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

July 17, 2025 updated by: Opthea Limited

A Phase 3, Multicentre, Double-masked, Randomised Study to Evaluate the Efficacy and Safety of Intravitreal OPT-302 in Combination With Aflibercept, Compared With Aflibercept Alone, in Participants With nAMD

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

998

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Ciudad Autonoma de Buenos Aire, Argentina, C1023AAQ
        • COAST Investigational Site
      • Ciudad Autonoma de Buenos Aire, Argentina, C1061AAE
        • COAST Investigational Site
      • Ciudad Autonoma de Buenos Aire, Argentina, C1116ABA
        • COAST Investigational Site
      • Mendoza, Argentina, 5500
        • COAST Investigational Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000CTC
        • COAST Investigational Site
    • Sante Fe
      • Rosario, Sante Fe, Argentina, S2000DSK
        • COAST Investigational Site
  • Australia
    • New South Wales
      • Liverpool, New South Wales, Australia, 2127
        • COAST Investigational Site
      • Parramatta, New South Wales, Australia, 2150
        • COAST Investigational Site
      • Strathfield, New South Wales, Australia, 2135
        • COAST Investigational Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • COAST Investigational Site
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • COAST Investigational Site
      • Rowville, Victoria, Australia, 3178
        • COAST Investigational Site
  • Austria
      • Graz, Austria, 8036
        • COAST Investigational Site
  • Brazil
      • São Paulo, Brazil, 01427-002
        • COAST Investigational Site
      • São Paulo, Brazil, 04038-032
        • COAST Investigational Site
      • São Paulo, Brazil, 04084-002
        • COAST Investigational Site
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30330-000
        • COAST Investigational Site
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90410-000
        • COAST Investigational Site
  • Bulgaria
      • Sofia, Bulgaria, 1431
        • COAST Investigational Site
      • Stara Zagora, Bulgaria, 6000
        • COAST Investigational Site
  • Canada
    • Ontario
      • Brampton, Ontario, Canada, L6Y 0P6
        • COAST Investigational Site
      • North York, Ontario, Canada, M3C 0GP
        • COAST Investigational Site
      • Ottawa, Ontario, Canada, K1H 8L6
        • COAST Investigational Site
      • Ottawa, Ontario, Canada, K2B7E9
        • COAST Investigational Site
  • Colombia
      • Barranquilla, Colombia, 80002
        • COAST Investigational Site
      • Bogotá, Colombia, 110231
        • COAST Investigational Site
      • Cali, Colombia, 760036
        • COAST Investigational Site
      • Medellín, Colombia, 5001
        • COAST Investigational Site
    • Antioquia
      • Medellín, Antioquia, Colombia, 50016
        • COAST Investigational Site
    • Cundinamarca
      • Bogotá, Cundinamarca, Colombia, 110121
        • COAST Investigational Site
    • VAlle Del Cauca
      • Cali, VAlle Del Cauca, Colombia, 760042
        • COAST Investigational Site
  • Croatia
      • Osijek, Croatia, 31000
        • COAST Investigational Site
      • Osijek, Croatia, 3100
        • COAST Investigational Site
      • Split, Croatia, 21000
        • COAST Investigational Site
      • Zagreb, Croatia, 1000
        • COAST Investigational Site
  • Czechia
      • Brno, Czechia, 625 00
        • COAST Investigational Site
      • Praha, Czechia, 100 34
        • COAST Investigational Site
      • Praha, Czechia, 15000
        • COAST Investigational Site
      • Praha 2, Czechia, 12808
        • COAST Investigational Site
      • Praha 4-Krc, Czechia, 140 59
        • COAST Investigational Site
    • Cech Republic
      • Hradec Králové, Cech Republic, Czechia
        • COAST Investigational Site
  • Denmark
      • Roskilde, Denmark, 4000
        • COAST Investigational Site
  • Estonia
      • Tallinn, Estonia, 10138
        • COAST Investigational Site
      • Tallinn, Estonia, 11314
        • COAST Investigational Site
      • Tallinn, Estonia, 11412
        • COAST Investigational Site
  • France
      • Dijon, France, 21079
        • COAST Investigational Site
      • Paris, France, 75010
        • COAST Investigational Site
    • Rhone
      • Lyon, Rhone, France, 69004
        • COAST Investigational Site
    • Vienne
      • Poitiers, Vienne, France, 86021
        • COAST Investigational Site
