A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders
Part of paid clinical trials in Tucson, Arizona.
- Sponsor
- Outlook Therapeutics, Inc.
- Study ID
- NCT04516278
- Phase
- PHASE3
- Status
- Completed
Conditions
- Age-related Macular Degeneration
- BRVO - Branch Retinal Vein Occlusion
- Diabetic Macular Edema
- Neovascular Age-related Macular Degeneration
- Wet Macular Degeneration
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- bevacizumab — BIOLOGICAL1.25 mg, intravitreal injection
Study Details
The study will evaluate the safety of ophthalmic bevacizumab in subjects diagnosed with a retinal condition that would benefit from treatment with intravitreal injection of bevacizumab, including: exudative age-related macular degeneration, diabetic macular edema, or branch retinal vein occlusion.
Key Dates
- First listed
- Aug 18, 2020
- Start date
- Oct 1, 2020
- Status verified
- Mar 2025
- Primary completion
- Feb 10, 2021
- Completion
- Feb 10, 2021
Study Design
- Enrollment
- 195 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Biological: bevacizumabONS-5010
Primary Outcome Measure
Frequency and incidence of treatment-emergent adverse events [ Time Frame: 3 months ]
Locations (20)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Clinical Site | Tucson | Arizona | 85710 | - |
| Clinical Site | Beverly Hills | California | 90211 | - |
| Clinical Site | Glendale | California | 91203 | - |
| Clinical Site | Long Beach | California | 90807 | - |
| Clinical Site | Palm Desert | California | 92260 | - |
| Clinical Site | Poway | California | 92064 | - |
| Clinical Site | Clearwater | Florida | 33761 | - |
| Clinical Site | Winter Haven | Florida | 33880 | - |
| Clinical Site | Oak Forest | Illinois | 60452 | - |
| Clinical Site | Springfield | Illinois | 62704 | - |
| Clinical Site | Hagerstown | Maryland | 21740 | - |
| Clinical Site | Albuquerque | New Mexico | 87109 | - |
| Clinical Site | Chambersburg | Pennsylvania | 17201 | - |
| Clinical Site | Rapid City | South Dakota | 57701 | - |
| Clinical Site | Germantown | Tennessee | 38138 | - |
| Clinical Site | Abilene | Texas | 79606 | - |
| Clinical Site | Arlington | Texas | 76012 | - |
| Clinical Site | McAllen | Texas | 78503 | - |
| Clinical Site | San Antonio | Texas | 78251 | - |
| Clinical Site | Willow Park | Texas | 76087 | - |
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