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NCT Number: NCT05251636

Adjunct Episcleral Brachytherapy for PCV

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.

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Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Macular Degeneration Polypoid Choroidal Vasculopathy Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Episcleral Brachytherapy

Radiation

Minimally invasive, single fraction brachytherapy

Aflibercept Injection

Drug

Standard of Care intravitreal aflibercept injection

Primary outcomes

  1. Best Corrected Visual Acuity (BCVA)

    Time frame: 12 months

Secondary outcomes

  1. Best Corrected Visual Acuity (BCVA)

    Time frame: 24 months

  2. Central Retinal Thickness

    Time frame: 12 and 24 months

  3. Lesion size

    Time frame: 12 and 24 months

Study contacts

Contact information is provided by the study sponsor or research team.

Mary Drew

CONTACT

[email protected]

5206387518

Sponsors and collaborators

Lead sponsor

Salutaris Medical Devices, Inc.

Industry

Registry information

Official study title

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

Acronym: KILAUEA

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Feb 23, 2022
Registry last updated
Aug 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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