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This research study will examine the safety and effectiveness of ONS-5010 in participants with AMD. The goal is to prevent vision loss by evaluating the effectiveness of ONS-5010 as compared with ranibizumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bevacizumab | Experimental | ONS-5010 |
|
| ranibizumab | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab | Biological | 1.25 mg, intravitreal injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects who gain 15 or more letters in best corrected visual acuity (BCVA) | BCVA to be assessed as letters read using the Early Treatment Diabetic Retinopathy Study (ETDRS) charts. A positive change represents an improvement in visual acuity. | Baseline, 11 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in the best corrected visual acuity | BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity. | Baseline, monthly to 11 months |
| Proportion of participants who gain at least 10 letters in the best corrected visual acuity |
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Inclusion Criteria:
Active primary Subfoveal Choroidal Neovascularization lesions secondary to Age-related macular degeneration (AMD) in the study eye
Best corrected visual acuity of 25-67 letters read (20/50 to 20/320 Snellen equivalent)
Study eye must:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer M Kissner, PhD | Outlook Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Site | Tucson | Arizona | 85710 | United States | ||
| Clinical Site |
Data will not be shared until all global regulatory filings are complete.
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| ranibizumab | Biological | 0.5mg, intravitreal injection |
|
BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity. |
| Baseline, 11 months |
| Proportion of participants who gain at least 5 letters in the best corrected visual acuity | BCVA to be assessed as letters read using the ETDRS charts. A positive change represents an improvement in visual acuity. | Baseline, 11 months |
| Proportion of participants who lose fewer than 15 letters in the best corrected visual acuity | BCVA to be assessed as letters read using the ETDRS charts. A negative change represents a decrease in visual acuity. | Baseline, 11 months |
| Proportion of participants with visual-acuity Snellen equivalent of 20/200 or worse | Baseline, 11 months |
| Percentage of participants with ocular adverse events, non-ocular adverse events, grade 3 and above laboratory abnormalities, and vital sign abnormalities | 11 months, 12 months |
| Arcadia |
| California |
| 91007 |
| United States |
| Clinical Site | Beverly Hills | California | 90211 | United States |
| Clinical Site | Campbell | California | 95008 | United States |
| Clinical Site | Glendale | California | 91203 | United States |
| Clinical Site | Laguna Hills | California | 92653 | United States |
| Clinical Site | Long Beach | California | 90807 | United States |
| Clinical Site | Mountain View | California | 94040 | United States |
| Clinical Site | Oxnard | California | 93036 | United States |
| Clinical Site | Palm Desert | California | 92260 | United States |
| Clinical Site | Poway | California | 92064 | United States |
| Clinical Site | Sacramento | California | 95841 | United States |
| Clinical Site | Santa Maria | California | 93454 | United States |
| Clinical Site | Tustin | California | 92780 | United States |
| Clinical Site | Golden | Colorado | 80401 | United States |
| Clinical Site | Hamden | Connecticut | 06518 | United States |
| Clinical Site | Clearwater | Florida | 33761 | United States |
| Clinical Site | Pinellas Park | Florida | 33782 | United States |
| Clinical Site | Sarasota | Florida | 24233 | United States |
| Clinical Site | Winter Haven | Florida | 33880 | United States |
| Clinical Site | Augusta | Georgia | 30909 | United States |
| Clinical Site | Marietta | Georgia | 30060 | United States |
| Clinical Site | Downers Grove | Illinois | 60615 | United States |
| Clinical Site | Lemont | Illinois | 60439 | United States |
| Clinical Site | Springfield | Illinois | 62704 | United States |
| Clinical Site | Indianapolis | Indiana | 46290 | United States |
| Clinical Site | Hagerstown | Maryland | 21740 | United States |
| Clinical Site | Edina | Minnesota | 55435 | United States |
| Clinical Site | St Louis | Missouri | 63144 | United States |
| Clinical Site | Bloomfield | New Jersey | 07003 | United States |
| Clinical Site | Albuquerque | New Mexico | 87109 | United States |
| Clinical Site | New York | New York | 10021 | United States |
| Clinical Site | Chambersburg | Pennsylvania | 17201 | United States |
| Clinical Site | Monroeville | Pennsylvania | 15146 | United States |
| Clinical Site | Rapid City | South Dakota | 57701 | United States |
| Clinical Site | Germantown | Tennessee | 38138 | United States |
| Clinical Site | Abilene | Texas | 79606 | United States |
| Clinical Site | Amarillo | Texas | 79106 | United States |
| Clinical Site | Arlington | Texas | 76012 | United States |
| Clinical Site | Dallas | Texas | 75231 | United States |
| Clinical Site | Grapevine | Texas | 76051 | United States |
| Clinical Site | Houston | Texas | 77030 | United States |
| Clinical Site | McAllen | Texas | 78503 | United States |
| Clinical Site | San Antonio | Texas | 78240 | United States |
| Clinical Site | San Antonio | Texas | 78251 | United States |
| Clinical Site | The Woodlands | Texas | 77384 | United States |
| Clinical Site | Willow Park | Texas | 76807 | United States |
| Clinical Site | Salt Lake City | Utah | 84107 | United States |
| Clinical Site | Norfolk | Virginia | 23502 | United States |
| Clinical Site | Madison | Wisconsin | 53705 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 2, 2026 | Jun 25, 2026 | 36 | ||
| Jul 8, 2026 |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D057135 | Wet Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000069579 | Ranibizumab |
| 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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