Adjunct Episcleral Brachytherapy for PCV

Phase 3

Not yet recruiting

• Conditions: Polypoid Choroidal Vasculopathy; Age-Related Macular Degeneration
• Interventions: Drug: Aflibercept Injection; Radiation: Episcleral Brachytherapy

• Registration Number: NCT05251636
• Lead Sponsor: Salutaris Medical Devices, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-11
• Study First Submitted QC: 2022-02-21
• Study First Posted: 2022-02-23
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-30
• Study Start: 2025-03
• Primary Completion: 2026-09
• Study Completion: 2028-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 159

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IAI monotherapy	Aflibercept Injection	Intravitreal aflibercept injections (IAI)
ESB adjunct to IAI	Episcleral Brachytherapy	Single ESB treatment adjunct to intravitreal aflibercept injections (IAI)
ESB adjunct to IAI	Aflibercept Injection	Single ESB treatment adjunct to intravitreal aflibercept injections (IAI)

Primary Outcome Measures

Name	Time	Method
Best Corrected Visual Acuity (BCVA)	12 months

Secondary Outcome Measures

Name	Time	Method
Best Corrected Visual Acuity (BCVA)	24 months
Central Retinal Thickness	12 and 24 months
Lesion size	12 and 24 months