Trial Review

Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04757636




Registration number
NCT04757636
Ethics application status
Date submitted
12/02/2021
Date registered
17/02/2021
Date last updated
28/03/2024

Titles & IDs
Public title
OPT-302 With Aflibercept in Neovascular Age-related Macular Degeneration (nAMD)
Scientific 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
Secondary ID [1] 0 0
OPT-302-1005
Universal Trial Number (UTN)
Trial acronym
COAST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neovascular Age-related Macular Degeneration 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - 2.0 mg OPT-302
Treatment: Other - 2.0 aflibercept
Treatment: Surgery - Sham

Experimental: 2.0 mg aflibercept with Standard Dosing 2.0 mg OPT-302 - 2.0 mg aflibercept intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals.

2.0 mg OPT-302 intravitreal injection administered at 4-weekly intervals.

Experimental: 2.0 mg aflibercept with Extended Dosing 2.0 mg OPT-302 - 2.0 mg aflibercept intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals.

2.0 mg OPT-302 intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals, with sham intravitreal injection administered at visits when OPT-302 is not.

Sham comparator: 2.0 mg aflibercept with sham - 2.0 mg aflibercept intravitreal injection administered at 4-weekly intervals for three treatments, and then at 8-weekly intervals.

Sham intravitreal injection administered at 4-weekly intervals.


Treatment: Other: 2.0 mg OPT-302
intravitreal injection

Treatment: Other: 2.0 aflibercept
intravitreal injection

Treatment: Surgery: Sham
intravitreal injection
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean change in Early Treatment Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters
Timepoint [1] 0 0
Baseline to Week 52
Secondary outcome [1] 0 0
Proportion of participants gaining 15 or more ETDRS BCVA letters
Timepoint [1] 0 0
Baseline to Week 52
Secondary outcome [2] 0 0
Proportion of participants gaining 10 or more ETDRS BCVA letters
Timepoint [2] 0 0
Baseline to Week 52
Secondary outcome [3] 0 0
Change in choroidal neovascularisation (CNV) area by fluorescein angiography (FA)
Timepoint [3] 0 0
Baseline to Week 52
Secondary outcome [4] 0 0
Proportion of participants with absence of both sub-retinal fluid and intra-retinal cysts by SD-OCT
Timepoint [4] 0 0
at Week 52

