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

NCT04757636 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: OPT-302-1005
• Study Type: interventional
• Target: 998
• Locations: 28 countries
• Sites: 200

Brief Summary

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

Conditions

Neovascular Age-related Macular Degeneration

Keywords

nAMD; wet AMD; Wet Macular Degeneration; Macular Degeneration; Eye Diseases; Retinal Diseases; Retinal Degeneration

Outcome Measures

Primary Outcomes (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)

  Baseline to Week 52

Secondary Outcomes (4)

• Proportion of Participants Gaining 15 or More ETDRS BCVA Letters

  Baseline to Week 52

• Proportion of Participants Gaining 10 or More ETDRS BCVA Letters

  Baseline to Week 52

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

  Baseline to Week 52

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

  at Week 52

Study Arms (3)

2.0 mg aflibercept with Standard Dosing 2.0 mg OPT-302

EXPERIMENTAL

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.

Biological: 2.0 mg OPT-302; Biological: 2.0 aflibercept

2.0 mg aflibercept with Extended Dosing 2.0 mg OPT-302

EXPERIMENTAL

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.

Biological: 2.0 mg OPT-302; Biological: 2.0 aflibercept

2.0 mg aflibercept with sham

SHAM COMPARATOR

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.

Biological: 2.0 aflibercept; Procedure: Sham

Interventions

2.0 mg OPT-302 BIOLOGICAL

intravitreal injection

2.0 mg aflibercept with Extended Dosing 2.0 mg OPT-302; 2.0 mg aflibercept with Standard Dosing 2.0 mg OPT-302

2.0 aflibercept BIOLOGICAL

intravitreal injection

2.0 mg aflibercept with Extended Dosing 2.0 mg OPT-302; 2.0 mg aflibercept with Standard Dosing 2.0 mg OPT-302; 2.0 mg aflibercept with sham

Sham PROCEDURE

intravitreal injection

2.0 mg aflibercept with sham

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Opthea Limited: lead

Study Sites (209)

COAST Investigational Site

Phoenix, Arizona, 85053, United States

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COAST Investigational Site

Arcadia, California, 91006, United States

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COAST Investigational Site

Huntington Beach, California, 92647, United States

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COAST Investigational Site

Redlands, California, 92374, United States

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COAST Investigational Site

Sacramento, California, 95841, United States

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COAST Investigational Site

Danbury, Connecticut, 06810, United States

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COAST Investigational Site

Altamonte Springs, Florida, 32750, United States

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COAST Investigational Site

Boynton Beach, Florida, 33426, United States

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COAST Investigational Site

Coral Springs, Florida, 33067, United States

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COAST Investigational Site

Melbourne, Florida, 32901, United States

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COAST Investigational Site

Orlando, Florida, 32806, United States

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COAST Investigational Site

Plantation, Florida, 33324, United States

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COAST Investigational Site

Sarasota, Florida, 34239, United States

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COAST Investigational Site

St. Petersburg, Florida, 33711, United States

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COAST Investigational Site

Stuart, Florida, 34994, United States

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COAST Investigational Site

Winter Haven, Florida, 33880, United States

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COAST Investigational Site

Marietta, Georgia, 30060, United States

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COAST Investigational Site

‘Aiea, Hawaii, 96701, United States

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COAST Investigational Site

Chicago, Illinois, 60611, United States

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COAST Investigational Site

Springfield, Illinois, 62704, United States

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COAST Investigational Site

Urbana, Illinois, 61822, United States

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COAST Investigational Site

New Albany, Indiana, 47150, United States

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COAST Investigational Site

Lenexa, Kansas, 66215, United States

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COAST Investigational Site

Prairie Village, Kansas, 66208, United States

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COAST Investigational Site

West Monroe, Louisiana, 71291, United States

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COAST Investigational Site

Hagerstown, Maryland, 21740, United States

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COAST Investigational Site

Owings Mills, Maryland, 21117, United States

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COAST Investigational Site

Boston, Massachusetts, 02114, United States

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COAST Investigational Site

Worcester, Massachusetts, 01605, United States

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COAST Investigational Site

Jackson, Mississippi, 39202, United States

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COAST Investigational Site

Independence, Missouri, 64055, United States

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COAST Investigational Site

St Louis, Missouri, 63128, United States

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COAST Investigational Site

Edison, New Jersey, 08820, United States

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COAST Investigational Site

Albuquerque, New Mexico, 87109, United States

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COAST Investigational site

Shirley, New York, 11967, United States

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COAST Investigational Site

Asheville, North Carolina, 28803, United States

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COAST Investigational Site

Wilmington, North Carolina, 28401, United States

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COAST Investigational Site

Winston-Salem, North Carolina, 27157, United States

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Cincinnati, Ohio, 45202, United States

