AzTrials
AzTrials

Neovascular Age-related Macular DegenerationPhase 3ShOReNCT04757610

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

A Phase 3 study testing 2.0 mg OPT-302 and 0.5 mg ranibizumab in people with Neovascular Age-related Macular Degeneration, run by Opthea Limited at 191 sites in 24 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 0.5 mg ranibizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
986 participants
Where
191 sitesin 24 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 may apply

Who cannot join

None listed.

Trial locations and contacts

191 sites in 24 countries.

191 sites in 24 countries

United States76 sites

  • ShORe Investigational Site

    Arlington, Texas, 76012

  • ShORe Investigational Site

    Augusta, Georgia, 30909

  • ShORe Investigational Site

    Austin, Texas, 78705

  • ShORe Investigational Site

    Austin, Texas, 78731

  • ShORe Investigational Site

    Bakersfield, California, 93309

  • ShORe Investigational Site

    Baltimore, Maryland, 21209

  • ShORe Investigational Site

    Baltimore, Maryland, 21237

  • ShORe Investigational Site

    Beaufort, South Carolina, 29902

  • ShORe Investigational Site

    Bellaire, Texas, 77401

  • ShORe Investigational Site

    Bloomfield, New Jersey, 07003

  • ShORe Investigational Site

    Campbell, California, 95008

  • ShORe Investigational Site

    Charlottesville, Virginia, 22903

  • ShORe Investigational Site

    Clearwater, Florida, 33761

  • ShORe Investigational Site

    Colorado Springs, Colorado, 80909

  • ShORe Investigational Site

    Dallas, Texas, 75231

  • ShORe Investigational Site

    Denver, Colorado, 80206

  • ShORe Investigational Site

    Edmond, Oklahoma, 73013

  • ShORe Investigational Site

    Encino, California, 91436

  • ShORe Investigational Site

    Erie, Pennsylvania, 16507

  • ShORe Investigational Site

    Eugene, Oregon, 97401

  • ShORe Investigational Site

    Fargo, North Dakota, 58104

  • ShORe Investigational Site

    Fort Lauderdale, Florida, 33308

  • ShORe Investigational Site

    Fort Myers, Florida, 33912

  • ShORe Investigational Site

    Fullerton, California, 92835

  • ShORe Investigational Site

    Gainesville, Florida, 32607

  • ShORe Investigational Site

    Glendale, California, 91203

  • ShORe Investigational Site

    Hagerstown, Maryland, 21740

  • ShORe Investigational Site

    Hauppauge, New York, 11021

  • ShORe Investigational Site

    Houston, Texas, 77030

  • ShORe Investigational Site

    Huntington Beach, California, 92647

  • ShORe Investigational Site

    Indianapolis, Indiana, 46290

  • ShORe Investigational Site

    Katy, Texas, 77494

  • ShORe Investigational Site

    Ladson, South Carolina, 29456

  • ShORe Investigational Site

    Laguna Hills, California, 92653

  • ShORe Investigational Site

    Lakeland, Florida, 33805

  • ShORe Investigational Site

    Lakewood, Colorado, 80228

  • ShORe Investigational Site

    Lemont, Illinois, 60439

  • ShORe Investigational Site

    Liverpool, New York, 13088

  • ShORe Investigational Site

    Long Beach, California, 90807

  • ShORe Investigational Site

    Longmont, Colorado, 80503

  • ShORe Investigational Site

    Los Angeles, California, 95817

  • ShORe Investigational Site

    Lynchburg, Virginia, 24502

  • ShORe Investigational Site

    McAllen, Texas, 78503

  • ShORe Investigational Site

    Minneapolis, Minnesota, 55416

  • ShORe Investigational Site

    Mountain View, California, 94040

  • ShORe Investigational Site

    Nashville, Tennessee, 37203

  • ShORe Investigational Site

    Palm Desert, California, 92211

  • ShORe Investigational site

    Pasadena, California, 91107

  • ShORe Investigational Site

    Pensacola, Florida, 32503

  • ShORe Investigational Site

    Phoenix, Arizona, 85016

  • ShORe Investigational Site

    Phoenix, Arizona, 85050

  • ShORe Investigational Site

    Pinellas Park, Florida, 33782

  • ShORe Investigational Site

    Portland, Oregon, 97225

