Trials / Unknown
UnknownNCT02988895
Episcleral Brachytherapy for the Treatment of Wet AMD
A Prospective Study of Episcleral Brachytherapy for the Treatment of Neovascular Age-related Macular Degeneration
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 11 (actual)
- Sponsor
- Salutaris Medical Devices, Inc. · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, multi-site, safety and feasibility study of the SalutarisMD SMD-DA system for retrobulbar minimally invasive episcleral brachytherapy device in patients receiving and not responding to anti-VEGF therapy for nAMD. The trial will be open label and non-randomized. The study intervention is a one-time intervention and requires no alteration to the standard of care during the follow-up period.
Detailed description
Subjects will receive a single brachytherapy treatment and 36 months of follow-up.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | episcleral brachytherapy | The study intervention is an outpatient, ambulatory procedure performed under local anesthesia with anesthesia assist. |
Timeline
- Start date
- 2017-08-01
- Primary completion
- 2023-05-26
- Completion
- 2025-05-01
- First posted
- 2016-12-09
- Last updated
- 2023-08-30
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02988895. Inclusion in this directory is not an endorsement.