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COAST Investigational Site

Dayton, Ohio, 45459, United States

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COAST Investigational Site

Oklahoma City, Oklahoma, 73102, United States

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COAST Investigational Site

Springfield, Oregon, 97477, United States

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COAST Investigational Site

Kingston, Pennsylvania, 18704, United States

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COAST Investigational Site

Philadelphia, Pennsylvania, 19107, United States

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COAST Investigational Site

Greenville, South Carolina, 29605, United States

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COAST Investigational Site

West Columbia, South Carolina, 29169, United States

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COAST Investigational Site

Rapid City, South Dakota, 57701, United States

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COAST Investigational Site

Germantown, Tennessee, 38138, United States

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COAST Investigational Site

Knoxville, Tennessee, 37922, United States

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COAST Investigational Site

Abilene, Texas, 79606, United States

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COAST Investigational Site

Austin, Texas, 78705, United States

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COAST Investigational Site

Burleson, Texas, 76028, United States

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COAST Investigational Site

Conroe, Texas, 77384, United States

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COAST Investigational Site

Dallas, Texas, 75243, United States

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COAST Investigational Site

Plano, Texas, 75075, United States

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COAST Investigational Site

Round Rock, Texas, 78681, United States

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COAST Investigational Site

Fairfax, Virginia, 22031, United States

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COAST Investigational Site

Bellevue, Washington, 98004, United States

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COAST Investigational Site

Spokane, Washington, 99204, United States

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COAST Investigational Site

Morgantown, West Virginia, 26505, United States

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COAST Investigational Site

Rosario, Santa Fe Province, S2000CTC, Argentina

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COAST Investigational Site

Rosario, Sante Fe, S2000DSK, Argentina

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COAST Investigational Site

Ciudad Autonoma de Buenos Aire, C1023AAQ, Argentina

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COAST Investigational Site

Ciudad Autonoma de Buenos Aire, C1061AAE, Argentina

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COAST Investigational Site

Ciudad Autonoma de Buenos Aire, C1116ABA, Argentina

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COAST Investigational Site

Mendoza, 5500, Argentina

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COAST Investigational Site

Liverpool, New South Wales, 2127, Australia

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COAST Investigational Site

Parramatta, New South Wales, 2150, Australia

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COAST Investigational Site

Strathfield, New South Wales, 2135, Australia

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COAST Investigational Site

Adelaide, South Australia, 5000, Australia

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COAST Investigational Site

East Melbourne, Victoria, 3002, Australia

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COAST Investigational Site

Rowville, Victoria, 3178, Australia

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COAST Investigational Site

Graz, 8036, Austria

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COAST Investigational Site

Belo Horizonte, Minas Gerais, 30330-000, Brazil

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COAST Investigational Site

Porto Alegre, Rio Grande do Sul, 90410-000, Brazil

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COAST Investigational Site

São Paulo, 01427-002, Brazil

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COAST Investigational Site

São Paulo, 04038-032, Brazil

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COAST Investigational Site

São Paulo, 04084-002, Brazil

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COAST Investigational Site

Sofia, 1431, Bulgaria

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COAST Investigational Site

Stara Zagora, 6000, Bulgaria

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COAST Investigational Site

Brampton, Ontario, L6Y 0P6, Canada

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COAST Investigational Site

North York, Ontario, M3C 0GP, Canada

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COAST Investigational Site

Ottawa, Ontario, K1H 8L6, Canada

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COAST Investigational Site

Ottawa, Ontario, K2B7E9, Canada

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COAST Investigational Site

Medellín, Antioquia, 50016, Colombia

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COAST Investigational Site

Bogotá, Cundinamarca, 110121, Colombia

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COAST Investigational Site

Cali, Valle del Cauca Department, 760042, Colombia

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COAST Investigational Site

Barranquilla, 80002, Colombia

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COAST Investigational Site

Bogotá, 110231, Colombia

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COAST Investigational Site

Cali, 760036, Colombia

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COAST Investigational Site

Medellín, 5001, Colombia

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COAST Investigational Site

Osijek, 31000, Croatia

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COAST Investigational Site

Osijek, 3100, Croatia

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COAST Investigational Site

Split, 21000, Croatia

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COAST Investigational Site

Zagreb, 1000, Croatia

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COAST Investigational Site

Hradec Králové, Cech Republic, Czechia