  • ShORe Investigational Site

    Portland, Oregon, 97239

  • ShORe Investiagtional Site

    Poway, California, 92064

  • ShORe Investigational Site

    Redlands, California, 92373

  • ShORe Investigational Site

    Reno, Nevada, 89502

  • ShORe Investigational Site

    Sacramento, California, 95817

  • ShORe Investigational Site

    Salem, Oregon, 97302

  • ShORe Investigational Site

    Salt Lake City, Utah, 84107

  • ShORe Investigational Site

    San Antonio, Texas, 78240

  • ShORe Investigational Site

    San Antonio, Texas, 78251

  • ShORe Investigational Site

    San Antonio, Texas, 78340

  • ShORe Investigational Site

    Sandy Springs, Georgia, 30328

  • ShORe Investigational Site

    Santa Ana, California, 92705

  • ShORe Investigational Site

    Springfield, Massachusetts, 01107

  • ShORe Investigational Site

    St Louis, Missouri, 63108

  • ShORe Investigational Site

    Temple Terrace, Florida, 33617

  • ShORe Investigational Site

    Toms River, New Jersey, 08755

  • ShORe Investigational Site

    Torrance, California, 90503

  • ShORe Investigational Site

    Towson, Maryland, 21204

  • ShORe Investigational Site

    Tucson, Arizona, 85704

  • ShORe Investigational Site

    Tulsa, Oklahoma, 74114

  • ShORe Investigational Site

    Tyler, Texas, 75701

  • ShORe Investigational Site

    Wake Forest, North Carolina, 27587

  • ShORe Investigational Site

    Willow Park, Texas, 76087

Other trials in United States

South Korea11 sites

  • ShORe Investigational Site

    Busan, 48108

  • ShORe Investigational Site

    Busan, 49201

  • ShORe Investigational Site

    Daegu, Gyeongsangbuk-do, 42415

  • ShORe Investigational Site

    Gwangju, 61469

  • ShORe Investigational Site

    Seongnam-si, Gyeonggi-do, 1360

  • ShORe Investigational Site

    Seoul, 3080

  • ShORe Investigational Site

    Seoul, 4401

  • ShORe Investigational Site

    Seoul, 5278

  • ShORe Investigational Site

    Seoul, 5505

  • ShORe Investigational Site

    Seoul, 7301

  • ShORe Investigational Site

    Seoul, 7441

Other trials in South Korea

Spain11 sites

  • ShORe Investigational Site

    Alcalá de Henares, Madrid, 28805

  • ShORe Investigational Site

    Barcelona, 8023

  • ShORe Investigational Site

    Barcelona, 8035

  • ShORe Investigational Site

    Burgos, 9006

  • ShORe Investigational Site

    Burjassot, Valencia, 46100

  • ShORe Investigational Site

    Córdoba, 14012

  • ShORe Investigational Site

    Madrid, 28035

  • ShORe Investigational Site

    Madrid, 28040

  • ShORe Investigational Site

    Pamplona, Navarre, 31008

  • ShORe Investigational Site

    Sant Cugat del Vallès, Barcelona, 8195

  • ShORe Investigational Site

    Valencia, 46015

Other trials in Spain

India10 sites

  • ShORe Investigational Site

    Ahmedabad, Gujarat, 380016

  • ShORe Investigational Site

    Bangalore, Karnataka, 560037

  • ShORe Investigational Site

    Bangalore, Karnataka, 560094

  • ShORe Investigational Site

    Chandigarh, Punjab, 160012

  • ShORe Investigational Site

    Coimbatore, Tamil Nadu, 641035

  • ShORe Investigational Site

    Kolkata, West Bengal, 700073

  • ShORe Investigational Site

    Lucknow, Uttar Pradesh, 226010

  • ShORe Investigational Site

    Mysuru, 570004

  • ShORe Investigational Site

    Pune, Maharashtra, 411060

  • ShORe Investigational Site

    Surat, Gujarat, 395001

Other trials in India

Germany8 sites

  • ShORe Investigational Site

    Bonn, North Rhine-Westphalia, 53127

  • ShORe Investigational Site

    Düsseldorf, Nordrhein, 40225

  • ShORe Investigational Site

    Goettigen, Lower Saxony, 37075

  • ShORe Investigational Site

    Hamburg, 20246

  • ShORe Investigational Site

    Heidelberg, Baden-Wurttemberg, 69120

  • ShORe Investigational Site

    Münster, Nordrhein, 48145

  • ShORe Investigational Site

    Münster, North Rhine-Westphalia, 48149

  • ShORe Investigational Site

    Ulm, Baden Wuerttermberg, 89075

Other trials in Germany

