Trials / Suspended
SuspendedNCT05414747
Clinical Investigation of the Safety and Effectiveness of the ABV-1701 Ocular Endotamponade (OE)
A Prospective Multi-Site Open Label Randomized Controlled Clinical Investigation of the Safety and Effectiveness of the ABV-1701 Ocular Endotamponade (OE)
- Status
- Suspended
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- BioFirst Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A Prospective Multi-Site Open Label Randomized Controlled Clinical Investigation of the Safety and Effectiveness of the ABV-1701 Ocular Endotamponade (OE)
Detailed description
A Prospective Multi-Site Open Label Randomized Controlled Clinical Investigation of the Safety and Effectiveness of the ABV-1701 Ocular Endotamponade (OE) The objective of the investigation is to document the safety and effectiveness of the ABV-1701 OE when compared to the SF6 Gas OE.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ABV-1701 | ABV-1701 is an injectable, in-situ-forming hydrogel, composed of oxidized hyaluronic acid (oxi-HA) and adipic acid dihydrazide (ADH) |
| DEVICE | SF6 Gas | SF6 is a commercial gas tamponade as a vitreous substitute in pars-plana vitrectomy surgery (PPV) |
Timeline
- Start date
- 2023-04-15
- Primary completion
- 2024-12-15
- Completion
- 2025-12-15
- First posted
- 2022-06-10
- Last updated
- 2023-11-18
Locations
4 sites across 2 countries: Australia, Thailand
Source: ClinicalTrials.gov record NCT05414747. Inclusion in this directory is not an endorsement.