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

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.

Study Overview

• Status: Terminated
• Conditions: Neovascular Age-related Macular Degeneration
• Intervention / Treatment: Biological: 2.0 mg OPT-302; Biological: 0.5 mg ranibizumab; Procedure: Sham

• Study Type: Interventional
• Enrollment (Actual): 986
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 1832
    • ShORe Investigational Site
  • Buenos Aires, Argentina, B1629ODT
    • ShORe Investigational Site
  • Ciudad Autonoma de Buenos Aire, Argentina, C1015ABO
    • ShORe Investigational Site
  • Córdoba, Argentina, 5000
    • ShORe Investigational Site
  • Ciudad Autonoma Buenos Aires
    • Capital federal, Ciudad Autonoma Buenos Aires, Argentina, C1120AAN
      • ShORe Investigational Site
  • Santa Fe
    • Rosario, Santa Fe, Argentina, S2000ANJ
      • ShORe Investigational Site
  • Sante Fe
    • Rosario, Sante Fe, Argentina, S2000DLA
      • ShORe Investigational Site
• Australia
  • New South Wales
    • Hurstville, New South Wales, Australia, 2220
      • ShORe Investigational Site
  • Victoria
    • Melbourne, Victoria, Australia, 3050
      • ShORe Investigational Site
• Brazil
  • São Paulo, Brazil, 1525
    • ShORe Investigational Site
  • São Paulo, Brazil, 18031-060
    • ShORe Investigational Site
  • Cordoba
    • Vitória, Cordoba, Brazil, 5000
      • ShORe Investigational Site
  • Goias
    • Goiânia, Goias, Brazil, 74210-01
      • ShORe Investigational Site
  • Rio Grande Do Sul
    • Faxinal do Soturno, Rio Grande Do Sul, Brazil, 97220-000
      • ShORe Investigational Site
  • Santa Catarina
    • Blumenau, Santa Catarina, Brazil, 89052-504
      • ShORe Investigational Site
  • Sao Paulo
    • Santo André, Sao Paulo, Brazil, 09060-870
      • ShORe Investigational Site
• Bulgaria
  • Sofia, Bulgaria, 1407
    • ShORe Investigational Site
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2A 0Z9
      • ShORe Investigational Site
    • Edmonton, Alberta, Canada, AB T5H 0X5
      • ShORe Investigational Site
    • Edmonton, Alberta, Canada, AB T5H OX5
      • ShORe Investigational Site
  • Ontario
    • Mississauga, Ontario, Canada, L4W1W9
      • ShORe Investigational Site
• Colombia
  • Medellín, Colombia
    • ShORe Investigational Site
• Czechia
  • Pardubice, Czechia, 53002
    • ShORe Investigational Site
  • Praha, Czechia, 10034
    • ShORe Investigational Site
  • Praha, Czechia, 15800
    • ShORe Investigational Site
  • Sokolov, Czechia, 356 01
    • ShORe Investigational Site
• Denmark
  • Aarhus, Denmark, 8200
    • ShORe Investigational Site
  • Glostrup, Denmark, 2600
    • ShORe Investigational Site
  • Sønderborg, Denmark, 6400
    • ShORe Investigational Site
• France
  • Alpes-Maritimes
    • Nice, Alpes-Maritimes, France, 6000
      • ShORe Investigational Site
  • Bas Rhin
    • Strasbourg, Bas Rhin, France, 6700
      • ShORe Investigational Site
  • Rhone
    • Écully, Rhone, France, 69130
      • ShORe Investigational Site
  • Val De Marr
    • Créteil, Val De Marr, France, 94000
      • ShORe Investigational Site
• Germany
  • Hamburg, Germany, 20246
    • ShORe Investigational Site
  • Baden Wuerttemberg
    • Heidelberg, Baden Wuerttemberg, Germany, 69120
      • ShORe Investigational Site
  • Baden Wuerttermberg
    • Ulm, Baden Wuerttermberg, Germany, 89075
      • ShORe Investigational Site
  • Niedersachsen
    • Goettigen, Niedersachsen, Germany, 37075
      • ShORe Investigational Site
  • Nordrhein
    • Düsseldorf, Nordrhein, Germany, 40225
      • ShORe Investigational Site
    • Münster, Nordrhein, Germany, 48145
      • ShORe Investigational Site
  • Nordrhein Westfalen
    • Bonn, Nordrhein Westfalen, Germany, 53127
      • ShORe Investigational Site
    • Münster, Nordrhein Westfalen, Germany, 48149
      • ShORe Investigational Site
• Greece
  • Athens, Greece, 11527
    • ShORe Investigational Site
  • Ioánnina, Greece, 4550
    • ShORe Investigational Site
  • Patra, Greece, 26504
    • ShORe Investigational Site
• Hungary
  • Budapest, Hungary, 1133
    • ShORe Investigational Site
  • Miskolc, Hungary, 3050
    • ShORe Investigational Site
  • Szombathely, Hungary, 9700
    • ShORe Investigational Site
• India
  • Mysuru, India, 570004
    • ShORe Investigational Site
  • Gujarat
    • Ahmedabad, Gujarat, India, 380016
      • ShORe Investigational Site
    • Sūrat, Gujarat, India, 395001
      • ShORe Investigational Site
  • Karnataka
    • Bangalore, Karnataka, India, 560037
      • ShORe Investigational Site
    • Bangalore, Karnataka, India, 560094
      • ShORe Investigational Site
  • Maharashtra
    • Pune, Maharashtra, India, 411060
      • ShORe Investigational Site
  • Punjab
    • Chandigarh, Punjab, India, 160012
      • ShORe Investigational Site
  • Tamilnadu
    • Coimbatore, Tamilnadu, India, 641035
      • ShORe Investigational Site
  • Uttar Pradesh
    • Lucknow, Uttar Pradesh, India, 226010
      • ShORe Investigational Site
  • West Bengal
    • Kolkata, West Bengal, India, 700073
      • ShORe Investigational Site
• Israel
  • Be'er Sheva, Israel, 8410101
    • ShORe Investigational Site
  • Haifa, Israel, 3109601
    • ShORe Investigational Site
  • Kfar-Sava, Israel, 4428164
    • ShORe Investigational Site
  • Petach Tikva, Israel, 4941492
    • ShORe Investigational Site