United Kingdom8 sites

  • ShORe Investigational Site

    Bristol, Somerset, BS12LX

  • ShORe Investigational Site

    Crewe, Cheshire, CW1 4QJ

  • ShORe Investigational Site

    Guildford, Surrey, GU27XX

  • ShORe Investigational Site

    Leicester, Leicestershire, LE15 WW

  • ShORe Investigational Site

    London, SE59RS

  • ShORe Investigational Site

    London, W1G 7LB

  • ShORe Investigational Site

    Southampton, Hampshire, SO16 6YD

  • ShORe Investigational Site

    Wolverhampton, West Midlands, WV10 0QP

Other trials in United Kingdom

Argentina7 sites

  • ShORe Investigational Site

    Buenos Aires, 1832

  • ShORe Investigational Site

    Buenos Aires, B1629ODT

  • ShORe Investigational Site

    Capital Federal, Ciudad Autonoma Buenos Aires, C1120AAN

  • ShORe Investigational Site

    Ciudad Autonoma de Buenos Aire, C1015ABO

  • ShORe Investigational Site

    Córdoba, 5000

  • ShORe Investigational Site

    Rosario, Santa Fe Province, S2000ANJ

  • ShORe Investigational Site

    Rosario, Sante Fe, S2000DLA

Other trials in Argentina

Brazil7 sites

  • ShORe Investigational site

    Blumenau, Santa Catarina, 89052-504

  • ShORe Investigational Site

    Faxinal do Soturno, Rio Grande do Sul, 97220-000

  • ShORe Investigational Site

    Goiânia, Goiás, 74210-01

  • ShORe Investigational Site

    Santo André, São Paulo, 09060-870

  • ShORe Investigational Site

    São Paulo, 1525

  • ShORe Investigational Site

    São Paulo, 18031-060

  • ShORe Investigational Site

    Vitória, Cordoba, 5000

Other trials in Brazil

Italy7 sites

  • ShORe Investigational Site

    Bologna, 40138

  • ShORe Investigational Site

    Catanzaro, Reggio Calabria, 88100

  • ShORe Investigational Site

    Chieti, 66100

  • ShORe Investiagational Site

    Genova, 16132

  • ShORe Investigational Site

    Roma, 00168

  • ShORe Investigational Site

    Siena, C1120AAN

  • ShORe Investigational Site

    Udine, 33100

Other trials in Italy

Poland7 sites

  • ShORe Investigational Site

    Gdansk, 80822

  • ShORe Investigational Site

    Krakow, 31070

  • ShORe Investigational Site

    Olsztyn, 10-424

  • ShORe Investigational Site

    Szczecin, 70-111

  • ShORe Investigational Site

    Tarnowskie Góry, 42-600

  • ShORe Investigational Site

    Warsaw, 00631

  • ShORe Investigational Site

    Wroclaw, 50-556

Other trials in Poland

Israel5 sites

  • ShORe Investigational Site

    Beersheba, 8410101

  • ShORe Investigational Site

    Haifa, 3109601

  • ShORe Investigational Site

    Kfar Saba, 4428164

  • ShORe Investigational Site

    Petah Tikva, 4941492

  • ShORe Investigational Site

    Rishon LeZiyyon, 70300

Other trials in Israel

Canada4 sites

  • ShORe Investigational Site

    Calgary, Alberta, T2A 0Z9

  • ShORe Investigational Site

    Edmonton, Alberta, AB T5H 0X5

  • ShORe Investigational Site

    Edmonton, Alberta, AB T5H OX5

  • ShORe Investigational Site

    Mississauga, Ontario, L4W1W9

Other trials in Canada

Czechia4 sites

  • ShORe Investigational Site

    Pardubice, 53002

  • ShORe Investigational Site

    Prague, 10034

  • ShORe Investigational Site

    Prague, 15800

  • ShORe Investigational Site

    Sokolov, 356 01

Other trials in Czechia

France4 sites

  • ShORe Investigational Site

    Créteil, Val de Marr, 94000

  • ShORe Investigational Site

    Écully, Rhone, 69130

  • ShORe Investigational Site

    Nice, Alpes-Maritimes, 6000

  • ShORe Investigational Site

    Strasbourg, Bas Rhin, 6700

Other trials in France

Thailand4 sites

  • ShORe Investigational Site

    Chiang Mai, 50200

  • ShORe Investigational Site

    Khon Kaen, 40002

  • ShORe Investigational Site

    Pathum Thani, 12121

  • ShORe Investigational Site

    Pathum Wan, Bangkok, 10330

Other trials in Thailand

Denmark3 sites

  • ShORe Investigational Site

    Aarhus, 8200

  • ShORe Investigational Site

    Glostrup Municipality, 2600

  • ShORe Investigational Site

    Sønderborg, 6400

Other trials in Denmark

