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Multicenter, randomized, masked, controlled study of the safety and effectiveness of intravitreally administered ONS-5010.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ONS-5010 bevacizumab | Experimental |
| |
| ranibizumab | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab | Biological | 1.25 mg, intravitreal injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the Effectiveness of Intravitreal Injections of ONS-5010 Compared to Ranibizumab in Preventing Vision Loss, as Measured by the Mean Change in Baseline Best Correct Visual Acuity (BCVA) at Week 8 | 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, 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Site | Arcadia | California | 91006 | United States | ||
| Clinical Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | ONS-5010 Bevacizumab | ONS-5010 |
| FG001 | Ranibizumab | ranibizumab |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 17, 2024 |
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| ranibizumab | Biological | 0.5mg, intravitreal injection |
|
| Bakersfield |
| California |
| 93309 |
| United States |
| Clinical Site | Beverly Hills | California | 90210 | United States |
| Clinical Site | Huntington Beach | California | 92647 | United States |
| Clinical Site | Laguna Hills | California | 92653 | United States |
| Clinical Site | Long Beach | California | 90807 | United States |
| Clinical Site | Modesto | California | 95356 | United States |
| Clinical Site | Oakland | California | 94611 | United States |
| Clinical Site | Pasadena | California | 91107 | United States |
| Clinical Site | Poway | California | 92064 | United States |
| Clinical Site | Sacramento | California | 95841 | United States |
| Clinical Site | Colorado Springs | Colorado | 80909 | United States |
| Clinical Site | Lakewood | Colorado | 80228 | United States |
| Clinical Site | Waterford | Connecticut | 06385 | United States |
| Clinical Site | Coral Springs | Florida | 33067 | United States |
| Clinical Site | Fort Lauderdale | Florida | 33308 | United States |
| Clinical Site | Jacksonville | Florida | 32216 | United States |
| Clinical Site | Orlando | Florida | 32806 | United States |
| Clinical Site | Stuart | Florida | 34994 | United States |
| Clinical Site | Oak Forest | Illinois | 60452 | United States |
| Clinical Site | Oak Park | Illinois | 03440 | United States |
| Clinical Site | Carmel | Indiana | 46290 | United States |
| Clinical Site | Lenexa | Kansas | 66215 | United States |
| Clinical Site | Lexington | Kentucky | 40509 | United States |
| Clinical Site | Hagerstown | Maryland | 21740 | United States |
| Clinical Site | Edina | Minnesota | 55435 | United States |
| Clinical Site | Saint Louis Park | Minnesota | 55416 | United States |
| Clinical Site | Jackson | Mississippi | 39202 | United States |
| Clinical Site | Teaneck | New Jersey | 07666 | United States |
| Clinical Site | Albuquerque | New Mexico | 87109 | United States |
| Clinical Site | Liverpool | New York | 13088 | United States |
| Clinical Site | Oceanside | New York | 11572 | United States |
| Clinical Site | Rochester | New York | 14620 | United States |
| Clinical Site | Westbury | New York | 11590 | United States |
| Clinical Site | Asheville | North Carolina | 28803 | United States |
| Clinical Site | Hickory | North Carolina | 28602 | United States |
| Clinical Site | Wake Forest | North Carolina | 27587 | United States |
| Clinical Site | Winston-Salem | North Carolina | 27103 | United States |
| Clinical Site | Edmond | Oklahoma | 73013 | United States |
| Clinical Site | Charleston | South Carolina | 29414 | United States |
| Clinical Site | Florence | South Carolina | 29501 | United States |
| Clinical Site | Ladson | South Carolina | 29456 | United States |
| Clinical Site | West Columbia | South Carolina | 29169 | 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 | Arlington | Texas | 76012 | United States |
| Clinical Site | Austin | Texas | 78705 | United States |
| Clinical Site | Beaumont | Texas | 77707 | United States |
| Clinical Site | Bellaire | Texas | 77401 | United States |
| Clinical Site | Dallas | Texas | 75231 | United States |
| Clinical Site | Round Rock | Texas | 78681 | 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 | 79606 | United States |
| Clinical Site | Salt Lake City | Utah | 84107 | United States |
| Clinical Site | Fairfax | Virginia | 22031 | United States |
| Clinical Site | Lynchburg | Virginia | 24502 | United States |
| Clinical Site | Bellevue | Washington | 98004 | United States |
| Clinical Site | Silverdale | Washington | 98383 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ONS-5010 Bevacizumab | ONS-5010 |
| BG001 | Ranibizumab | ranibizumab |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Evaluate the Effectiveness of Intravitreal Injections of ONS-5010 Compared to Ranibizumab in Preventing Vision Loss, as Measured by the Mean Change in Baseline Best Correct Visual Acuity (BCVA) at Week 8 | 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. | Posted | Mean | Standard Deviation | letters | Baseline, 8 weeks |
|
|
|
from enrollment until end of follow-up, up to 12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ONS-5010 Bevacizumab | ONS-5010 | 0 | 200 | 9 | 200 | 24 | 200 |
| EG001 | Ranibizumab | ranibizumab | 0 | 200 | 5 | 200 | 5 | 200 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | Non-systematic Assessment |
| ||
| Coronary artery disease | Cardiac disorders | Non-systematic Assessment |
| ||
| Myocardial infarction | Cardiac disorders | Non-systematic Assessment |
| ||
| Iridocyclitis | Eye disorders | Non-systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Intestinal obstruction | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Bile duct stone | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Cholecystitis acute | Hepatobiliary disorders | Non-systematic Assessment |
| ||
| Appendicitis | Infections and infestations | Non-systematic Assessment |
| ||
| COVID-19 pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Gastroenteritis | Infections and infestations | Non-systematic Assessment |
| ||
| Ankle fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Hip fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Humerus fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Rib fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Muscle spasms | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Basal ganglia stroke | Nervous system disorders | Non-systematic Assessment |
| ||
| Transient ischaemic attack | Nervous system disorders | Non-systematic Assessment |
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| Hydronephrosis | Renal and urinary disorders | Non-systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
| ||
| Hypertension | Vascular disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Kissner, PhD | Outlook Therapeutics, Inc | 609.619.3990 | jenniferkissner@outlooktherapeutics.com |
| May 26, 2026 |
| Prot_SAP_000.pdf |
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| 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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| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|