  • Rishon LeZion, Israel, 70300
    • ShORe Investigational Site
• Italy
  • Bologna, Italy, 40138
    • ShORe Investigational Site
  • Chieti, Italy, 66100
    • ShORe Investigational Site
  • Genova, Italy, 16132
    • ShORe Investiagational Site
  • Roma, Italy, 00168
    • ShORe Investigational Site
  • Siena, Italy, C1120AAN
    • ShORe Investigational Site
  • Udine, Italy, 33100
    • ShORe Investigational Site
  • Reggio Calabria
    • Catanzaro, Reggio Calabria, Italy, 88100
      • ShORe Investigational Site
• Korea, Republic of
  • Busan, Korea, Republic of, 48108
    • ShORe Investigational Site
  • Busan, Korea, Republic of, 49201
    • ShORe Investigational Site
  • Gwangju, Korea, Republic of, 61469
    • ShORe Investigational Site
  • Seoul, Korea, Republic of, 3080
    • ShORe Investigational Site
  • Seoul, Korea, Republic of, 4401
    • ShORe Investigational Site
  • Seoul, Korea, Republic of, 5278
    • ShORe Investigational Site
  • Seoul, Korea, Republic of, 5505
    • ShORe Investigational Site
  • Seoul, Korea, Republic of, 7301
    • ShORe Investigational Site
  • Seoul, Korea, Republic of, 7441
    • ShORe Investigational Site
  • Gyeonggi-do
    • Seongnam, Gyeonggi-do, Korea, Republic of, 1360
      • ShORe Investigational Site
  • Gyeongsangbuk-do
    • Daegu, Gyeongsangbuk-do, Korea, Republic of, 42415
      • ShORe Investigational Site
• Latvia
  • Riga, Latvia, LV-1002
    • ShORe Investigational Site
• Malaysia
  • Kuala Lumpur, Malaysia, 59200
    • ShORe Investigational Site
  • Selangor
    • Batu Caves, Selangor, Malaysia, 68100
      • ShORe Investigational Site
    • Shah Alam, Selangor, Malaysia, 4000
      • ShORe Investigational Site
• Poland
  • Gdańsk, Poland, 80822
    • ShORe Investigational Site
  • Kraków, Poland, 31070
    • ShORe Investigational Site
  • Olsztyn, Poland, 10-424
    • ShORe Investigational Site
  • Szczecin, Poland, 70-111
    • ShORe Investigational Site
  • Tarnowskie Góry, Poland, 42-600
    • ShORe Investigational Site
  • Warsaw, Poland, 00631
    • ShORe Investigational Site
  • Wroclaw, Poland, 50-556
    • ShORe Investigational Site
• Spain
  • Barcelona, Spain, 8023
    • ShORe Investigational Site
  • Barcelona, Spain, 8035
    • ShORe Investigational Site
  • Burgos, Spain, 9006
    • ShORe Investigational Site
  • Córdoba, Spain, 14012
    • ShORe Investigational Site
  • Madrid, Spain, 28035
    • ShORe Investigational Site
  • Madrid, Spain, 28040
    • ShORe Investigational Site
  • Valencia, Spain, 46015
    • ShORe Investigational Site
  • Barcelona
    • Sant Cugat Del Vallès, Barcelona, Spain, 8195
      • ShORe Investigational Site
  • Madrid
    • Alcala de Henares, Madrid, Spain, 28805
      • ShORe Investigational Site
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • ShORe Investigational Site
  • Valencia
    • Burjassot, Valencia, Spain, 46100
      • ShORe Investigational Site
• Thailand
  • Chiang Mai, Thailand, 50200
    • ShORe Investigational Site
  • Khon Kaen, Thailand, 40002
    • ShORe Investigational Site
  • Pathum Thani, Thailand, 12121
    • ShORe Investigational Site
  • Bangkok
    • Pathum Wan, Bangkok, Thailand, 10330
      • ShORe Investigational Site
• Ukraine
  • Kiev, Ukraine
    • ShORe Investigational Site
• United Kingdom
  • London, United Kingdom, SE59RS
    • ShORe Investigational Site
  • London, United Kingdom, W1G 7LB
    • ShORe Investigational Site
  • Cheshire
    • Crewe, Cheshire, United Kingdom, CW1 4QJ
      • ShORe Investigational Site
  • Hampshire
    • Southampton, Hampshire, United Kingdom, SO16 6YD
      • ShORe Investigational Site
  • Leicestershire
    • Leicester, Leicestershire, United Kingdom, LE15 WW
      • ShORe Investigational Site
  • Somerset
    • Bristol, Somerset, United Kingdom, BS12LX
      • ShORe Investigational Site
  • Surrey
    • Guildford, Surrey, United Kingdom, GU27XX
      • ShORe Investigational Site
  • West Midlands
    • Wolverhampton, West Midlands, United Kingdom, WV10 0QP
      • ShORe Investigational Site
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • ShORe Investigational Site
    • Phoenix, Arizona, United States, 85050
      • ShORe Investigational Site
    • Tucson, Arizona, United States, 85704
      • ShORe Investigational Site
  • California
    • Bakersfield, California, United States, 93309
      • ShORe Investigational Site
    • Campbell, California, United States, 95008
      • ShORe Investigational Site
    • Encino, California, United States, 91436
      • ShORe Investigational Site
    • Fullerton, California, United States, 92835
      • ShORe Investigational Site
    • Glendale, California, United States, 91203
      • ShORe Investigational Site
    • Huntington Beach, California, United States, 92647
      • ShORe Investigational Site
    • Laguna Hills, California, United States, 92653
      • ShORe Investigational Site
    • Long Beach, California, United States, 90807
      • ShORe Investigational Site
    • Los Angeles, California, United States, 95817
      • ShORe Investigational Site
    • Mountain View, California, United States, 94040
      • ShORe Investigational Site
    • Palm Desert, California, United States, 92211
      • ShORe Investigational Site
    • Pasadena, California, United States, 91107
      • ShORe Investigational Site
    • Poway, California, United States, 92064
