Age-Related Macular Degeneration, Polypoid Choroidal Vasculopathy
Conditions
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 experiencing an inadequate response to anti-VEGF monotherapy.
Interventions
RADIATIONEpiscleral Brachytherapy
Minimally invasive, single fraction brachytherapy
Standard of Care intravitreal aflibercept injection
Sponsors
Salutaris Medical Devices, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best Corrected Visual Acuity (BCVA) | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Best Corrected Visual Acuity (BCVA) | 24 months |
| Central Retinal Thickness | 12 and 24 months |
| Lesion size | 12 and 24 months |
Contacts
Primary ContactMary Drew
Outcome results
None listed