Adjunct Episcleral Brachytherapy for PCV

• Status: Not yet recruiting
• Trial end date: 2026-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Salutaris Medical Devices, Inc.
• Treatments: Aflibercept

Criteria

Inclusion Criteria:

• Active PCV due to nAMD

• Incomplete response to anti-VEGF

• Received at least 3 consecutive and sequential anti-VEGF injections (no missed treatments)

• Ability to undergo ESB intervention

Exclusion Criteria:

• Sub-retinal fibrosis

• Type I or Type II diabetes mellitus

• Previous therapeutic radiation to the head or neck that may have resulted in radiation dose to the retina

• Study eye with BCVA of worse than 20 ETDRS letters (20/400 Snellen)

• Fellow eye with worse BCVA than the study eye or other vision-threatening disease not eligible for treatment

• Receiving anti-VEGF therapy for any reason other than AMD