      • ShORe Investiagtional Site
    • Redlands, California, United States, 92373
      • ShORe Investigational Site
    • Sacramento, California, United States, 95817
      • ShORe Investigational Site
    • Santa Ana, California, United States, 92705
      • ShORe Investigational Site
    • Torrance, California, United States, 90503
      • ShORe Investigational Site
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • ShORe Investigational Site
    • Denver, Colorado, United States, 80206
      • ShORe Investigational Site
    • Lakewood, Colorado, United States, 80228
      • ShORe Investigational Site
    • Longmont, Colorado, United States, 80503
      • ShORe Investigational Site
  • Florida
    • Clearwater, Florida, United States, 33761
      • ShORe Investigational Site
    • Fort Lauderdale, Florida, United States, 33308
      • ShORe Investigational Site
    • Fort Myers, Florida, United States, 33912
      • ShORe Investigational Site
    • Gainesville, Florida, United States, 32607
      • ShORe Investigational Site
    • Lakeland, Florida, United States, 33805
      • ShORe Investigational Site
    • Pensacola, Florida, United States, 32503
      • ShORe Investigational Site
    • Pinellas Park, Florida, United States, 33782
      • ShORe Investigational Site
    • Temple Terrace, Florida, United States, 33617
      • ShORe Investigational Site
  • Georgia
    • Augusta, Georgia, United States, 30909
      • ShORe Investigational Site
    • Sandy Springs, Georgia, United States, 30328
      • ShORe Investigational Site
  • Illinois
    • Lemont, Illinois, United States, 60439
      • ShORe Investigational Site
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • ShORe Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21209
      • ShORe Investigational Site
    • Baltimore, Maryland, United States, 21237
      • ShORe Investigational Site
    • Hagerstown, Maryland, United States, 21740
      • ShORe Investigational Site
    • Towson, Maryland, United States, 21204
      • ShORe Investigational Site
  • Massachusetts
    • Springfield, Massachusetts, United States, 01107
      • ShORe Investigational Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55416
      • ShORe Investigational Site
  • Missouri
    • Saint Louis, Missouri, United States, 63108
      • ShORe Investigational Site
  • Nevada
    • Reno, Nevada, United States, 89502
      • ShORe Investigational Site
  • New Jersey
    • Bloomfield, New Jersey, United States, 07003
      • ShORe Investigational Site
    • Toms River, New Jersey, United States, 08755
      • ShORe Investigational Site
  • New York
    • Hauppauge, New York, United States, 11021
      • ShORe Investigational Site
    • Liverpool, New York, United States, 13088
      • ShORe Investigational Site
  • North Carolina
    • Wake Forest, North Carolina, United States, 27587
      • ShORe Investigational Site
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • ShORe Investigational Site
  • Oklahoma
    • Edmond, Oklahoma, United States, 73013
      • ShORe Investigational Site
    • Tulsa, Oklahoma, United States, 74114
      • ShORe Investigational Site
  • Oregon
    • Eugene, Oregon, United States, 97401
      • ShORe Investigational Site
    • Portland, Oregon, United States, 97225
      • ShORe Investigational Site
    • Portland, Oregon, United States, 97239
      • ShORe Investigational Site
    • Salem, Oregon, United States, 97302
      • ShORe Investigational Site
  • Pennsylvania
    • Erie, Pennsylvania, United States, 16507
      • ShORe Investigational Site
  • South Carolina
    • Beaufort, South Carolina, United States, 29902
      • ShORe Investigational Site
    • Ladson, South Carolina, United States, 29456
      • ShORe Investigational Site
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • ShORe Investigational Site
  • Texas
    • Arlington, Texas, United States, 76012
      • ShORe Investigational Site
    • Austin, Texas, United States, 78705
      • ShORe Investigational Site
    • Austin, Texas, United States, 78731
      • ShORe Investigational Site
    • Bellaire, Texas, United States, 77401
      • ShORe Investigational Site
    • Dallas, Texas, United States, 75231
      • ShORe Investigational Site
    • Houston, Texas, United States, 77030
      • ShORe Investigational Site
    • Katy, Texas, United States, 77494
      • ShORe Investigational Site
    • McAllen, Texas, United States, 78503
      • ShORe Investigational Site
    • San Antonio, Texas, United States, 78240
      • ShORe Investigational Site
    • San Antonio, Texas, United States, 78251
      • ShORe Investigational Site
    • San Antonio, Texas, United States, 78340
      • ShORe Investigational Site
    • Tyler, Texas, United States, 75701
      • ShORe Investigational Site
    • Willow Park, Texas, United States, 76087
      • ShORe Investigational Site
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • ShORe Investigational Site
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • ShORe Investigational Site
    • Lynchburg, Virginia, United States, 24502
      • ShORe Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Active subfoveal CNV lesion or juxtafoveal CNV lesion with foveal involvement that is secondary to AMD in the Study Eye.
• An ETDRS BCVA score between 60 and 25 (inclusive) letters in the Study Eye.