  • Germany
      • Berlin, Germany, 12003
        • COAST Investigational Site
    • Baden Wu
      • Tuebingen, Baden Wu, Germany, 72076
        • COAST Investigational Site
    • Nordrhein Westfalen
      • Koeln, Nordrhein Westfalen, Germany, 50937
        • COAST Investigational Site
    • Rheinland Pfalz
      • Mainz, Rheinland Pfalz, Germany, 55131
        • COAST Investigational Site
  • Greece
      • Athens, Greece, 12462
        • COAST Investigational Site
      • Heraklion, Greece, 71003
        • COAST Investigational Site
      • Larissa, Greece, 41110
        • COAST Investigational Site
      • Thessaloníki, Greece, 56403
        • COAST Investigational Site
  • Hungary
      • Budapest, Hungary, 1068
        • COAST Investigational Site
      • Budapest, Hungary, 1076
        • COAST Investigational Site
      • Budapest, Hungary, 1085
        • COAST Investigational Site
      • Budapest, Hungary, 1106
        • COAST Investigational Site
      • Budapest, Hungary, 1115
        • COAST Investigational Site
      • Debrecen, Hungary, 4032
        • COAST Investigational Site
      • Nyiregyhaza, Hungary, 4400
        • COAST Investigational Site
      • Pécs, Hungary, 7621
        • COAST Investigational Site
      • Pécs, Hungary, 7632
        • COAST Investigational Site
      • Zalaegerszeg, Hungary, 8900
        • COAST Investigational Site
  • India
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500034
        • COAST Investigational Site
    • Jharkhand
      • Ranchi, Jharkhand, India, 834001
        • COAST Investigational Site
    • Karnataka
      • Mysore, Karnataka, India, 570001
        • COAST Investigational Site
    • Maharashtra
      • Nashik, Maharashtra, India, 422005
        • COAST Investigational Site
    • Orissa
      • Bhubaneswar, Orissa, India, 751024
        • COAST Investigational Site
    • Tamil Nadu
      • Madurai, Tamil Nadu, India, 625020
        • COAST Investigational Site
  • Israel
      • Afula, Israel, 18101
        • COAST Investigational Site
      • Haifa, Israel, 3434104
        • COAST Investigational Site
      • Haifa, Israel
        • COAST Investigational Site
      • Jerusalem, Israel, 9103102
        • COAST Investigational Site
      • Jerusalem, Israel, 91120
        • COAST Investigational Site
      • Reẖovot, Israel, 7661041
        • COAST Investigational Site
      • Tel Aviv, Israel, 6423906
        • COAST Investigational Site
  • Italy
      • Firenze, Italy, 50134
        • COAST Investigational Site
      • Milan, Italy, 20122
        • COAST Investigational Site
      • Milano, Italy, 20132
        • COAST Investigational Site
      • Milano, Italy, 20157
        • COAST Investigational Site
      • Pisa, Italy, 56126
        • COAST Investigational Site
      • Roma, Italy, 198
        • COAST Investigational Site
      • Rome, Italy, 133
        • COAST Investigational Site
      • Rozzano, Italy, 20089
        • COAST Investigational Site
    • Perugia
      • Ancona, Perugia, Italy, 6132
        • COAST Investigational Site
  • Korea, Republic of
      • Busan, Korea, Republic of, 49241
        • COAST Investigational Site
      • Seoul, Korea, Republic of, 2447
        • COAST Investigational Site
      • Seoul, Korea, Republic of, 2841
        • COAST Investigational Site
      • Seoul, Korea, Republic of, 6273
        • COAST Investigational Site
      • Seoul, Korea, Republic of, 6351
        • COAST Investigational Site
      • Seoul, Korea, Republic of, 7061
        • COAST Investigational Site
      • Soeul, Korea, Republic of, 6198
        • COAST Investigational Site
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13496
        • COAST Investigational Site
      • Suwon, Gyeonggi-do, Korea, Republic of, 16499
        • COAST Investigational Site
  • Latvia
      • Riga, Latvia, LV-1002
        • COAST Investigational Site
      • Riga, Latvia, LV-1006
        • COAST Investigational Site
  • Lithuania
      • Kaunas, Lithuania, LT-50161
        • COAST Investigational Site
      • Klaipėda, Lithuania, 92288
        • COAST Investigational Site
      • Vilnius, Lithuania, LT-08661
        • COAST Investigational Site
  • Netherlands
      • Nijmegen, Netherlands, 6525 EX
        • COAST Investigational Site
      • Rotterdam, Netherlands, 3011 BH
        • COAST Investigational Site
      • Tilburg, Netherlands, 5022 GC
        • COAST Investigational Site
  • Philippines
