugat Del Vallès
country: Spain
facility: ShORe Investigational Site
state: Barcelona
city: Alcala de Henares
country: Spain
facility: ShORe Investigational Site
state: Madrid
city: Pamplona
country: Spain
facility: ShORe Investigational Site
state: Navarra
city: Burjassot
country: Spain
facility: ShORe Investigational Site
state: Valencia
city: Barcelona
country: Spain
facility: ShORe Investigational Site
city: Barcelona
country: Spain
facility: ShORe Investigational Site
city: Burgos
country: Spain
facility: ShORe Investigational Site
city: Córdoba
country: Spain
facility: ShORe Investigational Site
city: Madrid
country: Spain
facility: ShORe Investigational Site
city: Madrid
country: Spain
facility: ShORe Investigational Site
city: Valencia
country: Spain
facility: ShORe Investigational Site
city: Pathum Wan
country: Thailand
facility: ShORe Investigational Site
state: Bangkok
city: Chiang Mai
country: Thailand
facility: ShORe Investigational Site
city: Khon Kaen
country: Thailand
facility: ShORe Investigational Site
city: Pathum Thani
country: Thailand
facility: ShORe Investigational Site
city: Kiev
country: Ukraine
facility: ShORe Investigational Site
city: Crewe
country: United Kingdom
facility: ShORe Investigational Site
state: Cheshire
city: Southampton
country: United Kingdom
facility: ShORe Investigational Site
state: Hampshire
city: Leicester
country: United Kingdom
facility: ShORe Investigational Site
state: Leicestershire
city: Bristol
country: United Kingdom
facility: ShORe Investigational Site
state: Somerset
city: Guildford
country: United Kingdom
facility: ShORe Investigational Site
state: Surrey
city: Wolverhampton
country: United Kingdom
facility: ShORe Investigational Site
state: West Midlands
city: London
country: United Kingdom
facility: ShORe Investigational Site
city: London
country: United Kingdom
facility: ShORe Investigational Site
Study officials:
References: