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A multicentre, randomised, parallel group, sham-controlled, double-masked, dose-ranging study, investigating two doses of OPT-302 in combination with ranibizumab compared with ranibizumab with sham, over six consecutive monthly dosing cycles in participants with neovascular (wet) AMD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.5 mg ranibizumab with 2.0 mg OPT-302 | Experimental | 0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by 2.0 mg OPT-302 intravitreal injection (0.05 ml) |
|
| 0.5 mg ranibizumab with 0.5 mg OPT-302 | Experimental | 0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by 0.5 mg OPT-302 intravitreal injection (0.05 ml) |
|
| 0.5 mg ranibizumab with sham | Sham Comparator | 0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by sham |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OPT-302 | Biological | Intravitreal injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA) | Baseline to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants gaining 15 or more ETDRS BCVA letters | Baseline to Week 24 | |
| Area under the ETDRS BCVA over time curve | Baseline to Week 24 | |
| Change in central subfield thickness (CST) on spectral domain optical coherence tomography (SD-OCT) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Opthea Limited | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Opthea Investigational Site | Phoenix | Arizona | 85014 | United States | ||
| Opthea Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36754174 | Derived | 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. |
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| ranibizumab | Biological | Intravitreal injection |
|
|
| sham intravitreal injection | Other | Sham (mock) intravitreal injection |
|
| Baseline to Week 24 |
| Change in intra-retinal fluid and sub-retinal fluid on SD-OCT | Baseline to Week 24 |
| Proportion of participants losing 15 or more letters (on ETDRS BCVA chart) | Baseline to Week 24 |
| Phoenix |
| Arizona |
| 85020 |
| United States |
| Opthea Investigational Site | Beverly Hills | California | 90211 | United States |
| Opthea Investigational Site | Encino | California | 91436 | United States |
| Opthea Investigational Site | Palm Desert | California | 92260 | United States |
| Opthea Investigational Site | Redlands | California | 92374 | United States |
| Opthea Study Site | Sacramento | California | 95819 | United States |
| Opthea Investigational Site | Sacramento | California | 95841 | United States |
| Opthea Investigational Site | San Diego | California | 94143 | United States |
| Opthea Investigational Site | Santa Ana | California | 92705 | United States |
| Opthea Investigational Site | Santa Barbara | California | 93103 | United States |
| Opthea Investigational Site | Santa Maria | California | 93454 | United States |
| Opthea Investigational Site | Colorado Springs | Colorado | 80909 | United States |
| Opthea Investigational Site | Golden | Colorado | 80401 | United States |
| Opthea Investigational Site | Boynton Beach | Florida | 33426 | United States |
| Opthea Investigational Site | Fort Myers | Florida | 33907 | United States |
| Opthea Investigational Site | Fort Myers | Florida | 33912 | United States |
| Opthea Investigational Site | Melbourne | Florida | 32901 | United States |
| Opthea Investigational Site | Pensacola | Florida | 32503 | United States |
| Opthea Investigational Site | St. Petersburg | Florida | 33703 | United States |
| Opthea Investigational Site | Tallahassee | Florida | 32308 | United States |
| Opthea Investigational Site | Winter Haven | Florida | 33880 | United States |
| Opthea Investigational Site | Augusta | Georgia | 30909 | United States |
| Opthea Investigational Site | Shawnee Mission | Kansas | 66204 | United States |
| Opthea Investigational Site | Wichita | Kansas | 67214 | United States |
| Opthea Investigational Site | Paducah | Kentucky | 42001 | United States |
| Opthea Investigational Site | Baltimore | Maryland | 21204 | United States |
| Opthea Investigational Site | Grand Rapids | Michigan | 49546 | United States |
| Opthea Investigational Site | Las Vegas | Nevada | 89144 | United States |
| Opthea Investigational Site | Reno | Nevada | 89502 | United States |
| Opthea Investigational Site | Edison | New Jersey | 08820 | United States |
| Opthea Investigational Site | Teaneck | New Jersey | 07666 | United States |
| Opthea Investigational Site | Albuquerque | New Mexico | 87109 | United States |
| Opthea Investigational Site | Lynbrook | New York | 11563 | United States |
| Opthea Investigational Site | Rochester | New York | 14620 | United States |
| Opthea Investigational Site | Syracuse | New York | 13224 | United States |