      • Makati, Philippines, 1209
        • COAST Investigational Site
      • Makati City, Philippines, 1200
        • COAST Investigational Site
      • Pasig City, Philippines, 1604
        • COAST Investigational Site
      • Quezon City, Philippines, 1112
        • COAST Investigational Site
    • Batangas
      • Santo Tomas, Batangas, Philippines, 4234
        • COAST Investigational Site
  • Poland
      • Bielsko-Biala, Poland, 43-309
        • COAST Investigational Site
      • Bydgoszcz, Poland, 85-631
        • COAST Investigational Site
      • Bydgoszcz, Poland, 85-870
        • COAST Investigational Site
      • Bytom, Poland, 41-902
        • COAST Investigational Site
      • Lublin, Poland, 20-064
        • COAST Investigational Site
      • Olsztyn, Poland, 10-561
        • COAST Investigational Site
      • Poznań, Poland, 60-538
        • COAST Investigational Site
      • Łódź, Poland, 90-302
        • COAST Investigational Site
  • Puerto Rico
      • Arecibo, Puerto Rico, 612
        • COAST Investigational Site
  • Slovakia
      • Bratislava, Slovakia, 821 01
        • COAST Investigational Site
      • Trebišov, Slovakia, 075 01
        • COAST Investigational Site
      • Trenčín, Slovakia, 91171
        • COAST Investigational Site
      • Žilina, Slovakia, 012 07
        • COAST Investigational Site
  • Spain
      • Barcelona, Spain, 8022
        • COAST Investigational Site
      • Barcelona, Spain, 8035
        • COAST Investigational Site
      • Barcelona, Spain, 8907
        • COAST Investigational Site
      • Madrid, Spain, 28008
        • COAST Investigational Site
      • Valencia, Spain, 46015
        • COAST Investigational Site
      • Zaragoza, Spain, 500009
        • COAST Investigational Site
      • Zaragoza, Spain, 50009
        • COAST Investigational Site
    • Asturias
      • Oviedo, Asturias, Spain, 33012
        • COAST Investigational Site
    • Barcelona
      • Badalona, Barcelona, Spain, 8916
        • COAST Investigational Site
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • COAST Investigational Site
  • Taiwan
      • Kaohsiung, Taiwan, 333
        • COAST Investigational Site
      • Kaohsiung, Taiwan, 807
        • COAST Investigational Site
      • Taichung, Taiwan, 404327
        • COAST Investigational Site
      • Taipei, Taiwan, 111
        • COAST Investigational Site
      • Taipei, Taiwan, 11217
        • COAST Investigational Site
      • Taoyuan City, Taiwan, 333
        • COAST Investigational Site
  • United Kingdom
      • London, United Kingdom, EC1V 2PD
        • COAST Investigational Site
    • Devon
      • Plymouth, Devon, United Kingdom, PL6 5fp
        • COAST Investigational Site
    • Essex
      • Westcliff-on-Sea, Essex, United Kingdom, SSO 0RY
        • COAST Investigational Site
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M13 9WL
        • COAST Investigational Site
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L7 8XP
        • COAST Investigational Site
    • Norfolk
      • Gorleston-on-Sea, Norfolk, United Kingdom, NR31 6LA
        • COAST Investigational Site
    • Surrey
      • Frimley, Surrey, United Kingdom, GU167UJ
        • COAST Investigational Site
    • Tyne And Wear
      • Sunderland, Tyne And Wear, United Kingdom, SR2 9HP
        • COAST Investigational Site
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS9 7TF
        • COAST Investigational Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85053
        • COAST Investigational Site
    • California
      • Arcadia, California, United States, 91006
        • COAST Investigational Site
      • Huntington Beach, California, United States, 92647
        • COAST Investigational Site
      • Redlands, California, United States, 92374
        • COAST Investigational Site
      • Sacramento, California, United States, 95841
        • COAST Investigational Site
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • COAST Investigational Site
    • Florida
      • Altamonte Springs, Florida, United States, 32750
        • COAST Investigational Site
      • Boynton Beach, Florida, United States, 33426
        • COAST Investigational Site
      • Coral Springs, Florida, United States, 33067
        • COAST Investigational Site
      • Melbourne, Florida, United States, 32901
        • COAST Investigational Site
      • Orlando, Florida, United States, 32806
        • COAST Investigational Site
