Adjunct Episcleral Brachytherapy for PCV

Sponsor
Salutaris Medical Devices, Inc.
Study ID
NCT05251636
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Episcleral Brachytherapy — RADIATION
    Minimally invasive, single fraction brachytherapy
  • Aflibercept Injection — DRUG
    Standard of Care intravitreal aflibercept injection

Study Details

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.

Key Dates

Start date
Mar 31, 2025
Status verified
Aug 2023
Primary completion
Sep 30, 2026
Completion
Sep 30, 2028

Study Design

Enrollment
159 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ESB adjunct to IAI
    Single ESB treatment adjunct to intravitreal aflibercept injections (IAI)
  • Active Comparator: IAI monotherapy
    Intravitreal aflibercept injections (IAI)

Primary Outcome Measure

Best Corrected Visual Acuity (BCVA) [ Time Frame: 12 months ]

Central Contacts

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