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GlaucomaBeaconNCT04072016

Study of the Beacon Aqueous Microshunt in Patients With Refractory Glaucoma

A study testing Beacon Aqueous Microshunt in people with Glaucoma, run by MicroOptx at 4 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a prospective, multicenter, single-arm clinical study to evaluate the safety and effectiveness of Beacon Aqueous Microshunt in patients with refractory glaucoma. Read more about this study

Who is it for?
Ages 22 to 85 years
Conditions the study is for
Glaucoma
What is being tested?
Beacon Aqueous Microshunt
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
4 sitesin 2 countries
Study dates
29 Apr 2020to 30 Nov 2022
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 22 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 22-85 years.
  • Refractory glaucoma: Prior failure of filtering/cilioablative procedure and/or uncontrolled IOP on maximum-tolerated medication (i.e. >=4 classes of topical lowering medications, or fewer in the case of tolerability or efficacy issues).
  • Primary open-angle, traumatic or neovascular glaucoma.
  • Medicated DIOP ≥20 mmHg and ≤45 mmHg on maximum-tolerated medical therapy. Note: No washout; medications stabilized 30 days prior to assessment.
  • Baseline BCVA of light perception or better in study eye.
  • Visual field defects consistent with glaucomatous optic nerve damage.
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  • Glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities:
  • Diffuse thinning, focal narrowing, or notching of the optic disc rim, especially at the inferior or superior poles with or without disc hemorrhage;
  • Localized abnormalities of the peripapillary retinal nerve fiber layer, especially at the inferior or superior poles; or
  • Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue 8. Visual field mean deviation (MD) by Humphrey Visual Field: Visual field defects consistent with glaucomatous optic nerve damage and mean deviation worse than -3 dB in the study eye; and at least one of the following two findings:
  • A cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level on the pattern deviation (PD) plot; and/or
  • Glaucoma hemi-field test "outside normal limits".
  • 9. At least two contiguous clock hours of intact conjunctiva near the limbus between clock hours of 9:00 and 03:00 in the study eye.
  • 10. Adequate space in the anterior chamber by Spaeth Grade C, D or E for iris insertion (with indentation).
  • 11. Participant has the understanding, ability, and willingness to fully comply with study procedures and postoperative care instructions.
  • 12. Participant understands and signs the informed consent.

Who cannot join

  • No light perception vision.
  • Conditions of active neovascular conditions, such as active iris or corneal neovascularization, or active proliferative retinopathy in study eye.
  • Pigmentary glaucoma in study eye.
  • Pseudoexfoliation syndrome in study eye.
  • Angle-closure glaucoma in study eye.
  • Iridocorneal endothelial syndrome in study eye.
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  • Uveitic glaucoma in the study eye.
  • Epithelial or fibrous downgrowth in the study eye.
  • Best corrected visual acuity (BCVA) worse than 20/200 in the non-study eye.
  • Corneal conditions in study eye inhibiting normal incisional healing (e.g. Fuch's dystrophy) or impair visualization of implant inside the anterior chamber.
  • Prior intraocular surgery in study eye within ≤6 months before the preoperative visit (including phacoemulsification).
  • Central corneal endothelial cell count of less than 1600 cells/mm2 in the study eye.
  • Anticipated need for ocular surgery or retinal laser procedure in the study eye within the 12-month follow-up period.
  • Need for glaucoma surgery combined with other ocular procedures in the study eye at time of implant (e.g. cataract surgery, penetrating keratoplasty, or retinal surgery).
  • Unwilling to discontinue contact lens use in the study eye after surgery.
  • Central corneal thickness ≤490μm or ≥620μm.
  • Clinically significant inflammation or infection in the study eye within 60 days prior to the preoperative visit (e.g., blepharitis, conjunctivitis, keratitis, uveitis, herpes simplex infection) or any systemic infection. For purposes of this study, clinically significant is considered any such condition requiring prescription therapy.
  • Any condition that prevents the device implantation in the superior region of the study eye.
  • Vitreous in the anterior chamber for which a vitrectomy is anticipated.
  • Functionally significant cataract in the study eye.
  • Other clinical conditions:
  • Poorly controlled diabetes (Type I or Type II) as determined by HbA1c >8 within 3 months of implant.
  • Cancer requiring treatment during the duration of the study.
  • Any drugs (e.g.: immunosuppressive drugs) or co-morbidity that might inhibit wound healing.
  • Participation in any other clinical study during participation in this study.
  • Engage in activities that involve submerging their head under water, such as diving or swimming.
  • Women who are (i) pregnant, (ii) nursing, (iii) planning a pregnancy and (iv) of childbearing potential not using a reliable method of contraception.
  • Life expectancy <1 year.
  • If both eyes are eligible, the eye with the worse BCVA will be selected.

