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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 the best corrected visual acuity (BCVA) score | 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 over time | 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 score |
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Inclusion Criteria:
Active primary or recurrent Subfoveal Choroidal Neovascularization lesions secondary to Age-related macular degeneration (AMD) in the study eye
Best corrected visual acuity of 20/40 to 20/320
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 | Hurstville | New South Wales | Australia | |||
| 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 score | 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 score | 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 |
| Liverpool |
| New South Wales |
| Australia |
| Clinical Site | Sydney | New South Wales | Australia |
| Clinical Site | Westmead | New South Wales | Australia |
| Clinical Site | Brisbane | Queensland | Australia |
| Clinical Site | Adelaide | South Australia | Australia |
| Clinical Site | Hobart | Tasmania | Australia |
| Clinical Site | Essendon | Victoria | Australia |
| Clinical Site | Glen Waverley | Victoria | Australia |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 26, 2026 | Jun 22, 2026 | 8 | ||
| Jun 22, 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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