OPT-302 With Aflibercept in Neovascular Age-related Macular Degeneration (nAMD)

Neovascular Age-related Macular Degeneration Clinical Trial

— COAST  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04757636
• Other study ID #: OPT-302-1005
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: March 12, 2021
• Est. completion date: July 2026

Study information

• Verified date: March 2024
• Source: Opthea Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A 2-year phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 990
• Est. completion date: July 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

Biological:
• 2.0 mg OPT-302
intravitreal injection
• 2.0 aflibercept
intravitreal injection

Procedure:
• Sham
intravitreal injection

Locations

Country	Name	City	State
Argentina	COAST Investigational Site	Ciudad Autonoma de Buenos Aire
Argentina	COAST Investigational Site	Ciudad Autonoma de Buenos Aire
Argentina	COAST Investigational Site	Ciudad Autonoma de Buenos Aire
Argentina	COAST Investigational Site	Mendoza
Argentina	COAST Investigational Site	Rosario	Santa Fe
Argentina	COAST Investigational Site	Rosario	Sante Fe
Australia	COAST Investigational Site	Adelaide	South Australia
Australia	COAST Investigational Site	East Melbourne	Victoria
Australia	COAST Investigational Site	Liverpool	New South Wales
Australia	COAST Investigational Site	Parramatta	New South Wales
Australia	COAST Investigational Site	Rowville	Victoria
Australia	COAST Investigational Site	Strathfield	New South Wales
Austria	COAST Investigational Site	Graz
Brazil	COAST Investigational Site	Belo Horizonte	Minas Gerais
Brazil	COAST Investigational Site	Porto Alegre	Rio Grande Do Sul
Brazil	COAST Investigational Site	São Paulo
Brazil	COAST Investigational Site	São Paulo
Brazil	COAST Investigational Site	São Paulo
Bulgaria	COAST Investigational Site	Sofia
Bulgaria	COAST Investigational Site	Stara Zagora
Canada	COAST Investigational Site	Brampton	Ontario
Canada	COAST Investigational Site	North York	Ontario
Canada	COAST Investigational Site	Ottawa	Ontario
Canada	COAST Investigational Site	Ottawa	Ontario
Colombia	COAST Investigational Site	Barranquilla
Colombia	COAST Investigational Site	Bogotá
Colombia	COAST Investigational Site	Bogotá	Cundinamarca
Colombia	COAST Investigational Site	Cali	VAlle Del Cauca
Colombia	COAST Investigational Site	Cali
Colombia	COAST Investigational Site	Medellín
Colombia	COAST Investigational Site	Medellín	Antioquia
Croatia	COAST Investigational Site	Osijek
Croatia	COAST Investigational Site	Osijek
Croatia	COAST Investigational Site	Split
Croatia	COAST Investigational Site	Zagreb
Czechia	COAST Investigational Site	Brno
Czechia	COAST Investigational Site	Hradec Králové	Cech Republic
Czechia	COAST Investigational Site	Praha
Czechia	COAST Investigational Site	Praha
Czechia	COAST Investigational Site	Praha 2
Czechia	COAST Investigational Site	Praha 4-Krc
Denmark	COAST Investigational Site	Roskilde
Estonia	COAST Investigational Site	Tallinn
Estonia	COAST Investigational Site	Tallinn
Estonia	COAST Investigational Site	Tallinn
France	COAST Investigational Site	Dijon	Cote-d'Or
France	COAST Investigational Site	Lyon	Rhone
France	COAST Investigational Site	Paris
France	COAST Investigational Site	Poitiers	Vienne
Germany	COAST Investigational Site	Berlin
Germany	COAST Investigational Site	Koeln	Nordrhein Westfalen
Germany	COAST Investigational Site	Mainz	Rheinland Pfalz
Germany	COAST Investigational Site	Tuebingen	Baden Wu
Greece	COAST Investigational Site	Athens
Greece	COAST Investigational Site	Heraklion
Greece	COAST Investigational Site	Larissa
Greece	COAST Investigational Site	Thessaloníki
Hungary	COAST Investigational Site	Budapest
Hungary	COAST Investigational Site	Budapest
Hungary	COAST Investigational Site	Budapest
Hungary	COAST Investigational Site	Budapest
Hungary	COAST Investigational Site	Budapest
Hungary	COAST Investigational Site	Debrecen
Hungary	COAST Investigational Site	Nyiregyhaza
Hungary	COAST Investigational Site	Pécs
Hungary	COAST Investigational Site	Pécs
Hungary	COAST Investigational Site	Zalaegerszeg
India	COAST Investigational Site	Bhubaneswar	Orissa
India	COAST Investigational Study	Hyderabad	Andhra Pradesh
