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Neovascular Age-related Macular DegenerationPhase 3COASTNCT04757636

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

A Phase 3 study testing 2.0 mg OPT-302 and 2.0 aflibercept in people with Neovascular Age-related Macular Degeneration, run by Opthea Limited at 209 sites in 30 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 50 years and older
What is being tested?
2.0 mg OPT-302 and 2.0 aflibercept
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
998 participants
Where
209 sitesin 30 countries
Study dates
12 Mar 2021to 31 Mar 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

None listed.

Trial locations and contacts

209 sites in 30 countries.

209 sites in 30 countries

United States60 sites

  • COAST Investigational Site

    ‘Aiea, Hawaii, 96701

  • COAST Investigational Site

    Abilene, Texas, 79606

  • COAST Investigational Site

    Albuquerque, New Mexico, 87109

  • COAST Investigational Site

    Altamonte Springs, Florida, 32750

  • COAST Investigational Site

    Arcadia, California, 91006

  • COAST Investigational Site

    Asheville, North Carolina, 28803

  • COAST Investigational Site

    Austin, Texas, 78705

  • COAST Investigational Site

    Bellevue, Washington, 98004

  • COAST Investigational Site

    Boston, Massachusetts, 02114

  • COAST Investigational Site

    Boynton Beach, Florida, 33426

  • COAST Investigational Site

    Burleson, Texas, 76028

  • COAST Investigational Site

    Chicago, Illinois, 60611

  • COAST Investigational Site

    Cincinnati, Ohio, 45202

  • COAST Investigational Site

    Conroe, Texas, 77384

  • COAST Investigational Site

    Coral Springs, Florida, 33067

  • COAST Investigational Site

    Dallas, Texas, 75243

  • COAST Investigational Site

    Danbury, Connecticut, 06810

  • COAST Investigational Site

    Dayton, Ohio, 45459

  • COAST Investigational Site

    Edison, New Jersey, 08820

  • COAST Investigational Site

    Fairfax, Virginia, 22031

  • COAST Investigational Site

    Germantown, Tennessee, 38138

  • COAST Investigational Site

    Greenville, South Carolina, 29605

  • COAST Investigational Site

    Hagerstown, Maryland, 21740

  • COAST Investigational Site

    Huntington Beach, California, 92647

  • COAST Investigational Site

    Independence, Missouri, 64055

  • COAST Investigational Site

    Jackson, Mississippi, 39202

  • COAST Investigational Site

    Kingston, Pennsylvania, 18704

  • COAST Investigational Site

    Knoxville, Tennessee, 37922

  • COAST Investigational Site

    Lenexa, Kansas, 66215

  • COAST Investigational Site

    Marietta, Georgia, 30060

  • COAST Investigational Site

    Melbourne, Florida, 32901

  • COAST Investigational Site

    Morgantown, West Virginia, 26505

  • COAST Investigational Site

    New Albany, Indiana, 47150

  • COAST Investigational Site

    Oklahoma City, Oklahoma, 73102

  • COAST Investigational Site

    Orlando, Florida, 32806

  • COAST Investigational Site

    Owings Mills, Maryland, 21117

  • COAST Investigational Site

    Philadelphia, Pennsylvania, 19107

  • COAST Investigational Site

    Phoenix, Arizona, 85053

  • COAST Investigational Site

    Plano, Texas, 75075

  • COAST Investigational Site

    Plantation, Florida, 33324

  • COAST Investigational Site

    Prairie Village, Kansas, 66208

  • COAST Investigational Site

    Rapid City, South Dakota, 57701

  • COAST Investigational Site

    Redlands, California, 92374

  • COAST Investigational Site

    Round Rock, Texas, 78681

  • COAST Investigational Site

    Sacramento, California, 95841

  • COAST Investigational Site

    Sarasota, Florida, 34239

