Status:
NOT_YET_RECRUITING
Adjunct Episcleral Brachytherapy for PCV
Lead Sponsor:
Salutaris Medical Devices, Inc.
Conditions:
Age-Related Macular Degeneration
Polypoid Choroidal Vasculopathy
Eligibility:
All Genders
50+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
159 Patients enrolled
Trial Details
Trial ID
NCT05251636
Start Date
March 1 2025
End Date
September 1 2028
Last Update
August 30 2023
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