Trials / Not Yet Recruiting
Not Yet RecruitingNCT05251636
Adjunct Episcleral Brachytherapy for PCV
A Double-Masked, Multi-center, Active Controlled Safety and Efficacy Study of Adjunct Episcleral Brachytherapy for Polypoid Choroidal Vasculopathy
- Status
- Not Yet Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 159 (estimated)
- Sponsor
- Salutaris Medical Devices, Inc. · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
Summary
This study is investigating the use of episcleral brachytherapy (ESB) adjunct to aflibercept compared to aflibercept monotherapy for the treatment of polyploid choroidal vasculopathy (PCV) in patients experiencing an inadequate response to anti-VEGF monotherapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | Episcleral Brachytherapy | Minimally invasive, single fraction brachytherapy |
| DRUG | Aflibercept Injection | Standard of Care intravitreal aflibercept injection |
Timeline
- Start date
- 2025-03-01
- Primary completion
- 2026-09-01
- Completion
- 2028-09-01
- First posted
- 2022-02-23
- Last updated
- 2023-08-30
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05251636. Inclusion in this directory is not an endorsement.