      • Plantation, Florida, United States, 33324
        • COAST Investigational Site
      • Saint Petersburg, Florida, United States, 33711
        • COAST Investigational Site
      • Sarasota, Florida, United States, 34239
        • COAST Investigational Site
      • Stuart, Florida, United States, 34994
        • COAST Investigational Site
      • Winter Haven, Florida, United States, 33880
        • COAST Investigational Site
    • Georgia
      • Marietta, Georgia, United States, 30060
        • COAST Investigational Site
    • Hawaii
      • 'Aiea, Hawaii, United States, 96701
        • COAST Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • COAST Investigational Site
      • Springfield, Illinois, United States, 62704
        • COAST Investigational Site
      • Urbana, Illinois, United States, 61822
        • COAST Investigational Site
    • Indiana
      • New Albany, Indiana, United States, 47150
        • COAST Investigational Site
    • Kansas
      • Lenexa, Kansas, United States, 66215
        • COAST Investigational Site
      • Prairie Village, Kansas, United States, 66208
        • COAST Investigational Site
    • Louisiana
      • West Monroe, Louisiana, United States, 71291
        • COAST Investigational Site
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • COAST Investigational Site
      • Owings Mills, Maryland, United States, 21117
        • COAST Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • COAST Investigational Site
      • Worcester, Massachusetts, United States, 01605
        • COAST Investigational Site
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • COAST Investigational Site
    • Missouri
      • Independence, Missouri, United States, 64055
        • COAST Investigational Site
      • Saint Louis, Missouri, United States, 63128
        • COAST Investigational Site
    • New Jersey
      • Edison, New Jersey, United States, 08820
        • COAST Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • COAST Investigational Site
    • New York
      • Shirley, New York, United States, 11967
        • COAST Investigational Site
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • COAST Investigational Site
      • Wilmington, North Carolina, United States, 28401
        • COAST Investigational Site
      • Winston-Salem, North Carolina, United States, 27157
        • COAST Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45202
        • COAST Investigational Site
      • Dayton, Ohio, United States, 45459
        • COAST Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73102
        • COAST Investigational Site
    • Oregon
      • Springfield, Oregon, United States, 97477
        • COAST Investigational Site
    • Pennsylvania
      • Kingston, Pennsylvania, United States, 18704
        • COAST Investigational Site
      • Philadelphia, Pennsylvania, United States, 19107
        • COAST Investigational Site
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • COAST Investigational Site
      • West Columbia, South Carolina, United States, 29169
        • COAST Investigational Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • COAST Investigational Site
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • COAST Investigational Site
      • Knoxville, Tennessee, United States, 37922
        • COAST Investigational Site
    • Texas
      • Abilene, Texas, United States, 79606
        • COAST Investigational Site
      • Austin, Texas, United States, 78705
        • COAST Investigational Site
      • Burleson, Texas, United States, 76028
        • COAST Investigational Site
      • Conroe, Texas, United States, 77384
        • COAST Investigational Site
      • Dallas, Texas, United States, 75243
        • COAST Investigational Site
      • Plano, Texas, United States, 75075
        • COAST Investigational Site
      • Round Rock, Texas, United States, 78681
        • COAST Investigational Site
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • COAST Investigational Site
    • Washington
      • Bellevue, Washington, United States, 98004
        • COAST Investigational Site
      • Spokane, Washington, United States, 99204
        • COAST Investigational Site
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • COAST Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 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 apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2.0 mg aflibercept with Standard Dosing 2.0 mg OPT-302