Main 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0.5 mg ranibizumab with Standard Dosing 2.0 mg OPT-302; 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; intravitreal injection; Biological: 0.5 mg ranibizumab; intravitreal injection
Experimental: 0.5 mg ranibizumab with Extended Dosing 2.0 mg OPT-302; 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; intravitreal injection; Biological: 0.5 mg ranibizumab; intravitreal injection
Sham Comparator: 0.5 mg ranibizumab with sham; 0.5 mg ranibizumab intravitreal injection administered at 4-weekly intervals. Sham intravitreal injection administered at 4-weekly intervals.	Biological: 0.5 mg ranibizumab; intravitreal injection; Procedure: Sham; intravitreal injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to Week 52
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.	Baseline to Week 52
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.	Baseline to Week 52
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.	at Week 52

Collaborators and Investigators

• Sponsor: Opthea Limited

Publications and helpful links

Helpful Links

• Check your eligibility for this study and nearest site location

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2021
• Primary Completion (Actual): March 31, 2025
• Study Completion (Actual): March 31, 2025

Study Registration Dates

• First Submitted: February 12, 2021
• First Submitted That Met QC Criteria: February 15, 2021
• First Posted (Actual): February 17, 2021

Study Record Updates

• Last Update Posted (Actual): July 22, 2025
• Last Update Submitted That Met QC Criteria: July 17, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Degeneration; Macular Degeneration; Wet Macular Degeneration; Antineoplastic Agents; Physiological Effects of Drugs; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Ranibizumab
• Other Study ID Numbers: OPT-302-1004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No