Macular Degeneration, Choroidal NeovascularizationNEAMESNCT02988895
Episcleral Brachytherapy for the Treatment of Wet AMD
A study testing episcleral brachytherapy in people with Macular Degeneration, Choroidal Neovascularization, run by Salutaris Medical Devices, Inc. at 2 sites in United States.
Trial summary
This is a prospective, multi-site, safety and feasibility study of the SalutarisMD SMD-DA system for retrobulbar minimally invasive episcleral brachytherapy device in patients receiving and not responding to anti-VEGF therapy for nAMD. The trial will be open label and non-randomized. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration, Choroidal Neovascularization
- What is being tested?
- episcleral brachytherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2017to May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Diagnosis of active CNV or PCV due to nAMD
- Poor or non-responsive to FDA approved intravitreal anti-VEGF therapy for nAMD
- BCVA 20/63 or worse Snellen equivalent in the study eye
- Ability to understand nature/purpose of trial and to provide informed consent
- Ability to undergo diagnostic tests and surgical interventions
- Ability to follow instructions and complete the trial including all scheduled visits and follow-up
Who cannot join
- Neovascularization other than due to AMD
- Sub-foveal lesion hemorrhage obscuring >50% of lesion
- Targeted neovascular lesion with greatest linear dimension >3750 microns or <1000 microns as determined by angiography
- Presence of subretinal fibrosis, including disciform scar, or retinal pigment epithelial (RPE) atrophy that is extensive or foveal threatening in the study eye
- An existing retinal pigment epithelial (RPE) tear
- Previous treatment (excluding vitamins) for nAMD in the study eye other than anti-VEGF therapy in the last 6 months
Show all 24Show fewer
- A change in anti-VEGF agent in the previous two administrations
- Anticipate a change to the anti-VEGF agent during the conduct of the study
- Other clinically significant ocular co-morbidity including, but not limited to, glaucoma, optic neuropathy of any cause, maculopathy / retinopathy of any cause other than nAMD, scleritis, enophthalmos, microphthalmia, or other co-morbidities that in the investigator's opinion could require medical or surgical intervention to prevent or treat visual loss or media opacity that might result from that condition (i.e. severe cataracts).
- Previous intraocular surgery in study eye other than for uncomplicated phacoemulsification cataract extraction
- High myopia indicated by a history of refractive error of - 6D or greater (spherical equivalent), demonstrated myopic degeneration, or axial length of >26.5mm.
- Subjects with orbital structural abnormalities, such as small (axial length <21 mm), deep set globes or other globe dystopias that, in the investigator's clinical judgment, would require a change in the angle of insertion or increase the risk of structural damage from retrobulbar anesthesia, sub-Tenon's anesthesia, or retrobulbar device positioning.
- Media opacity sufficient to preclude adequate fundoscopy, OCT, or angiography
- Uncontrolled systemic diseases (e.g. controlled hypertension is acceptable)
- Type I or type II diabetes mellitus
- Any previous therapeutic radiation to the head or neck or other areas that may have resulted in a radiation dose to the retina.
- On anticoagulation or dual anti-platelet therapy with abnormal coagulation panel results.
- Patient unsuitable for IV or local anesthesia
- Any contraindication to anti-VEGF, fluorescein, indocyanine green, topical and local anesthetics, topical antiseptics, or topical antibiotics to be used during the study
- Active ocular or periocular infection or intraocular inflammation
- Fellow eye with a BCVA of 20/63 Snellen Equivalent or worse, with advanced AMD (neovascular or non-exudative AMD with foveal geographic atrophy), or other vision threatening disease that is not eligible for vision restoring treatment (i.e. inoperable cataracts).
- Fellow eye is receiving anti-VEGF therapy
- Have received any investigational treatment for any indication in the previous 30 days
- Any condition which, in the investigators' opinion, would conflict or otherwise prevent the subject from complying with the required procedures, schedule or other study conduct
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Retina Consultants of Hawaii
‘Aiea, Hawaii, 96701
University Retina
Oak Forest, Illinois, 60452
About this study
Official title: A Prospective Study of Episcleral Brachytherapy for the Treatment of Neovascular Age-related Macular Degeneration
This is a prospective, multi-site, safety and feasibility study of the SalutarisMD SMD-DA system for retrobulbar minimally invasive episcleral brachytherapy device in patients receiving and not responding to anti-VEGF therapy for nAMD. The trial will be open label and non-randomized. The study intervention is a one-time intervention and requires no alteration to the standard of care during the follow-up period.
