Adjunct Episcleral Brachytherapy for PCV (KILAUEA)

Salutaris Medical Devices

Status and phase: Not yet enrolling; Phase 3

Conditions: Age-Related Macular Degeneration; Polypoid Choroidal Vasculopathy

Treatments: Radiation: Episcleral Brachytherapy; Drug: Aflibercept Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT05251636

SMD-202101

Details and patient eligibility

About

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.

Enrollment: 159 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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159 participants in 2 patient groups

ESB adjunct to IAI

Experimental group

Description:

Single ESB treatment adjunct to intravitreal aflibercept injections (IAI)

Treatment:

Drug: Aflibercept Injection

Radiation: Episcleral Brachytherapy

IAI monotherapy

Active Comparator group

Description:

Intravitreal aflibercept injections (IAI)

Treatment:

Drug: Aflibercept Injection