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

Neovascular Age-related Macular Degeneration Clinical Trial

— ShORe  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04757610
• Other study ID #: OPT-302-1004
• Status: Recruiting
• Phase: Phase 3
• Start date: March 12, 2021
• Est. completion date: July 2026

Study information

• Verified date: March 2024
• Source: Opthea Limited
• Contact: Opthea Limited
• Phone: +61 3 9826 0399
• Email: info[@]opthea.com
• 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: 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
• 0.5 mg ranibizumab
intravitreal injection

Procedure:
• Sham
intravitreal injection

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Opthea Limited

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Bulgaria,  Canada,  Colombia,  Czechia,  Denmark,  France,  Germany,  Greece,  Hungary,  India,  Israel,  Italy,  Korea, Republic of,  Latvia,  Malaysia,  Poland,  Spain,  Thailand,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in Early Treatment Diabetic 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 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		Baseline to Week 52