India	COAST Investigational Site	Madurai	Tamil Nadu
India	COAST Investigational Site	Mysore	Karnataka
India	COAST Investigational Site	Nashik	Maharashtra
India	COAST Investigational Site	Ranchi	Jharkhand
Israel	COAST Investigational Study	Afula
Israel	COAST Investigational Site	Haifa
Israel	COAST Investigational Site	Haifa
Israel	COAST Investigational Site	Jerusalem
Israel	COAST Investigational Site	Jerusalem
Israel	COAST Investigational Site	Re?ovot
Israel	COAST Investigational Site	Tel Aviv
Italy	COAST Investigational Site	Ancona	Perugia
Italy	COAST Investigational Site	Firenze
Italy	COAST Investigational Site	Milan
Italy	COAST Investigational Site	Milano
Italy	COAST Investigational Study	Milano
Italy	COAST Investigational Site	Pisa
Italy	COAST Investigational Site	Roma
Italy	COAST Investigational Site	Rome
Italy	COAST Investigational Site	Rozzano
Korea, Republic of	COAST Investigational Site	Busan
Korea, Republic of	COAST Investigational Site	Seongnam-si	Gyeonggi-do
Korea, Republic of	COAST Investigational Site	Seoul
Korea, Republic of	COAST Investigational Site	Seoul
Korea, Republic of	COAST Investigational Site	Seoul
Korea, Republic of	COAST Investigational Site	Seoul
Korea, Republic of	COAST Investigational Site	Seoul
Korea, Republic of	COAST Investigational Site	Soeul
Korea, Republic of	COAST Investigational Site	Suwon	Gyeonggi-do
Latvia	COAST Investigational Site	Riga
Latvia	COAST Investigational Site	Riga
Lithuania	COAST Investigational Study	Kaunas
Lithuania	COAST Investigational Study	Klaipeda
Lithuania	COAST Investigational Site	Vilnius
Netherlands	COAST Investigational Site	Nijmegen
Netherlands	COAST Investigational Site	Rotterdam
Netherlands	COAST Investigational Site	Tilburg
Philippines	COAST Investigational Site	Makati
Philippines	COAST Investigational Site	Makati City
Philippines	COAST Investigational Site	Pasig City
Philippines	COAST Investigational Site	Quezon City
Philippines	COAST Investigational Site	Santo Tomas	Batangas
Poland	COAST Investigational Site	Bielsko-Biala
Poland	COAST Investigational Site	Bydgoszcz
Poland	COAST Investigational Site	Bydgoszcz
Poland	COAST Investigational Site	Bytom
Poland	COAST Investigational Site	Lódz
Poland	COAST Investigational Site	Lublin
Poland	COAST Investigational Site	Olsztyn
Poland	COAST Investigational Site	Poznan
Puerto Rico	COAST Investigational Site	Arecibo
Slovakia	COAST Investigational Site	Žilina
Slovakia	COAST Investigational Site	Bratislava
Slovakia	COAST Investigational Site	Trebišov
Slovakia	COAST Investigational Site	Trencín
Spain	COAST Investigational Site	Badalona	Barcelona
Spain	COAST Investigational Site	Barcelona
Spain	COAST Investigational Site	Barcelona
Spain	COAST Investigational Site	Barcelona
Spain	COAST Investigational Site	Madrid
Spain	COAST Investigational Site	Majadahonda	Madrid
Spain	COAST Investigational Site	Oviedo	Asturias
Spain	COAST Investigational Site	Valencia
Spain	COAST Investigational Site	Zaragoza
Spain	COAST Investigational Site	Zaragoza
Taiwan	COAST Investigational Site	Kaohsiung
Taiwan	COAST Investigational Site	Kaohsiung
Taiwan	COAST Investigational Site	Taichung
Taiwan	COAST Invesigational Site	Taipei
Taiwan	COAST Investigational Site	Taipei
Taiwan	COAST Investigational Site	Taoyuan City
United Kingdom	COAST Investigational Site	Frimley	Surrey
United Kingdom	COAST Investigational Site	Gorleston-on-Sea	Norfolk
United Kingdom	COAST Investigational Site	Leeds	West Yorkshire
United Kingdom	COAST Investigational Site	Liverpool	Merseyside
United Kingdom	COAST Investigational Site	London
United Kingdom	COAST Investigational Site	Manchester	Greater Manchester
United Kingdom	COAST Investigational Site	Plymouth	Devon
United Kingdom	COAST Investigational Site	Sunderland	Tyne And Wear
United Kingdom	COAST Investigational Site	Westcliff-on-Sea	Essex
United States	COAST Investigational Site	'Aiea	Hawaii
United States	COAST Investigational Site	Abilene	Texas
United States	COAST Investigational Site	Albuquerque	New Mexico
United States	COAST Investigational Site	Altamonte Springs	Florida
United States	COAST Investigational Site	Arcadia	California
United States	COAST Investigational Site	Asheville	North Carolina
