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NCT05251636Not yet recruitingPhase 3

Adjunct Episcleral Brachytherapy for PCV

A Double-Masked, Multi-center, Active Controlled Safety and Efficacy Study of Adjunct Episcleral Brachytherapy for Polypoid Choroidal Vasculopathy

Source: ClinicalTrials.gov · Last updated 30 Aug 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
159 (estimated)
First submitted
11 Feb 2022
Start date
Mar 2025
Primary completion date
Sept 2026
Lead sponsor
Salutaris Medical Devices, Inc.
NCT number
NCT05251636

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 159
  • From Mar 2025 to the primary completion date, Sept 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous therapeutic radiation to the head or neck that may have resulted in radiation dose to the retina
  • Receiving anti-VEGF therapy for any reason other than AMD

Other illness

  • Type I or Type II diabetes mellitus
  • Fellow eye with worse BCVA than the study eye or other vision-threatening disease not eligible for treatment

Other

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

Who the study is looking for

  • 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

Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.