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

NCT04757610 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: OPT-302-1004
• Study Type: interventional
• Target: 986
• Locations: 24 countries
• Sites: 191

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

Outcome Measures

Primary Outcomes (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)

  Baseline to Week 52

Secondary Outcomes (4)

• Participants Gaining 15 or More ETDRS BCVA Letters

  Baseline to Week 52

• Participants Gaining 10 More ETDRS BCVA Letters

  Baseline to Week 52

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

  Baseline to Week 52

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

  at Week 52

Study Arms (3)

0.5 mg ranibizumab with Standard Dosing 2.0 mg OPT-302

EXPERIMENTAL

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

Biological: 2.0 mg OPT-302; Biological: 0.5 mg ranibizumab

0.5 mg ranibizumab with Extended Dosing 2.0 mg OPT-302

EXPERIMENTAL

0.5 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.

Biological: 2.0 mg OPT-302; Biological: 0.5 mg ranibizumab

0.5 mg ranibizumab with sham

SHAM COMPARATOR

0.5 mg ranibizumab intravitreal injection administered at 4-weekly intervals. Sham intravitreal injection administered at 4-weekly intervals.

Biological: 0.5 mg ranibizumab; Procedure: Sham

Interventions

2.0 mg OPT-302 BIOLOGICAL

intravitreal injection

0.5 mg ranibizumab with Extended Dosing 2.0 mg OPT-302; 0.5 mg ranibizumab with Standard Dosing 2.0 mg OPT-302

0.5 mg ranibizumab BIOLOGICAL

intravitreal injection

0.5 mg ranibizumab with Extended Dosing 2.0 mg OPT-302; 0.5 mg ranibizumab with Standard Dosing 2.0 mg OPT-302; 0.5 mg ranibizumab with sham

Sham PROCEDURE

intravitreal injection

0.5 mg ranibizumab 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 (191)

ShORe Investigational Site

Phoenix, Arizona, 85016, United States

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ShORe Investigational Site

Phoenix, Arizona, 85050, United States

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Tucson, Arizona, 85704, United States

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Bakersfield, California, 93309, United States

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Campbell, California, 95008, United States

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Encino, California, 91436, United States

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Fullerton, California, 92835, United States

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Glendale, California, 91203, United States

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Huntington Beach, California, 92647, United States

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Laguna Hills, California, 92653, United States

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Long Beach, California, 90807, United States

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Los Angeles, California, 95817, United States

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Mountain View, California, 94040, United States

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Palm Desert, California, 92211, United States

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Pasadena, California, 91107, United States

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Poway, California, 92064, United States

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Redlands, California, 92373, United States

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Sacramento, California, 95817, United States

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Santa Ana, California, 92705, United States

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Torrance, California, 90503, United States

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Colorado Springs, Colorado, 80909, United States

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Denver, Colorado, 80206, United States

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Lakewood, Colorado, 80228, United States

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Longmont, Colorado, 80503, United States

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Clearwater, Florida, 33761, United States

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Fort Lauderdale, Florida, 33308, United States

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Fort Myers, Florida, 33912, United States

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Gainesville, Florida, 32607, United States

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Lakeland, Florida, 33805, United States

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Pensacola, Florida, 32503, United States

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Pinellas Park, Florida, 33782, United States

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Temple Terrace, Florida, 33617, United States

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Augusta, Georgia, 30909, United States

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Sandy Springs, Georgia, 30328, United States

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Lemont, Illinois, 60439, United States

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Indianapolis, Indiana, 46290, United States

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Baltimore, Maryland, 21209, United States

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Baltimore, Maryland, 21237, United States

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Hagerstown, Maryland, 21740, United States

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Towson, Maryland, 21204, United States

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Springfield, Massachusetts, 01107, United States

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Minneapolis, Minnesota, 55416, United States

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St Louis, Missouri, 63108, United States

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Reno, Nevada, 89502, United States

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Bloomfield, New Jersey, 07003, United States

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Toms River, New Jersey, 08755, United States

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Hauppauge, New York, 11021, United States

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Liverpool, New York, 13088, United States

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Wake Forest, North Carolina, 27587, United States

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Fargo, North Dakota, 58104, United States

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Edmond, Oklahoma, 73013, United States

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Tulsa, Oklahoma, 74114, United States

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Eugene, Oregon, 97401, United States

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Portland, Oregon, 97225, United States

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Portland, Oregon, 97239, United States

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Salem, Oregon, 97302, United States

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Erie, Pennsylvania, 16507, United States

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Beaufort, South Carolina, 29902, United States

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Ladson, South Carolina, 29456, United States

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Nashville, Tennessee, 37203, United States

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Arlington, Texas, 76012, United States

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Austin, Texas, 78705, United States

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Austin, Texas, 78731, United States

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Bellaire, Texas, 77401, United States

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Dallas, Texas, 75231, United States

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Houston, Texas, 77030, United States

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Katy, Texas, 77494, United States

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McAllen, Texas, 78503, United States

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San Antonio, Texas, 78240, United States

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San Antonio, Texas, 78251, United States

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San Antonio, Texas, 78340, United States

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Tyler, Texas, 75701, United States

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Willow Park, Texas, 76087, United States

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Salt Lake City, Utah, 84107, United States

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Charlottesville, Virginia, 22903, United States

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Lynchburg, Virginia, 24502, United States

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Capital Federal, Ciudad Autonoma Buenos Aires, C1120AAN, Argentina

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Rosario, Santa Fe Province, S2000ANJ, Argentina

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Rosario, Sante Fe, S2000DLA, Argentina

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Buenos Aires, 1832, Argentina

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Buenos Aires, B1629ODT, Argentina