Eligibility
Key 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
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/03/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2026
Actual
Sample size
Target
990
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
COAST Investigational Site - Liverpool
Recruitment hospital [2] 0 0
COAST Investigational Site - Parramatta
Recruitment hospital [3] 0 0
COAST Investigational Site - Strathfield
Recruitment hospital [4] 0 0
COAST Investigational Site - Adelaide
Recruitment hospital [5] 0 0
COAST Investigational Site - East Melbourne
Recruitment hospital [6] 0 0
COAST Investigational Site - Rowville
Recruitment postcode(s) [1] 0 0
2127 - Liverpool
Recruitment postcode(s) [2] 0 0
2150 - Parramatta
Recruitment postcode(s) [3] 0 0
2135 - Strathfield
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
3002 - East Melbourne
Recruitment postcode(s) [6] 0 0
3178 - Rowville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Hawaii
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Massachusetts
Country [13] 0 0
United States of America
State/province [13] 0 0
Mississippi
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
New Jersey
Country [16] 0 0
United States of America
State/province [16] 0 0
New Mexico
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
North Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Ohio
Country [20] 0 0
United States of America
State/province [20] 0 0
Oklahoma
Country [21] 0 0
United States of America
State/province [21] 0 0
Oregon
Country [22] 0 0
United States of America
State/province [22] 0 0
Pennsylvania
Country [23] 0 0
United States of America
State/province [23] 0 0
South Carolina
Country [24] 0 0
United States of America
State/province [24] 0 0
South Dakota
Country [25] 0 0
United States of America
State/province [25] 0 0
Tennessee
Country [26] 0 0
United States of America
State/province [26] 0 0
Texas
Country [27] 0 0
United States of America
State/province [27] 0 0
Virginia
Country [28] 0 0
United States of America
State/province [28] 0 0
Washington
Country [29] 0 0
United States of America
State/province [29] 0 0
West Virginia
Country [30] 0 0
Argentina
State/province [30] 0 0
Santa Fe
Country [31] 0 0
Argentina
State/province [31] 0 0
Sante Fe
Country [32] 0 0
Argentina
State/province [32] 0 0
Ciudad Autonoma de Buenos Aire
Country [33] 0 0
Argentina
State/province [33] 0 0
Mendoza
Country [34] 0 0
Austria
State/province [34] 0 0
Graz
Country [35] 0 0
Brazil
State/province [35] 0 0
Minas Gerais
Country [36] 0 0
Brazil
State/province [36] 0 0
Rio Grande Do Sul
Country [37] 0 0
Brazil
State/province [37] 0 0
São Paulo
Country [38] 0 0
Bulgaria
State/province [38] 0 0
Sofia
Country [39] 0 0
Bulgaria
State/province [39] 0 0
Stara Zagora
Country [40] 0 0
Canada
State/province [40] 0 0
Ontario
Country [41] 0 0
Colombia
State/province [41] 0 0
Antioquia
Country [42] 0 0
Colombia
State/province [42] 0 0
Cundinamarca
Country [43] 0 0
Colombia
State/province [43] 0 0
VAlle Del Cauca
Country [44] 0 0
Colombia
State/province [44] 0 0
Barranquilla
Country [45] 0 0
Colombia
State/province [45] 0 0
Bogotá
Country [46] 0 0
Colombia
State/province [46] 0 0
Cali
Country [47] 0 0
Colombia
State/province [47] 0 0
Medellín
Country [48] 0 0
Croatia
State/province [48] 0 0
Osijek
Country [49] 0 0
Croatia
State/province [49] 0 0
Split
Country [50] 0 0
Croatia
State/province [50] 0 0
Zagreb
Country [51] 0 0
Czechia
State/province [51] 0 0
Cech Republic
Country [52] 0 0
Czechia
State/province [52] 0 0
Brno
Country [53] 0 0
Czechia
State/province [53] 0 0
Praha 2
Country [54] 0 0
Czechia
State/province [54] 0 0
Praha 4-Krc
Country [55] 0 0
Czechia
State/province [55] 0 0
Praha
Country [56] 0 0
Denmark
State/province [56] 0 0
Roskilde
Country [57] 0 0
Estonia
State/province [57] 0 0
Tallinn
Country [58] 0 0
France
State/province [58] 0 0
Cote-d'Or
Country [59] 0 0
France
State/province [59] 0 0
Rhone
Country [60] 0 0
France
State/province [60] 0 0
Vienne
Country [61] 0 0
France
State/province [61] 0 0
Paris
Country [62] 0 0
Germany
State/province [62] 0 0
Baden Wu
Country [63] 0 0
Germany
State/province [63] 0 0
Nordrhein Westfalen
Country [64] 0 0
Germany
State/province [64] 0 0
Rheinland Pfalz
Country [65] 0 0
Germany
State/province [65] 0 0
Berlin
Country [66] 0 0
Greece
State/province [66] 0 0
Athens
Country [67] 0 0
Greece
State/province [67] 0 0
Heraklion
Country [68] 0 0
Greece
State/province [68] 0 0
Larissa
Country [69] 0 0
Greece
State/province [69] 0 0
Thessaloníki
Country [70] 0 0