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
intravitreal injection
Biological: 2.0 aflibercept
intravitreal injection
Experimental: 2.0 mg aflibercept with Extended Dosing 2.0 mg OPT-302

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
intravitreal injection
Biological: 2.0 aflibercept
intravitreal injection
Sham Comparator: 2.0 mg aflibercept with sham

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.
Procedure: Sham
intravitreal injection
Biological: 2.0 aflibercept
intravitreal injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change in Early Treatment Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letters
Time Frame: Baseline to Week 52
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants Gaining 15 or More ETDRS BCVA Letters
Time Frame: Baseline to Week 52
To determine the effects of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 2.0 mg aflibercept, in participants with neovascular age-related macular degeneration (nAMD), in terms of proportion of participants gaining 15 or more letters in ETDRS BCVA in the study eye from Baseline to Week 52. The secondary analysis presented used multiple imputation analysis assuming missing at random in the overall population.
Baseline to Week 52
Proportion of Participants Gaining 10 or More ETDRS BCVA Letters
Time Frame: Baseline to Week 52
To determine the effects of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 2.0 mg aflibercept, in participants with neovascular age-related macular degeneration (nAMD), in terms of proportion of participants gaining 10 or more letters in ETDRS BCVA in the study eye from Baseline to Week 52. The secondary analysis presented used multiple imputation analysis assuming missing at random in the overall population.
Baseline to Week 52
Change in Choroidal Neovascularisation (CNV) Area by Fluorescein Angiography (FA)
Time Frame: Baseline to Week 52
To determine the effects of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 2.0 mg aflibercept, in participants with neovascular age-related macular degeneration (nAMD), in terms of change in CNV area as measured by FA in the study eye from Baseline to Week 52. The secondary analysis presented used mixed model for repeated measures in the overall population.
Baseline to Week 52
Proportion of Participants With Absence of Both Sub-retinal Fluid and Intra-retinal Cysts by SD-OCT
Time Frame: at Week 52
To determine the effects of intravitreal 2.0 mg OPT-302 when administered in combination with intravitreal 2.0 mg aflibercept, in participants with neovascular age-related macular degeneration (nAMD), in terms of proportion of participants with absence of both sub-retinal fluid and intra-retinal cysts by SD-OCT in the study eye at Week 52. The secondary analysis presented used multiple imputation analysis assuming missing at random in the overall population.
at Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Opthea Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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)

August 5, 2025

Last Update Submitted That Met QC Criteria

July 17, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OPT-302-1005

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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