Adjunct Episcleral Brachytherapy for PCV

Age-Related Macular Degeneration Clinical Trial

— KILAUEA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05251636
• Other study ID #: SMD-202101
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: March 2025
• Est. completion date: September 2028

Study information

• Verified date: August 2023
• Source: Salutaris Medical Devices, Inc.
• Contact: Mary Drew
• Phone: 5206387518
• Email: mdrew[@]salutarismd.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 159
• Est. completion date: September 2028
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration
• Vascular Diseases

Intervention

Radiation:
• Episcleral Brachytherapy
Minimally invasive, single fraction brachytherapy

Drug:
• Aflibercept Injection
Standard of Care intravitreal aflibercept injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Salutaris Medical Devices, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best Corrected Visual Acuity (BCVA)		12 months
Secondary	Best Corrected Visual Acuity (BCVA)		24 months
Secondary	Central Retinal Thickness		12 and 24 months
Secondary	Lesion size		12 and 24 months