search
Back to results

Adjunct Episcleral Brachytherapy for PCV (KILAUEA)

Primary Purpose

Age-Related Macular Degeneration, Polypoid Choroidal Vasculopathy

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Episcleral Brachytherapy
Aflibercept Injection
Sponsored by
Salutaris Medical Devices, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-Related Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    ESB adjunct to IAI

    IAI monotherapy

    Arm Description

    Single ESB treatment adjunct to intravitreal aflibercept injections (IAI)

    Intravitreal aflibercept injections (IAI)

    Outcomes

    Primary Outcome Measures

    Best Corrected Visual Acuity (BCVA)

    Secondary Outcome Measures

    Best Corrected Visual Acuity (BCVA)
    Central Retinal Thickness
    Lesion size

    Full Information

    First Posted
    February 11, 2022
    Last Updated
    August 28, 2023
    Sponsor
    Salutaris Medical Devices, Inc.
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05251636
    Brief Title
    Adjunct Episcleral Brachytherapy for PCV
    Acronym
    KILAUEA
    Official Title
    A Double-Masked, Multi-center, Active Controlled Safety and Efficacy Study of Adjunct Episcleral Brachytherapy for Polypoid Choroidal Vasculopathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 2025 (Anticipated)
    Primary Completion Date
    September 2026 (Anticipated)
    Study Completion Date
    September 2028 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Salutaris Medical Devices, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    Yes
    Device Product Not Approved or Cleared by U.S. FDA
    Yes

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Age-Related Macular Degeneration, Polypoid Choroidal Vasculopathy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    159 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    ESB adjunct to IAI
    Arm Type
    Experimental
    Arm Description
    Single ESB treatment adjunct to intravitreal aflibercept injections (IAI)
    Arm Title
    IAI monotherapy
    Arm Type
    Active Comparator
    Arm Description
    Intravitreal aflibercept injections (IAI)
    Intervention Type
    Radiation
    Intervention Name(s)
    Episcleral Brachytherapy
    Intervention Description
    Minimally invasive, single fraction brachytherapy
    Intervention Type
    Drug
    Intervention Name(s)
    Aflibercept Injection
    Intervention Description
    Standard of Care intravitreal aflibercept injection
    Primary Outcome Measure Information:
    Title
    Best Corrected Visual Acuity (BCVA)
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Best Corrected Visual Acuity (BCVA)
    Time Frame
    24 months
    Title
    Central Retinal Thickness
    Time Frame
    12 and 24 months
    Title
    Lesion size
    Time Frame
    12 and 24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mary Drew
    Phone
    5206387518
    Email
    mdrew@salutarismd.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Adjunct Episcleral Brachytherapy for PCV

    We'll reach out to this number within 24 hrs