Greece3 sites

  • ShORe Investigational Site

    Athens, 11527

  • ShORe Investigational Site

    Ioannina, 4550

  • ShORe Investigational Site

    Pátrai, 26504

Other trials in Greece

Hungary3 sites

  • ShORe Investigational Site

    Budapest, 1133

  • ShORe Investigational Site

    Miskolc, 3050

  • ShORe Investigational Site

    Szombathely, 9700

Other trials in Hungary

Malaysia3 sites

  • ShORe Investigational Site

    Batu Caves, Selangor, 68100

  • ShORe Investigational Site

    Kuala Lumpur, 59200

  • ShORe Investigational Site

    Shah Alam, Selangor, 4000

Other trials in Malaysia

Australia2 sites

  • ShORe Investigational Site

    Hurstville, New South Wales, 2220

  • ShORe Investigational Site

    Melbourne, Victoria, 3050

Other trials in Australia

Bulgaria1 site

  • ShORe Investigational Site

    Sofia, 1407

Other trials in Bulgaria

Colombia1 site

  • ShORe Investigational Site

    Medellín

Other trials in Colombia

Latvia1 site

  • ShORe Investigational Site

    Riga, LV-1002

Other trials in Latvia

Ukraine1 site

  • ShORe Investigational Site

    Kiev

Other trials in Ukraine

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 Ranibizumab, Compared With Ranibizumab 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, 0.5 mg ranibizumab, Sham

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

  • 0.5 mg ranibizumabBiological

    intravitreal injection

  • ShamProcedure or surgery

    intravitreal injection

Study groups in NCT04757610
Study groupRoleWhat they receive
0.5 mg ranibizumab with Standard Dosing 2.0 mg OPT-302Experimental0.5 mg ranibizumab intravitreal injection administered at 4-weekly intervals. 2.0 mg OPT-302 intravitreal injection administered at 4-weekly intervals.
Receives: Biological: 2.0 mg OPT-302; Biological: 0.5 mg ranibizumab
0.5 mg ranibizumab with Extended Dosing 2.0 mg OPT-302Experimental0.5 mg ranibizumab intravitreal injection administered at 4-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: 0.5 mg ranibizumab
0.5 mg ranibizumab with shamSham comparator0.5 mg ranibizumab intravitreal injection administered at 4-weekly intervals. Sham intravitreal injection administered at 4-weekly intervals.
Receives: Biological: 0.5 mg ranibizumab; 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 Diabetic 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 0.5 mg ranibizumab, 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. 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 0.5 mg ranibizumab, 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.

    Measured: Baseline to Week 52

  2. Participants Gaining 10 More ETDRS BCVA Letters

    To determine the effects of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 0.5 mg ranibizumab, 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.

    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 0.5 mg ranibizumab, 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.

    Measured: Baseline to Week 52

  4. 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 0.5 mg ranibizumab, 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.

    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
986 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04757610
Sponsor's protocol ID
OPT-302-1004
Acronym
ShORe
Status last verified
Jun 2025
First submitted
12 Feb 2021
Last updated
22 Jul 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 0.5 mg ranibizumab in people with Neovascular Age-related Macular Degeneration, run by Opthea Limited at 191 sites in 24 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 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 191 sites in United States, South Korea, Spain, India, Germany and 19 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 22 Jul 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 Diabetic 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 NCT04757610.

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 22 Jul 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in