| Opthea Investigational Site | Asheville | North Carolina | 28803 | United States |
| Opthea Investigational Site | Charlotte | North Carolina | 28210 | United States |
| Opthea Investigational Site | Cleveland | Ohio | 44195 | United States |
| Opthea Investigational Site | Columbus | Ohio | 43212 | United States |
| Opthea Investigational Site | Portland | Oregon | 97239 | United States |
| Opthea Investigational Site | Camp Hill | Pennsylvania | 17011 | United States |
| Opthea Investigational Site | Kingston | Pennsylvania | 18704 | United States |
| Opthea Investigational Site | Philadelphia | Pennsylvania | 19107 | United States |
| Opthea Investigational Site | Ladson | South Carolina | 29456 | United States |
| Opthea Investigational Site | West Columbia | South Carolina | 29169 | United States |
| Opthea Investigational Site | Abilene | Texas | 79606 | United States |
| Opthea Investigational Site | Austin | Texas | 78705 | United States |
| Opthea Investigational Site | Houston | Texas | 77030 | United States |
| Opthea Investigational Site | San Antonio | Texas | 78240 | United States |
| Opthea Investigational Site | The Woodlands | Texas | 77384 | United States |
| Opthea Investigational Site | Willow Park | Texas | 76087 | United States |
| Opthea Investigational Site | Fairfax | Virginia | 22031 | United States |
| Opthea Investigational Site | Virginia Beach | Virginia | 23462 | United States |
| Opthea Investigational Site | Silverdale | Washington | 98383 | United States |
| Opthea Investigational Site | Hradec Králové | 50005 | Czechia |
| Opthea Investigational Site | Prague | 10034 | Czechia |
| Opthea Investigational Site | Prague | 12808 | Czechia |
| Opthea Investigational Site | Créteil | 94010 | France |
| Opthea Investigational Site | Dijon | 21079 | France |
| Opthea Investigational Site | Écully | 69130 | France |
| Opthea Investigational Site | Paris | 75010 | France |
| Opthea Investigational Site | Paris | 75019 | France |
| Opthea Investigational Site | Strasbourg | 67090 | France |
| Opthea Investigational Site | Budapest | 1062 | Hungary |
| Opthea Investigational Site | Budapest | 1133 | Hungary |
| Opthea Investigational Site | Budapest | Hungary |
| Opthea Investigational Site | Nyíregyháza | Hungary |
| Opthea Investigational Site | Szeged | 6720 | Hungary |
| Opthea Investigational Site | Haifa | 31048 | Israel |
| Opthea Investigational Site | Haifa | Israel |
| Opthea Investigational Site | Jerusalem | 91031 | Israel |
| Opthea Investigational Site | Jerusalem | Israel |
| Opthea Investigational Site | Kfar Saba | Israel |
| Opthea Investigational Site | Petah Tikva | Israel |
| Opthea Investigational Site | Rehovot | Israel |
| Opthea Investigational Site | Tel Aviv | Israel |
| Opthea Investigational Site | Bologna | 40138 | Italy |
| Opthea Investigational Site | Florence | 50134 | Italy |
| Opthea Investigational Site | Milan | 20157 | Italy |
| Opthea Investigational Site | Milan | Italy |
| Opthea Investigational Site | Roma | 00133 | Italy |
| Opthea Investigational Site | Jelgava | Latvia |
| Opthea Investigational Site | Riga | 1006 | Latvia |
| Opthea Investigational Site | Riga | 1009 | Latvia |
| Opthea Investigational Site | Riga | Latvia |
| Opthea Investigational Site | Bydgoszcz | Poland |
| Opthea Investigational Site | Gdansk | Poland |
| Opthea Investigational Site | Katowice | Poland |
| Opthea Investigational Site | Krakow | Poland |
| Opthea Investigationa Site | Lublin | 20079 | Poland |
| Opthea Investigational Site | Lublin | Poland |
| Opthea Investigational Site | Wroclaw | Poland |
| Opthea Investigational Site | Barcelona | Spain |
| Opthea Investigational Site | Bilbao | Spain |
| Opthea Investigational Site | Madrid | Spain |
| Opthea Investigational Site | Oviedo | Spain |
| Opthea Investigational Site | Pamplona | Spain |
| Opthea Investigational Site | Santiago de Compostela | Spain |
| Opthea Investigational Site | Valencia | Spain |
| Opthea Investigational Site | Valladolid | Spain |
| Opthea Investigational Site | Bristol | United Kingdom |
| Opthea Investigational Site | Frimley | United Kingdom |
| Opthea Investigational Site | Glasgow | United Kingdom |
| Opthea Investigational Site | London | United Kingdom |
| Opthea Investigational Site | Maidstone | United Kingdom |
| Opthea Investigational Site | Sheffield | United Kingdom |
| Opthea Investigational Site | Wolverhampton | United Kingdom |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 26, 2025 | Jul 14, 2025 | 11 | ||
| Jul 17, 2025 | Aug 4, 2025 | 12 | ||
| Aug 15, 2025 | Aug 21, 2025 | 13 |
| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| C005703 | salicylhydroxamic acid |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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