A Dose Ranging Study of OPT-302 With Ranibizumab in Neovascular (Wet) AMD
NCT ID: NCT03345082
Last Updated: 2021-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
366 participants
INTERVENTIONAL
2017-11-06
2019-05-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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0.5 mg ranibizumab with 2.0 mg OPT-302
0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by 2.0 mg OPT-302 intravitreal injection (0.05 ml)
OPT-302
Intravitreal injection
ranibizumab
Intravitreal injection
0.5 mg ranibizumab with 0.5 mg OPT-302
0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by 0.5 mg OPT-302 intravitreal injection (0.05 ml)
OPT-302
Intravitreal injection
ranibizumab
Intravitreal injection
0.5 mg ranibizumab with sham
0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by sham
ranibizumab
Intravitreal injection
sham intravitreal injection
Sham (mock) intravitreal injection
Interventions
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OPT-302
Intravitreal injection
ranibizumab
Intravitreal injection
sham intravitreal injection
Sham (mock) intravitreal injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* An ETDRS BCVA score between 60 and 25 (inclusive) letters
Exclusion Criteria
* Clinically significant ocular disorders which may interfere with assessment of visual acuity, assessment of toxicity, or fundus photography in the Study Eye
* Poorly controlled diabetes mellitus (defined as HbA1c\>7%)
* Any clinically significant cardiovascular, renal or hepatic conditions, recent surgery, or malignancy, that would make the participant unsuitable for the study
50 Years
ALL
No
Sponsors
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Opthea Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Opthea Limited
Locations
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Opthea Investigational Site
Phoenix, Arizona, United States
Opthea Investigational Site
Phoenix, Arizona, United States
Opthea Investigational Site
Beverly Hills, California, United States
Opthea Investigational Site
Encino, California, United States
Opthea Investigational Site
Palm Desert, California, United States
Opthea Investigational Site
Redlands, California, United States
Opthea Study Site
Sacramento, California, United States
Opthea Investigational Site
Sacramento, California, United States
Opthea Investigational Site
San Diego, California, United States
Opthea Investigational Site
Santa Ana, California, United States
Opthea Investigational Site
Santa Barbara, California, United States
Opthea Investigational Site
Santa Maria, California, United States
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Colorado Springs, Colorado, United States
Opthea Investigational Site
Golden, Colorado, United States
Opthea Investigational Site
Boynton Beach, Florida, United States
Opthea Investigational Site
Fort Myers, Florida, United States
Opthea Investigational Site
Fort Myers, Florida, United States
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Melbourne, Florida, United States
Opthea Investigational Site
Pensacola, Florida, United States
Opthea Investigational Site
St. Petersburg, Florida, United States
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Tallahassee, Florida, United States
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Winter Haven, Florida, United States
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Augusta, Georgia, United States
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Shawnee Mission, Kansas, United States
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Wichita, Kansas, United States
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Paducah, Kentucky, United States
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Baltimore, Maryland, United States
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Grand Rapids, Michigan, United States
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Las Vegas, Nevada, United States
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Reno, Nevada, United States
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Edison, New Jersey, United States
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Teaneck, New Jersey, United States
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Albuquerque, New Mexico, United States
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Lynbrook, New York, United States
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Rochester, New York, United States
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Syracuse, New York, United States
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Asheville, North Carolina, United States
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Charlotte, North Carolina, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Portland, Oregon, United States
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Camp Hill, Pennsylvania, United States
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Kingston, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Ladson, South Carolina, United States
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West Columbia, South Carolina, United States
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Abilene, Texas, United States
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Austin, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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The Woodlands, Texas, United States
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Willow Park, Texas, United States
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Fairfax, Virginia, United States
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Virginia Beach, Virginia, United States
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Silverdale, Washington, United States
Opthea Investigational Site
Hradec Králové, , Czechia
Opthea Investigational Site
Prague, , Czechia
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Prague, , Czechia
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Créteil, , France
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Dijon, , France
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Écully, , France
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Paris, , France
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Paris, , France
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Strasbourg, , France
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Nyíregyháza, , Hungary
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Szeged, , Hungary
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Haifa, , Israel
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Haifa, , Israel
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Jerusalem, , Israel
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Jerusalem, , Israel
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Kfar Saba, , Israel
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Petah Tikva, , Israel
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Rehovot, , Israel
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Tel Aviv, , Israel
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Bologna, , Italy
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Florence, , Italy
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Milan, , Italy
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Milan, , Italy
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Roma, , Italy
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Jelgava, , Latvia
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Riga, , Latvia
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Riga, , Latvia
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Riga, , Latvia
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Bydgoszcz, , Poland
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Gdansk, , Poland
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Katowice, , Poland
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Krakow, , Poland
Opthea Investigationa Site
Lublin, , Poland
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Lublin, , Poland
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Wroclaw, , Poland
Opthea Investigational Site
Barcelona, , Spain
Opthea Investigational Site
Bilbao, , Spain
Opthea Investigational Site
Madrid, , Spain
Opthea Investigational Site
Oviedo, , Spain
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Pamplona, , Spain
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Santiago de Compostela, , Spain
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Valencia, , Spain
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Valladolid, , Spain
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Bristol, , United Kingdom
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Frimley, , United Kingdom
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Glasgow, , United Kingdom
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London, , United Kingdom
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Maidstone, , United Kingdom
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Sheffield, , United Kingdom
Opthea Investigational Site
Wolverhampton, , United Kingdom
Countries
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References
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Jackson TL, Slakter J, Buyse M, Wang K, Dugel PU, Wykoff CC, Boyer DS, Gerometta M, Baldwin ME, Price CF; Opthea Study Group Investigators. A Randomized Controlled Trial of OPT-302, a VEGF-C/D Inhibitor for Neovascular Age-Related Macular Degeneration. Ophthalmology. 2023 Jun;130(6):588-597. doi: 10.1016/j.ophtha.2023.02.001. Epub 2023 Feb 6.
Other Identifiers
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OPT-302-1002
Identifier Type: -
Identifier Source: org_study_id
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