Adjunct Episcleral Brachytherapy for PCV

Phase 3Not Yet RecruitingNCT05251636

Salutaris Medical Devices, Inc.159 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

159

Conditions

Interventions

Episcleral BrachytherapyRADIATION

Minimally invasive, single fraction brachytherapy

Aflibercept InjectionDRUG

Standard of Care intravitreal aflibercept injection

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Best Corrected Visual Acuity (BCVA)

Time frame: 12 months

Secondary Outcomes

Best Corrected Visual Acuity (BCVA)

Time frame: 24 months

Central Retinal Thickness

Time frame: 12 and 24 months

Lesion size

Time frame: 12 and 24 months

Central Contacts

Mary Drew

CONTACT

5206387518 mdrew@salutarismd.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.