Trials / Completed
CompletedNCT06708624
Ocular Safety and Usability Study for FYB201 PFS
An Open-Label, Multi-Center, Single-Arm Study to Evaluate the Ocular Safety and Usability of FYB201 Pre-filled Syringe (PFS)
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- Formycon AG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of the study is to assess the ocular safety of the FYB201 pre-filled syringe in terms of preparation and administration by Retina Specialists in the clinical setting.
Conditions
- Age-Related Macular Degeneration
- Branch Retinal Vein Occlusion with Macular Edema
- Central Retinal Vein Occlusion with Macular Edema
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FYB201 0.5 mg (0.05 mL of 10 mg/mL) | IVT administration of FYB201 in a PFS |
Timeline
- Start date
- 2024-06-11
- Primary completion
- 2024-08-08
- Completion
- 2024-08-08
- First posted
- 2024-11-27
- Last updated
- 2024-11-27
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06708624. Inclusion in this directory is not an endorsement.