Hungary
State/province [70] 0 0
Budapest
Country [71] 0 0
Hungary
State/province [71] 0 0
Debrecen
Country [72] 0 0
Hungary
State/province [72] 0 0
Nyiregyhaza
Country [73] 0 0
Hungary
State/province [73] 0 0
Pécs
Country [74] 0 0
Hungary
State/province [74] 0 0
Zalaegerszeg
Country [75] 0 0
India
State/province [75] 0 0
Andhra Pradesh
Country [76] 0 0
India
State/province [76] 0 0
Jharkhand
Country [77] 0 0
India
State/province [77] 0 0
Karnataka
Country [78] 0 0
India
State/province [78] 0 0
Maharashtra
Country [79] 0 0
India
State/province [79] 0 0
Orissa
Country [80] 0 0
India
State/province [80] 0 0
Tamil Nadu
Country [81] 0 0
Israel
State/province [81] 0 0
Afula
Country [82] 0 0
Israel
State/province [82] 0 0
Haifa
Country [83] 0 0
Israel
State/province [83] 0 0
Jerusalem
Country [84] 0 0
Israel
State/province [84] 0 0
Re?ovot
Country [85] 0 0
Israel
State/province [85] 0 0
Tel Aviv
Country [86] 0 0
Italy
State/province [86] 0 0
Perugia
Country [87] 0 0
Italy
State/province [87] 0 0
Firenze
Country [88] 0 0
Italy
State/province [88] 0 0
Milano
Country [89] 0 0
Italy
State/province [89] 0 0
Milan
Country [90] 0 0
Italy
State/province [90] 0 0
Pisa
Country [91] 0 0
Italy
State/province [91] 0 0
Roma
Country [92] 0 0
Italy
State/province [92] 0 0
Rome
Country [93] 0 0
Italy
State/province [93] 0 0
Rozzano
Country [94] 0 0
Korea, Republic of
State/province [94] 0 0
Gyeonggi-do
Country [95] 0 0
Korea, Republic of
State/province [95] 0 0
Busan
Country [96] 0 0
Korea, Republic of
State/province [96] 0 0
Seoul
Country [97] 0 0
Korea, Republic of
State/province [97] 0 0
Soeul
Country [98] 0 0
Latvia
State/province [98] 0 0
Riga
Country [99] 0 0
Lithuania
State/province [99] 0 0
Kaunas
Country [100] 0 0
Lithuania
State/province [100] 0 0
Klaipeda
Country [101] 0 0
Lithuania
State/province [101] 0 0
Vilnius
Country [102] 0 0
Netherlands
State/province [102] 0 0
Nijmegen
Country [103] 0 0
Netherlands
State/province [103] 0 0
Rotterdam
Country [104] 0 0
Netherlands
State/province [104] 0 0
Tilburg
Country [105] 0 0
Philippines
State/province [105] 0 0
Batangas
Country [106] 0 0
Philippines
State/province [106] 0 0
Makati City
Country [107] 0 0
Philippines
State/province [107] 0 0
Makati
Country [108] 0 0
Philippines
State/province [108] 0 0
Pasig City
Country [109] 0 0
Philippines
State/province [109] 0 0
Quezon City
Country [110] 0 0
Poland
State/province [110] 0 0
Bielsko-Biala
Country [111] 0 0
Poland
State/province [111] 0 0
Bydgoszcz
Country [112] 0 0
Poland
State/province [112] 0 0
Bytom
Country [113] 0 0
Poland
State/province [113] 0 0
Lublin
Country [114] 0 0
Poland
State/province [114] 0 0
Olsztyn
Country [115] 0 0
Poland
State/province [115] 0 0
Poznan
Country [116] 0 0
Poland
State/province [116] 0 0
Lódz
Country [117] 0 0
Puerto Rico
State/province [117] 0 0
Arecibo
Country [118] 0 0
Slovakia
State/province [118] 0 0
Bratislava
Country [119] 0 0
Slovakia
State/province [119] 0 0
Trebišov
Country [120] 0 0
Slovakia
State/province [120] 0 0
Trencín
Country [121] 0 0
Slovakia
State/province [121] 0 0
Žilina
Country [122] 0 0
Spain
State/province [122] 0 0
Asturias
Country [123] 0 0
Spain
State/province [123] 0 0
Barcelona
Country [124] 0 0
Spain
State/province [124] 0 0
Madrid
Country [125] 0 0
Spain
State/province [125] 0 0
Valencia
Country [126] 0 0
Spain
State/province [126] 0 0
Zaragoza
Country [127] 0 0
Taiwan
State/province [127] 0 0
Kaohsiung
Country [128] 0 0
Taiwan
State/province [128] 0 0
Taichung
Country [129] 0 0
Taiwan
State/province [129] 0 0
Taipei
Country [130] 0 0
Taiwan
State/province [130] 0 0
Taoyuan City
Country [131] 0 0
United Kingdom
State/province [131] 0 0
Devon
Country [132] 0 0
United Kingdom
State/province [132] 0 0
Essex
Country [133] 0 0
United Kingdom
State/province [133] 0 0
Greater Manchester
Country [134] 0 0
United Kingdom
State/province [134] 0 0
Merseyside
Country [135] 0 0
United Kingdom
State/province [135] 0 0
Norfolk
Country [136] 0 0
United Kingdom
State/province [136] 0 0
Surrey
Country [137] 0 0
United Kingdom
State/province [137] 0 0
Tyne And Wear
Country [138] 0 0
United Kingdom
State/province [138] 0 0
West Yorkshire
Country [139] 0 0
United Kingdom
State/province [139] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Opthea Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A 2-year phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked study. Primary efficacy will be determined at Week 52.
Trial website
https://clinicaltrials.gov/study/NCT04757636
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04757636