Age-Related Macular DegenerationPhase 3KILAUEANCT05251636
Adjunct Episcleral Brachytherapy for PCV
A Phase 3 study testing Episcleral Brachytherapy and Aflibercept Injection in people with Age-Related Macular Degeneration and Polypoid Choroidal Vasculopathy, run by Salutaris Medical Devices, Inc..
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-Related Macular Degeneration, Polypoid Choroidal Vasculopathy
- What is being tested?
- Episcleral Brachytherapy and Aflibercept Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Sep 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Double-Masked, Multi-center, Active Controlled Safety and Efficacy Study of Adjunct Episcleral Brachytherapy for Polypoid Choroidal Vasculopathy
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.
- Being tested
- Episcleral Brachytherapy, Aflibercept Injection
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Episcleral BrachytherapyRadiation
Minimally invasive, single fraction brachytherapy
Aflibercept InjectionDrug
Standard of Care intravitreal aflibercept injection
| Study group | Role | What they receive |
|---|---|---|
| ESB adjunct to IAI | Experimental | Single ESB treatment adjunct to intravitreal aflibercept injections (IAI) Receives: Radiation: Episcleral Brachytherapy; Drug: Aflibercept Injection |
| IAI monotherapy | Active comparator | Intravitreal aflibercept injections (IAI) Receives: Drug: Aflibercept Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Visual Acuity (BCVA)
Measured: 12 months
Secondary outcomes (3)
Best Corrected Visual Acuity (BCVA)
Measured: 24 months
Central Retinal Thickness
Measured: 12 and 24 months
Lesion size
Measured: 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study startMar 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Salutaris Medical Devices, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251636
- Sponsor's protocol ID
- SMD-202101
- Acronym
- KILAUEA
- Status last verified
- Aug 2023
- First submitted
- 11 Feb 2022
- Last updated
- 30 Aug 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Masked, Multi-center, Active Controlled Safety and Efficacy Study of Adjunct Episcleral Brachytherapy for Polypoid Choroidal Vasculopathy
- ClinicalTrials.gov ID
- NCT05251636
- Acronym / sponsor ID
- KILAUEA / SMD-202101
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 159 participants (estimated)
- Lead sponsor
- Salutaris Medical Devices, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 23 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESB adjunct to IAI | Experimental | Radiation: Episcleral Brachytherapy, Drug: Aflibercept InjectionSingle ESB treatment adjunct to intravitreal aflibercept injections (IAI) |
| IAI monotherapy | Active comparator | Drug: Aflibercept InjectionIntravitreal aflibercept injections (IAI) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Episcleral BrachytherapyMinimally invasive, single fraction brachytherapy | Radiation | ESB adjunct to IAI |
| Aflibercept InjectionStandard of Care intravitreal aflibercept injection | Drug | ESB adjunct to IAI, IAI monotherapy |
Primary outcome
Best Corrected Visual Acuity (BCVA)
Time frame: 12 months
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Episcleral Brachytherapy and Aflibercept Injection in people with Age-Related Macular Degeneration and Polypoid Choroidal Vasculopathy, run by Salutaris Medical Devices, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary Drew (5206387518, mdrew@salutarismd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Corrected Visual Acuity (BCVA) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.