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

United States3 sites

  • Minnesota Eye Consultants

    Bloomington, Minnesota, 55431

  • iWorks Laser and Vision Center

    Dayton, Ohio, 45405

  • Icon Eye Care

    Grand Junction, Colorado, 81501

Other trials in United States

Canada1 site

  • Institut de l'oeil des Laurentides

    Boisbriand, Qubec, J7H 0E8

Other trials in Canada

About this study

Official title: The Beacon Study: A Prospective, Multicenter Study to Evaluate the Safety and Effectiveness of Beacon Aqueous Microshunt for Refractory Glaucoma

This is a prospective, multicenter, single-arm clinical study to evaluate the safety and effectiveness of Beacon Aqueous Microshunt in patients with refractory glaucoma.

Conditions
Glaucoma
Being tested
Beacon Aqueous Microshunt
Medical subject headings
Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Beacon Aqueous MicroshuntDevice

    The Beacon Aqueous Microshunt (BAM) is an implantable device intended to reduce intraocular pressure (IOP) in patients with refractory glaucoma by shunting aqueous humor from the anterior chamber to the surface of the eye.

Study groups in NCT04072016
Study groupRoleWhat they receive
Beacon Aqueous MicroshuntExperimentalNot described
Receives: Device: Beacon Aqueous Microshunt

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effectiveness via Intraocular Pressure Reduction

    20% mean diurnal IOP reduction from baseline, on the same number or fewer topical IOP-lowering medications

    Measured: 12 Months

  2. Safety via Serious and Adverse Event Reporting

    Rate of occurrence of serious procedure-related and/or device-related adverse events.

    Measured: 12 Months

Secondary outcomes (7)

  1. Responder rate defined as achieving at least 20% mean diurnal IOP reduction from baseline

    Measured: 12 Months

  2. Mean Change from baseline in IOP

    Measured: 12 Months

  3. Schirmer tear test - Mean change from baseline

    Measured: 12 Months

  4. Proportion of Eyes Achieving Specific IOP Targets (≤18 mmHg, ≤17 mmHg, ≤16 mmHg, ≤15 mmHg, ≤14 mmHg, ≤13 mmHg, and ≤12 mmHg) compared to baseline

    Measured: 12 Months

  5. Number of topical IOP-lowering medications - Mean change from baseline

    Measured: 12 Months

  6. Kaplan-Meier Analysis of Failure

    Glaucoma-related secondary surgical intervention with or without device explant, device explant alone, or not achieving >20% IOP reduction on the same number of medications or fewer

    Measured: 12 Months

  7. Rate of ocular and non-ocular adverse events

    Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2019
  2. Study start29 Apr 2020
  3. Primary completion16 May 2022
  4. Study completion30 Nov 2022

Why it stopped: Significant risks (e.g., infection, endothelial cell loss) and high rate of channel plugging associated with product use.

Resources

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
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04072016
Sponsor's protocol ID
4046
Acronym
Beacon
Status last verified
Jan 2023
First submitted
26 Aug 2019
Last updated
10 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Beacon Aqueous Microshunt in people with Glaucoma, run by MicroOptx at 4 sites in 2 countries.

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 16 inclusion and 29 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: stopped early, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, Canada. 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?

The study was stopped early (reason given: Significant risks (e.g., infection, endothelial cell loss) and high rate of channel plugging associated with product use.). 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?

Effectiveness via Intraocular Pressure Reduction (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04072016.

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 10 Jan 2023; AzTrials last refreshed its copy on 6 Nov 2026.

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