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COAST Investigational Site

Brno, 625 00, Czechia

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COAST Investigational Site

Prague, 100 34, Czechia

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COAST Investigational Site

Prague, 12808, Czechia

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COAST Investigational Site

Prague, 15000, Czechia

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COAST Investigational Site

Praha 4-Krc, 140 59, Czechia

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COAST Investigational Site

Roskilde, 4000, Denmark

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COAST Investigational Site

Tallinn, 10138, Estonia

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COAST Investigational Site

Tallinn, 11314, Estonia

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COAST Investigational Site

Tallinn, 11412, Estonia

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COAST Investigational Site

Lyon, Rhone, 69004, France

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COAST Investigational Site

Poitiers, Vienne, 86021, France

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COAST Investigational Site

Dijon, 21079, France

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COAST Investigational Site

Paris, 75010, France

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COAST Investigational Site

Tübingen, Baden Wu, 72076, Germany

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COAST Investigational Site

Cologne, North Rhine-Westphalia, 50937, Germany

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COAST Investigational Site

Mainz, Rhineland-Palatinate, 55131, Germany

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COAST Investigational Site

Berlin, 12003, Germany

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COAST Investigational Site

Athens, 12462, Greece

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COAST Investigational Site

Heraklion, 71003, Greece

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COAST Investigational Site

Larissa, 41110, Greece

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COAST Investigational Site

Thessaloniki, 56403, Greece

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COAST Investigational Site

Budapest, 1068, Hungary

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COAST Investigational Site

Budapest, 1076, Hungary

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COAST Investigational Site

Budapest, 1085, Hungary

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COAST Investigational Site

Budapest, 1106, Hungary

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COAST Investigational Site

Budapest, 1115, Hungary

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COAST Investigational Site

Debrecen, 4032, Hungary

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COAST Investigational Site

Nyíregyháza, 4400, Hungary

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COAST Investigational Site

Pécs, 7621, Hungary

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COAST Investigational Site

Pécs, 7632, Hungary

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COAST Investigational Site

Zalaegerszeg, 8900, Hungary

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COAST Investigational Site

Hyderabad, Andhra Pradesh, 500034, India

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COAST Investigational Site

Ranchi, Jharkhand, 834001, India

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COAST Investigational Site

Mysore, Karnataka, 570001, India

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COAST Investigational Site

Nashik, Maharashtra, 422005, India

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COAST Investigational Site

Bhubaneswar, Odisha, 751024, India

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COAST Investigational Site

Madurai, Tamil Nadu, 625020, India

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COAST Investigational Site

Afula, 18101, Israel

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COAST Investigational Site

Haifa, 3434104, Israel

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COAST Investigational Site

Haifa, Israel

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COAST Investigational Site

Jerusalem, 9103102, Israel

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COAST Investigational Site

Jerusalem, 91120, Israel

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COAST Investigational Site

Rehovot, 7661041, Israel

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COAST Investigational Site

Tel Aviv, 6423906, Israel

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COAST Investigational Site

Ancona, Perugia, 6132, Italy

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COAST Investigational Site

Florence, 50134, Italy

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COAST Investigational Site

Milan, 20122, Italy

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COAST Investigational Site

Milan, 20132, Italy

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COAST Investigational Site

Milan, 20157, Italy

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COAST Investigational Site

Pisa, 56126, Italy

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COAST Investigational Site

Roma, 198, Italy

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COAST Investigational Site

Rome, 133, Italy

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COAST Investigational Site

Rozzano, 20089, Italy

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COAST Investigational Site

Riga, LV-1002, Latvia

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COAST Investigational Site

Riga, LV-1006, Latvia

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COAST Investigational Site

Kaunas, LT-50161, Lithuania

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COAST Investigational Site

Klaipėda, 92288, Lithuania

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COAST Investigational Site

Vilnius, LT-08661, Lithuania

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COAST Investigational Site

Nijmegen, 6525 EX, Netherlands

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COAST Investigational Site

Rotterdam, 3011 BH, Netherlands

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COAST Investigational Site

Tilburg, 5022 GC, Netherlands

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COAST Investigational Site

Santo Tomas, Batangas, 4234, Philippines

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COAST Investigational Site

Makati, 1209, Philippines