United States	COAST Investigational Site	Austin	Texas
United States	COAST Investigational Site	Bellevue	Washington
United States	COAST Investigational Site	Boston	Massachusetts
United States	COAST Investigational Site	Boynton Beach	Florida
United States	COAST Investigational Site	Burleson	Texas
United States	COAST Investigational Site	Chicago	Illinois
United States	COAST Investigational Site	Cincinnati	Ohio
United States	COAST Investigational Site	Conroe	Texas
United States	COAST Investigational Site	Coral Springs	Florida
United States	COAST Investigational Site	Dallas	Texas
United States	COAST Investigational Site	Danbury	Connecticut
United States	COAST Investigational Site	Dayton	Ohio
United States	COAST Investigational Site	Edison	New Jersey
United States	COAST Investigational Site	Fairfax	Virginia
United States	COAST Investigational Site	Germantown	Tennessee
United States	COAST Investigational Site	Greenville	South Carolina
United States	COAST Investigational Site	Hagerstown	Maryland
United States	COAST Investigational Site	Huntington Beach	California
United States	COAST Investigational Site	Independence	Missouri
United States	COAST Investigational Site	Jackson	Mississippi
United States	COAST Investigational Site	Kingston	Pennsylvania
United States	COAST Investigational Site	Knoxville	Tennessee
United States	COAST Investigational Site	Lenexa	Kansas
United States	COAST Investigational Site	Marietta	Georgia
United States	COAST Investigational Site	Melbourne	Florida
United States	COAST	Morgantown	West Virginia
United States	COAST Investigational Site	New Albany	Indiana
United States	COAST Investigational Site	Oklahoma City	Oklahoma
United States	COAST Investigational Site	Orlando	Florida
United States	COAST Investigational Site	Owings Mills	Maryland
United States	COAST Investigational Site	Philadelphia	Pennsylvania
United States	COAST Investigational Site	Phoenix	Arizona
United States	COAST Investigational Site	Plano	Texas
United States	COAST Investigational Site	Plantation	Florida
United States	COAST Investigational Site	Prairie Village	Kansas
United States	COAST Investigational Site	Rapid City	South Dakota
United States	COAST Investigational Site	Redlands	California
United States	COAST Investigational Site	Round Rock	Texas
United States	COAST Investigational Site	Sacramento	California
United States	COAST Investigational Site	Saint Louis	Missouri
United States	COAST Investigational Site	Saint Petersburg	Florida
United States	COAST Investigational Site	Sarasota	Florida
United States	COAST Investigational site	Shirley	New York
United States	COAST Investigational Site	Spokane	Washington
United States	COAST Investigational Site	Springfield	Illinois
United States	COAST Investigational Site	Springfield	Oregon
United States	COAST Investigational Site	Stuart	Florida
United States	COAST Investigational Site	Urbana	Illinois
United States	COAST Investigational Site	West Columbia	South Carolina
United States	COAST Investigational Site	West Monroe	Louisiana
United States	COAST Investigational Site	Wilmington	North Carolina
United States	COAST Investigational Site	Winston-Salem	North Carolina
United States	COAST Investigational Site	Winter Haven	Florida
United States	COAST Investigational Site	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Opthea Limited

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Brazil,  Bulgaria,  Canada,  Colombia,  Croatia,  Czechia,  Denmark,  Estonia,  France,  Germany,  Greece,  Hungary,  India,  Israel,  Italy,  Korea, Republic of,  Latvia,  Lithuania,  Netherlands,  Philippines,  Poland,  Puerto Rico,  Slovakia,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in Early Treatment Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters		Baseline to Week 52
Secondary	Proportion of participants gaining 15 or more ETDRS BCVA letters		Baseline to Week 52
Secondary	Proportion of participants gaining 10 or more ETDRS BCVA letters		Baseline to Week 52
Secondary	Change in choroidal neovascularisation (CNV) area by fluorescein angiography (FA)		Baseline to Week 52
Secondary	Proportion of participants with absence of both sub-retinal fluid and intra-retinal cysts by SD-OCT		at Week 52