Read the detailed description
Subjects will receive a single brachytherapy treatment and 36 months of follow-up.
- Being tested
- episcleral brachytherapy
- Keywords
- Brachytherapy, Wet AMD
- Medical subject headings
- Choroidal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
episcleral brachytherapyRadiation
Also called Strontium 90
The study intervention is an outpatient, ambulatory procedure performed under local anesthesia with anesthesia assist.
| Study group | Role | What they receive |
|---|---|---|
| episcleral brachytherapy | Experimental | single fraction of 24 Gy Strontium90 episcleral brachytherapy Receives: Radiation: episcleral brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of the study intervention
Adverse event assessment
Measured: 26 weeks
Tolerability of the study intervention
Subject pain score during procedure
Measured: During procedure
Feasibility of the study intervention
Investigator ability to place the device and deliver a therapeutic dose
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study start1 Aug 2017
- Primary completion26 May 2023
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular Degeneration, Choroidal NeovascularizationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
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
- NCT02988895
- Sponsor's protocol ID
- SMD-201601
- Acronym
- NEAMES
- Status last verified
- Aug 2023
- First submitted
- 6 Dec 2016
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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 Prospective Study of Episcleral Brachytherapy for the Treatment of Neovascular Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT02988895
- Acronym / sponsor ID
- NEAMES / SMD-201601
- Keywords
- Brachytherapy, Wet AMD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Salutaris Medical Devices, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 26 May 2023 (actual)
- Study completion
- May 2025 (estimated)
- First posted
- 9 Dec 2016 (estimated)
- 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 is a prospective, multi-site, safety and feasibility study of the SalutarisMD SMD-DA system for retrobulbar minimally invasive episcleral brachytherapy device in patients receiving and not responding to anti-VEGF therapy for nAMD. The trial will be open label and non-randomized. The study intervention is a one-time intervention and requires no alteration to the standard of care during the follow-up period.
Detailed description
Subjects will receive a single brachytherapy treatment and 36 months of follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| episcleral brachytherapy | Experimental | Radiation: episcleral brachytherapysingle fraction of 24 Gy Strontium90 episcleral brachytherapy |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of active CNV or PCV due to nAMD
- Poor or non-responsive to FDA approved intravitreal anti-VEGF therapy for nAMD
- BCVA 20/63 or worse Snellen equivalent in the study eye
- Ability to understand nature/purpose of trial and to provide informed consent
- Ability to undergo diagnostic tests and surgical interventions
Key exclusion criteria (24 listed)
- Neovascularization other than due to AMD
- Sub-foveal lesion hemorrhage obscuring >50% of lesion
- Targeted neovascular lesion with greatest linear dimension >3750 microns or <1000 microns as determined by angiography
- Presence of subretinal fibrosis, including disciform scar, or retinal pigment epithelial (RPE) atrophy that is extensive or foveal threatening in the study eye
- An existing retinal pigment epithelial (RPE) tear
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 brachytherapyAlso: Strontium 90The study intervention is an outpatient, ambulatory procedure performed under local anesthesia with anesthesia assist. | Radiation | episcleral brachytherapy |
Primary outcome
Safety of the study intervention
Time frame: 26 weeks
Adverse event assessment
Tolerability of the study intervention
Time frame: During procedure
Subject pain score during procedure
Feasibility of the study intervention
Time frame: 1 day
Investigator ability to place the device and deliver a therapeutic dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing episcleral brachytherapy in people with Macular Degeneration, Choroidal Neovascularization, run by Salutaris Medical Devices, Inc. at 2 sites in United States.
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 6 inclusion and 24 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: status not confirmed, 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.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of the study intervention (time frame: 26 weeks). The study lists 3 primary outcomes in all. 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.