  • COAST Investigational site

    Shirley, New York, 11967

  • COAST Investigational Site

    Spokane, Washington, 99204

  • COAST Investigational Site

    Springfield, Illinois, 62704

  • COAST Investigational Site

    Springfield, Oregon, 97477

  • COAST Investigational Site

    St Louis, Missouri, 63128

  • COAST Investigational Site

    St. Petersburg, Florida, 33711

  • COAST Investigational Site

    Stuart, Florida, 34994

  • COAST Investigational Site

    Urbana, Illinois, 61822

  • COAST Investigational Site

    West Columbia, South Carolina, 29169

  • COAST Investigational Site

    West Monroe, Louisiana, 71291

  • COAST Investigational Site

    Wilmington, North Carolina, 28401

  • COAST Investigational Site

    Winston-Salem, North Carolina, 27157

  • COAST Investigational Site

    Winter Haven, Florida, 33880

  • COAST Investigational Site

    Worcester, Massachusetts, 01605

Other trials in United States

Hungary10 sites

  • COAST Investigational Site

    Budapest, 1068

  • COAST Investigational Site

    Budapest, 1076

  • COAST Investigational Site

    Budapest, 1085

  • COAST Investigational Site

    Budapest, 1106

  • COAST Investigational Site

    Budapest, 1115

  • COAST Investigational Site

    Debrecen, 4032

  • COAST Investigational Site

    Nyíregyháza, 4400

  • COAST Investigational Site

    Pécs, 7621

  • COAST Investigational Site

    Pécs, 7632

  • COAST Investigational Site

    Zalaegerszeg, 8900

Other trials in Hungary

Spain10 sites

  • COAST Investigational Site

    Badalona, Barcelona, 8916

  • COAST Investigational Site

    Barcelona, 8022

  • COAST Investigational Site

    Barcelona, 8035

  • COAST Investigational Site

    Barcelona, 8907

  • COAST Investigational Site

    Madrid, 28008

  • COAST Investigational Site

    Majadahonda, Madrid, 28222

  • COAST Investigational Site

    Oviedo, Principality of Asturias, 33012

  • COAST Investigational Site

    Valencia, 46015

  • COAST Investigational Site

    Zaragoza, 500009

  • COAST Investigational Site

    Zaragoza, 50009

Other trials in Spain

Italy9 sites

  • COAST Investigational Site

    Ancona, Perugia, 6132

  • COAST Investigational Site

    Florence, 50134

  • COAST Investigational Site

    Milan, 20122

  • COAST Investigational Site

    Milan, 20132

  • COAST Investigational Site

    Milan, 20157

  • COAST Investigational Site

    Pisa, 56126

  • COAST Investigational Site

    Roma, 198

  • COAST Investigational Site

    Rome, 133

  • COAST Investigational Site

    Rozzano, 20089

Other trials in Italy

South Korea9 sites

  • COAST Investigational Site

    Busan, 49241

  • COAST Investigational Site

    Seongnam-si, Gyeonggi-do, 13496

  • COAST Investigational Site

    Seoul, 2447

  • COAST Investigational Site

    Seoul, 2841

  • COAST Investigational Site

    Seoul, 6273

  • COAST Investigational Site

    Seoul, 6351

  • COAST Investigational Site

    Seoul, 7061

  • COAST Investigational Site

    Soeul, 6198

  • COAST Investigational Site

    Suwon, Gyeonggi-do, 16499

Other trials in South Korea

United Kingdom9 sites

  • COAST Investigational Site

    Frimley, Surrey, GU167UJ

  • COAST Investigational Site

    Gorleston-on-Sea, Norfolk, NR31 6LA

  • COAST Investigational Site

    Leeds, West Yorkshire, LS9 7TF

  • COAST Investigational Site

    Liverpool, Merseyside, L7 8XP

  • COAST Investigational Site

    London, EC1V 2PD

  • COAST Investigational Site

    Manchester, Greater Manchester, M13 9WL

  • COAST Investigational Site

    Plymouth, Devon, PL6 5fp

  • COAST Investigational Site

    Sunderland, Tyne and Wear, SR2 9HP

  • COAST Investigational Site

    Westcliff-on-Sea, Essex, SSO 0RY

Other trials in United Kingdom

Poland8 sites

  • COAST Investigational Site

    Bielsko-Biala, 43-309

  • COAST Investigational Site

    Bydgoszcz, 85-631

  • COAST Investigational Site

    Bydgoszcz, 85-870

  • COAST Investigational Site

    Bytom, 41-902

  • COAST Investigational Site

    Lodz, 90-302

  • COAST Investigational Site

    Lublin, 20-064

  • COAST Investigational Site

    Olsztyn, 10-561

  • COAST Investigational Site

    Poznan, 60-538

Other trials in Poland

Colombia7 sites

  • COAST Investigational Site

    Barranquilla, 80002

  • COAST Investigational Site

    Bogotá, Cundinamarca, 110121

  • COAST Investigational Site

    Bogotá, 110231

  • COAST Investigational Site

    Cali, Valle del Cauca Department, 760042

  • COAST Investigational Site

    Cali, 760036

  • COAST Investigational Site

    Medellín, Antioquia, 50016

  • COAST Investigational Site

    Medellín, 5001

Other trials in Colombia

Israel7 sites

  • COAST Investigational Site

    Afula, 18101

  • COAST Investigational Site

    Haifa, 3434104

  • COAST Investigational Site

    Haifa

  • COAST Investigational Site

    Jerusalem, 9103102

  • COAST Investigational Site

    Jerusalem, 91120

  • COAST Investigational Site

    Rehovot, 7661041

  • COAST Investigational Site

    Tel Aviv, 6423906

Other trials in Israel

Argentina6 sites

  • COAST Investigational Site

    Ciudad Autonoma de Buenos Aire, C1023AAQ

  • COAST Investigational Site

    Ciudad Autonoma de Buenos Aire, C1061AAE

  • COAST Investigational Site

    Ciudad Autonoma de Buenos Aire, C1116ABA

  • COAST Investigational Site

    Mendoza, 5500

  • COAST Investigational Site

    Rosario, Santa Fe Province, S2000CTC

  • COAST Investigational Site

    Rosario, Sante Fe, S2000DSK

Other trials in Argentina

Australia6 sites

  • COAST Investigational Site

    Adelaide, South Australia, 5000

  • COAST Investigational Site

    East Melbourne, Victoria, 3002

  • COAST Investigational Site

    Liverpool, New South Wales, 2127

  • COAST Investigational Site

    Parramatta, New South Wales, 2150

  • COAST Investigational Site

    Rowville, Victoria, 3178

  • COAST Investigational Site

    Strathfield, New South Wales, 2135

Other trials in Australia

Czechia6 sites

  • COAST Investigational Site

    Brno, 625 00

  • COAST Investigational Site

    Hradec Králové, Cech Republic

  • COAST Investigational Site

    Prague, 100 34

  • COAST Investigational Site

    Prague, 12808

  • COAST Investigational Site

    Prague, 15000

  • COAST Investigational Site

    Praha 4-Krc, 140 59

Other trials in Czechia

India6 sites

  • COAST Investigational Site

    Bhubaneswar, Odisha, 751024

  • COAST Investigational Site

    Hyderabad, Andhra Pradesh, 500034

  • COAST Investigational Site

    Madurai, Tamil Nadu, 625020

  • COAST Investigational Site

    Mysore, Karnataka, 570001

  • COAST Investigational Site

    Nashik, Maharashtra, 422005

  • COAST Investigational Site

    Ranchi, Jharkhand, 834001

Other trials in India

Taiwan6 sites

  • COAST Investigational Site

    Kaohsiung City, 333

  • COAST Investigational Site

    Kaohsiung City, 807

  • COAST Investigational Site

    Taichung, 404327

  • COAST Investigational Site

    Taipei, 111

  • COAST Investigational Site

    Taipei, 11217

  • COAST Investigational Site

    Taoyuan City, 333

Other trials in Taiwan

Brazil5 sites

  • COAST Investigational Site

    Belo Horizonte, Minas Gerais, 30330-000

  • COAST Investigational Site

    Porto Alegre, Rio Grande do Sul, 90410-000

  • COAST Investigational Site

    São Paulo, 01427-002

