A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders
NCT05112861 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2026-04-22
Summary
The study will compare the safety of ophthalmic bevacizumab in vials versus pre-filled syringes 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.
Conditions
- Age-Related Macular Degeneration
- Neovascular Age-related Macular Degeneration
- Wet Macular Degeneration
- BRVO - Branch Retinal Vein Occlusion
- Diabetic Macular Edema
Interventions
- BIOLOGICAL
-
1.25 mg, intravitreal injection
Sponsors & Collaborators
-
Outlook Therapeutics, Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-11-15
- Primary Completion
- 2027-12-31
- Completion
- 2027-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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