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Ciudad Autonoma de Buenos Aire, C1015ABO, Argentina

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Córdoba, 5000, Argentina

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Hurstville, New South Wales, 2220, Australia

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Melbourne, Victoria, 3050, Australia

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Vitória, Cordoba, 5000, Brazil

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Goiânia, Goiás, 74210-01, Brazil

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

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Blumenau, Santa Catarina, 89052-504, Brazil

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Santo André, São Paulo, 09060-870, Brazil

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São Paulo, 1525, Brazil

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São Paulo, 18031-060, Brazil

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Sofia, 1407, Bulgaria

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Calgary, Alberta, T2A 0Z9, Canada

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Edmonton, Alberta, AB T5H 0X5, Canada

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Edmonton, Alberta, AB T5H OX5, Canada

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Mississauga, Ontario, L4W1W9, Canada

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Medellín, Colombia

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Pardubice, 53002, Czechia

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Prague, 10034, Czechia

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Prague, 15800, Czechia

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Sokolov, 356 01, Czechia

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Aarhus, 8200, Denmark

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Glostrup Municipality, 2600, Denmark

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Sønderborg, 6400, Denmark

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Nice, Alpes-Maritimes, 6000, France

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Strasbourg, Bas Rhin, 6700, France

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Écully, Rhone, 69130, France

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Créteil, Val de Marr, 94000, France

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Ulm, Baden Wuerttermberg, 89075, Germany

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Heidelberg, Baden-Wurttemberg, 69120, Germany

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Goettigen, Lower Saxony, 37075, Germany

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Düsseldorf, Nordrhein, 40225, Germany

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Münster, Nordrhein, 48145, Germany

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Bonn, North Rhine-Westphalia, 53127, Germany

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Münster, North Rhine-Westphalia, 48149, Germany

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Hamburg, 20246, Germany

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Athens, 11527, Greece

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Ioannina, 4550, Greece

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Pátrai, 26504, Greece

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Budapest, 1133, Hungary

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Miskolc, 3050, Hungary

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Szombathely, 9700, Hungary

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Ahmedabad, Gujarat, 380016, India

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Surat, Gujarat, 395001, India

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Bangalore, Karnataka, 560037, India

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Bangalore, Karnataka, 560094, India

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Pune, Maharashtra, 411060, India

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Chandigarh, Punjab, 160012, India

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Coimbatore, Tamil Nadu, 641035, India

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Lucknow, Uttar Pradesh, 226010, India

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Kolkata, West Bengal, 700073, India

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Mysuru, 570004, India

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Beersheba, 8410101, Israel

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Haifa, 3109601, Israel

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Kfar Saba, 4428164, Israel

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Petah Tikva, 4941492, Israel

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Rishon LeZiyyon, 70300, Israel

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Catanzaro, Reggio Calabria, 88100, Italy

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Bologna, 40138, Italy

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Chieti, 66100, Italy

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Genova, 16132, Italy

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Roma, 00168, Italy

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Siena, C1120AAN, Italy

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Udine, 33100, Italy

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Riga, LV-1002, Latvia

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Batu Caves, Selangor, 68100, Malaysia

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Shah Alam, Selangor, 4000, Malaysia

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Kuala Lumpur, 59200, Malaysia

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Gdansk, 80822, Poland

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Krakow, 31070, Poland

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Olsztyn, 10-424, Poland

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Szczecin, 70-111, Poland

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Tarnowskie Góry, 42-600, Poland

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Warsaw, 00631, Poland

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Wroclaw, 50-556, Poland

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Seongnam-si, Gyeonggi-do, 1360, South Korea

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Daegu, Gyeongsangbuk-do, 42415, South Korea

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Busan, 48108, South Korea

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Busan, 49201, South Korea

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Gwangju, 61469, South Korea

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Seoul, 3080, South Korea

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Seoul, 4401, South Korea

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Seoul, 5278, South Korea

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Seoul, 5505, South Korea

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Seoul, 7301, South Korea

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Seoul, 7441, South Korea

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Sant Cugat del Vallès, Barcelona, 8195, Spain

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Alcalá de Henares, Madrid, 28805, Spain

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Pamplona, Navarre, 31008, Spain

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Burjassot, Valencia, 46100, Spain

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Barcelona, 8023, Spain

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Barcelona, 8035, Spain

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Burgos, 9006, Spain

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Córdoba, 14012, Spain

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Madrid, 28035, Spain

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Madrid, 28040, Spain

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Valencia, 46015, Spain

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ShORe Investigational Site

Pathum Wan, Bangkok, 10330, Thailand

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Chiang Mai, 50200, Thailand

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Khon Kaen, 40002, Thailand

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Pathum Thani, 12121, Thailand

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Kiev, Ukraine

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Crewe, Cheshire, CW1 4QJ, United Kingdom

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Southampton, Hampshire, SO16 6YD, United Kingdom

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Leicester, Leicestershire, LE15 WW, United Kingdom

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Bristol, Somerset, BS12LX, United Kingdom

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Guildford, Surrey, GU27XX, United Kingdom

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Wolverhampton, West Midlands, WV10 0QP, United Kingdom

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London, SE59RS, United Kingdom

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London, W1G 7LB, United Kingdom

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MeSH Terms

Interventions

Ranibizumab; salicylhydroxamic acid

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

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 were not held to the expected standards for data verification and cleaning and are reported to the best of the 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: July 22, 2025
• Results First Posted: July 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (11); BR (7); CZ (4); UA (1); CA (4); CO (1); DE (8); GR (3); BU (1); DK (3); IL (5); IT (7); AR (7); LA (1); PL (7); TH (4); FR (4); HU (3); US (76); MY (3); ES (11); IN (10); GB (8); AU (2)