  • COAST Investigational Site

    São Paulo, 04038-032

  • COAST Investigational Site

    São Paulo, 04084-002

Other trials in Brazil

Philippines5 sites

  • COAST Investigational Site

    Makati, 1209

  • COAST Investigational Site

    Makati City, 1200

  • COAST Investigational Site

    Pasig, 1604

  • COAST Investigational Site

    Quezon City, 1112

  • COAST Investigational Site

    Santo Tomas, Batangas, 4234

Other trials in Philippines

Canada4 sites

  • COAST Investigational Site

    Brampton, Ontario, L6Y 0P6

  • COAST Investigational Site

    North York, Ontario, M3C 0GP

  • COAST Investigational Site

    Ottawa, Ontario, K1H 8L6

  • COAST Investigational Site

    Ottawa, Ontario, K2B7E9

Other trials in Canada

Croatia4 sites

  • COAST Investigational Site

    Osijek, 31000

  • COAST Investigational Site

    Osijek, 3100

  • COAST Investigational Site

    Split, 21000

  • COAST Investigational Site

    Zagreb, 1000

Other trials in Croatia

France4 sites

  • COAST Investigational Site

    Dijon, 21079

  • COAST Investigational Site

    Lyon, Rhone, 69004

  • COAST Investigational Site

    Paris, 75010

  • COAST Investigational Site

    Poitiers, Vienne, 86021

Other trials in France

Germany4 sites

  • COAST Investigational Site

    Berlin, 12003

  • COAST Investigational Site

    Cologne, North Rhine-Westphalia, 50937

  • COAST Investigational Site

    Mainz, Rhineland-Palatinate, 55131

  • COAST Investigational Site

    Tübingen, Baden Wu, 72076

Other trials in Germany

Greece4 sites

  • COAST Investigational Site

    Athens, 12462

  • COAST Investigational Site

    Heraklion, 71003

  • COAST Investigational Site

    Larissa, 41110

  • COAST Investigational Site

    Thessaloniki, 56403

Other trials in Greece

Slovakia4 sites

  • COAST Investigational Site

    Bratislava, 821 01

  • COAST Investigational Site

    Trebišov, 075 01

  • COAST Investigational Site

    Trenčín, 91171

  • COAST Investigational Site

    Žilina, 012 07

Other trials in Slovakia

Estonia3 sites

  • COAST Investigational Site

    Tallinn, 10138

  • COAST Investigational Site

    Tallinn, 11314

  • COAST Investigational Site

    Tallinn, 11412

Other trials in Estonia

Lithuania3 sites

  • COAST Investigational Site

    Kaunas, LT-50161

  • COAST Investigational Site

    Klaipėda, 92288

  • COAST Investigational Site

    Vilnius, LT-08661

Other trials in Lithuania

Netherlands3 sites

  • COAST Investigational Site

    Nijmegen, 6525 EX

  • COAST Investigational Site

    Rotterdam, 3011 BH

  • COAST Investigational Site

    Tilburg, 5022 GC

Other trials in Netherlands

Bulgaria2 sites

  • COAST Investigational Site

    Sofia, 1431

  • COAST Investigational Site

    Stara Zagora, 6000

Other trials in Bulgaria

Latvia2 sites

  • COAST Investigational Site

    Riga, LV-1002

  • COAST Investigational Site

    Riga, LV-1006

Other trials in Latvia

Austria1 site

  • COAST Investigational Site

    Graz, 8036

Other trials in Austria

Denmark1 site

  • COAST Investigational Site

    Roskilde, 4000

Other trials in Denmark

Puerto Rico1 site

  • COAST Investigational Site

    Arecibo, 612

Other trials in Puerto Rico

About this study

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

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

Being tested
2.0 mg OPT-302, 2.0 aflibercept, Sham
Keywords
nAMD, wet AMD, Wet Macular Degeneration, Macular Degeneration, Eye Diseases, Retinal Diseases, Retinal Degeneration
Medical subject headings
Wet Macular Degeneration, Macular Degeneration, Eye Diseases, Retinal Diseases, Retinal Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 2.0 mg OPT-302Biological

