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Adjunct Episcleral Brachytherapy for PCV

NCT05251636 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2023-08-30

No results posted yet for this study

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

  • Age-Related Macular Degeneration
  • Polypoid Choroidal Vasculopathy

Interventions

RADIATION

Episcleral Brachytherapy

Minimally invasive, single fraction brachytherapy

DRUG

Aflibercept Injection

Standard of Care intravitreal aflibercept injection

Sponsors & Collaborators

  • Salutaris Medical Devices, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-31
Primary Completion
2026-09-30
Completion
2028-09-30
FDA Drug
Yes
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05251636 on ClinicalTrials.gov