Trials / Active Not Recruiting
Active Not RecruitingNCT05112861
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
A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus PFS in Subjects With Visual Impairment Due to Retinal Disorders, NORSE SEVEN
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Outlook Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | bevacizumab | 1.25 mg, intravitreal injection |
Timeline
- Start date
- 2021-11-15
- Primary completion
- 2025-03-01
- Completion
- 2025-03-01
- First posted
- 2021-11-09
- Last updated
- 2024-04-02
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05112861. Inclusion in this directory is not an endorsement.