    intravitreal injection

  • 2.0 afliberceptBiological

    intravitreal injection

  • ShamProcedure or surgery

    intravitreal injection

Study groups in NCT04757636
Study groupRoleWhat they receive
2.0 mg aflibercept with Standard Dosing 2.0 mg OPT-302Experimental2.0 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.
Receives: Biological: 2.0 mg OPT-302; Biological: 2.0 aflibercept
2.0 mg aflibercept with Extended Dosing 2.0 mg OPT-302Experimental2.0 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.
Receives: Biological: 2.0 mg OPT-302; Biological: 2.0 aflibercept
2.0 mg aflibercept with shamSham comparator2.0 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.
Receives: Biological: 2.0 aflibercept; Procedure: Sham

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Change in Early Treatment Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letters

    To determine the efficacy of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 2.0 mg aflibercept, in participants with neovascular age-related macular degeneration (nAMD), in terms of change in ETDRS BCVA letter score in the study eye from Baseline to Week 52. The primary analysis presented used mixed model for repeated measures in the overall population. (A positive outcome measure means an improvement in ETDRS BCVA letter score from baseline; a negative outcome measure means a deterioration in ETDRS BCVA letter score from baseline)

    Measured: Baseline to Week 52

Secondary outcomes (4)

  1. Proportion of Participants Gaining 15 or More ETDRS BCVA Letters

    To determine the effects of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 2.0 mg aflibercept, in participants with neovascular age-related macular degeneration (nAMD), in terms of proportion of participants gaining 15 or more letters in ETDRS BCVA in the study eye from Baseline to Week 52. The secondary analysis presented used multiple imputation analysis assuming missing at random in the overall population.

    Measured: Baseline to Week 52

  2. Proportion of Participants Gaining 10 or More ETDRS BCVA Letters

    To determine the effects of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 2.0 mg aflibercept, in participants with neovascular age-related macular degeneration (nAMD), in terms of proportion of participants gaining 10 or more letters in ETDRS BCVA in the study eye from Baseline to Week 52. The secondary analysis presented used multiple imputation analysis assuming missing at random in the overall population.

    Measured: Baseline to Week 52

  3. Change in Choroidal Neovascularisation (CNV) Area by Fluorescein Angiography (FA)

    To determine the effects of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 2.0 mg aflibercept, in participants with neovascular age-related macular degeneration (nAMD), in terms of change in CNV area as measured by FA in the study eye from Baseline to Week 52. The secondary analysis presented used mixed model for repeated measures in the overall population.

    Measured: Baseline to Week 52

  4. Proportion of Participants With Absence of Both Sub-retinal Fluid and Intra-retinal Cysts by SD-OCT

    To determine the effects of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 2.0 mg aflibercept, in participants with neovascular age-related macular degeneration (nAMD), in terms of proportion of participants with absence of both sub-retinal fluid and intra-retinal cysts by SD-OCT in the study eye at Week 52. The secondary analysis presented used multiple imputation analysis assuming missing at random in the overall population.

    Measured: at Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2021
  2. Study start12 Mar 2021
  3. Primary completion31 Mar 2025
  4. Study completion31 Mar 2025

Why it stopped: The primary endpoint was not achieved in the study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
998 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04757636
Sponsor's protocol ID
OPT-302-1005
Acronym
COAST
Status last verified
Jun 2025
First submitted
12 Feb 2021
Last updated
5 Aug 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 2.0 mg OPT-302 and 2.0 aflibercept in people with Neovascular Age-related Macular Degeneration, run by Opthea Limited at 209 sites in 30 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 209 sites in United States, Hungary, Spain, Italy, South Korea and 25 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change in Early Treatment Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letters (time frame: Baseline to Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04757636.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025; AzTrials last refreshed its copy on 26 Oct 2026.

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