Adjunct Episcleral Brachytherapy for PCV
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Episcleral Brachytherapy, Aflibercept Injection.
- Who it may be relevant to
- Registry conditions: Age-Related Macular Degeneration, Polypoid Choroidal Vasculopathy. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Double-Masked, Multi-center, Active Controlled Safety and Efficacy Study of Adjunct Episcleral Brachytherapy for Polypoid Choroidal Vasculopathy
Overview
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.
Interventions
- Radiation Episcleral Brachytherapy
Minimally invasive, single fraction brachytherapy - Drug Aflibercept Injection
Standard of Care intravitreal aflibercept injection
Primary outcome measures
- Best Corrected Visual Acuity (BCVA) [Time frame: 12 months]
Secondary outcome measures (3)
- Best Corrected Visual Acuity (BCVA) [Time frame: 24 months]
- Central Retinal Thickness [Time frame: 12 and 24 months]
- Lesion size [Time frame: 12 and 24 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05251636 · SMD-202101