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COAST Investigational Site

Makati City, 1200, Philippines

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COAST Investigational Site

Pasig, 1604, Philippines

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COAST Investigational Site

Quezon City, 1112, Philippines

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COAST Investigational Site

Bielsko-Biala, 43-309, Poland

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COAST Investigational Site

Bydgoszcz, 85-631, Poland

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COAST Investigational Site

Bydgoszcz, 85-870, Poland

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COAST Investigational Site

Bytom, 41-902, Poland

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COAST Investigational Site

Lodz, 90-302, Poland

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COAST Investigational Site

Lublin, 20-064, Poland

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COAST Investigational Site

Olsztyn, 10-561, Poland

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COAST Investigational Site

Poznan, 60-538, Poland

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COAST Investigational Site

Arecibo, 612, Puerto Rico

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COAST Investigational Site

Bratislava, 821 01, Slovakia

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COAST Investigational Site

Trebišov, 075 01, Slovakia

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COAST Investigational Site

Trenčín, 91171, Slovakia

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COAST Investigational Site

Žilina, 012 07, Slovakia

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COAST Investigational Site

Seongnam-si, Gyeonggi-do, 13496, South Korea

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COAST Investigational Site

Suwon, Gyeonggi-do, 16499, South Korea

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COAST Investigational Site

Busan, 49241, South Korea

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COAST Investigational Site

Seoul, 2447, South Korea

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COAST Investigational Site

Seoul, 2841, South Korea

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COAST Investigational Site

Seoul, 6273, South Korea

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COAST Investigational Site

Seoul, 6351, South Korea

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COAST Investigational Site

Seoul, 7061, South Korea

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COAST Investigational Site

Soeul, 6198, South Korea

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COAST Investigational Site

Badalona, Barcelona, 8916, Spain

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COAST Investigational Site

Majadahonda, Madrid, 28222, Spain

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COAST Investigational Site

Oviedo, Principality of Asturias, 33012, Spain

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COAST Investigational Site

Barcelona, 8022, Spain

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COAST Investigational Site

Barcelona, 8035, Spain

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COAST Investigational Site

Barcelona, 8907, Spain

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COAST Investigational Site

Madrid, 28008, Spain

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COAST Investigational Site

Valencia, 46015, Spain

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COAST Investigational Site

Zaragoza, 500009, Spain

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COAST Investigational Site

Zaragoza, 50009, Spain

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COAST Investigational Site

Kaohsiung City, 333, Taiwan

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COAST Investigational Site

Kaohsiung City, 807, Taiwan

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COAST Investigational Site

Taichung, 404327, Taiwan

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COAST Investigational Site

Taipei, 111, Taiwan

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COAST Investigational Site

Taipei, 11217, Taiwan

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COAST Investigational Site

Taoyuan, 333, Taiwan

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COAST Investigational Site

Plymouth, Devon, PL6 5fp, United Kingdom

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COAST Investigational Site

Westcliff-on-Sea, Essex, SSO 0RY, United Kingdom

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COAST Investigational Site

Manchester, Greater Manchester, M13 9WL, United Kingdom

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COAST Investigational Site

Liverpool, Merseyside, L7 8XP, United Kingdom

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COAST Investigational Site

Gorleston-on-Sea, Norfolk, NR31 6LA, United Kingdom

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COAST Investigational Site

Frimley, Surrey, GU167UJ, United Kingdom

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COAST Investigational Site

Sunderland, Tyne and Wear, SR2 9HP, United Kingdom

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COAST Investigational Site

Leeds, West Yorkshire, LS9 7TF, United Kingdom

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COAST Investigational Site

London, EC1V 2PD, United Kingdom

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MeSH Terms

Conditions

Wet Macular Degeneration; Macular Degeneration; Eye Diseases; Retinal Diseases; Retinal Degeneration

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary

Limitations and Caveats

This study was terminated early by the Sponsor because the study did not meet the primary endpoint. Thus, not all participants in this study completed the full duration of treatment. Due to clinical program termination, data reported beyond the primary endpoint of Week 52 (safety analysis set) were not held to the expected standards for data verification and cleaning and are reported to the best of Sponsor's ability.

Results Point of Contact

• Title: Chief Officer
• Organization: Opthea Limited

info@opthea.com

+61 (0) 3 9826 0399

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 17, 2021
• Study Start: March 12, 2021
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: August 5, 2025
• Results First Posted: August 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

BU (2); PH (5); IL (7); KR (9); NL (3); ES (10); HU (10); US (60); CA (4); LA (2); FR (4); GB (9); SL (4); CZ (6); AR (6); DE (4); AU (1); DK (1); PL (8); BR (5); IT (9); CO (7); CR (4); GR (4); IN (6); LI (3); TW (6); PR (1)