Trials / Completed
CompletedNCT04481386
A Phase I Study of Vitargus® in Vitrectomy
A Phase I, Safety and Tolerability Study of Vitargus® in Vitrectomy Surgery
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 11 (actual)
- Sponsor
- BioFirst Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A Phase I, safety and tolerability study of Vitargus® in vitrectomy surgery
Detailed description
Study Objectives: Primary Objective • To evaluate the safety/tolerability of a single intravitreal (IVT) dose of BFC-1401 in participants as a vitreous substitute during vitrectomy surgery. Secondary Objective * To assess retinal attachment and hydrogel degradation at Day 120. * To assess best corrected visual acuity (BCVA) after vitrectomy surgery.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Vitargus, BFC-1401 | A single intravitreal (IVT) dose of BFC-1401 in participants as a vitreous substitute during vitrectomy surgery. |
Timeline
- Start date
- 2017-02-01
- Primary completion
- 2018-07-02
- Completion
- 2018-07-02
- First posted
- 2020-07-22
- Last updated
- 2020-09-09
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT04481386. Inclusion in this directory is not an endorsement.