Adjunct Episcleral Brachytherapy for PCV (KILAUEA)

August 28, 2023 updated by: Salutaris Medical Devices, Inc.

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

159

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ESB adjunct to IAI
Single ESB treatment adjunct to intravitreal aflibercept injections (IAI)
Radiation: Episcleral Brachytherapy
Minimally invasive, single fraction brachytherapy
Drug: Aflibercept Injection
Standard of Care intravitreal aflibercept injection
Active Comparator: IAI monotherapy
Intravitreal aflibercept injections (IAI)
Drug: Aflibercept Injection
Standard of Care intravitreal aflibercept injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Best Corrected Visual Acuity (BCVA)
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Best Corrected Visual Acuity (BCVA)
Time Frame: 24 months
24 months
Central Retinal Thickness
Time Frame: 12 and 24 months
12 and 24 months
Lesion size
Time Frame: 12 and 24 months
12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Salutaris Medical Devices, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

February 11, 2022

First Submitted That Met QC Criteria

February 21, 2022

First Posted (Actual)

February 23, 2022

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 28, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMD-202101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Age-Related Macular Degeneration

Clinical Trials on Episcleral Brachytherapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe