Study of the Beacon Aqueous Microshunt in Patients With Refractory Glaucoma (Beacon)

January 8, 2023 updated by: MicroOptx

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Qubec
      • Boisbriand, Qubec, Canada, J7H 0E8
        • Institut De L'Oeil Des Laurentides
  • United States
    • Colorado
      • Grand Junction, Colorado, United States, 81501
        • ICON Eye Care
    • Minnesota
      • Bloomington, Minnesota, United States, 55431
        • Minnesota Eye Consultants
    • Ohio
      • Dayton, Ohio, United States, 45405
        • Iworks Laser and Vision Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 22-85 years.
  2. 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).
  3. Primary open-angle, traumatic or neovascular glaucoma.
  4. Medicated DIOP ≥20 mmHg and ≤45 mmHg on maximum-tolerated medical therapy. Note: No washout; medications stabilized 30 days prior to assessment.
  5. Baseline BCVA of light perception or better in study eye.
  6. Visual field defects consistent with glaucomatous optic nerve damage.

  7. 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.

Exclusion Criteria:

  1. No light perception vision.
  2. Conditions of active neovascular conditions, such as active iris or corneal neovascularization, or active proliferative retinopathy in study eye.
  3. Pigmentary glaucoma in study eye.
  4. Pseudoexfoliation syndrome in study eye.
  5. Angle-closure glaucoma in study eye.
  6. Iridocorneal endothelial syndrome in study eye.
  7. Uveitic glaucoma in the study eye.
  8. Epithelial or fibrous downgrowth in the study eye.
  9. Best corrected visual acuity (BCVA) worse than 20/200 in the non-study eye.
  10. Corneal conditions in study eye inhibiting normal incisional healing (e.g. Fuch's dystrophy) or impair visualization of implant inside the anterior chamber.
  11. Prior intraocular surgery in study eye within ≤6 months before the preoperative visit (including phacoemulsification).
  12. Central corneal endothelial cell count of less than 1600 cells/mm2 in the study eye.
  13. Anticipated need for ocular surgery or retinal laser procedure in the study eye within the 12-month follow-up period.
  14. 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).
  15. Unwilling to discontinue contact lens use in the study eye after surgery.
  16. Central corneal thickness ≤490μm or ≥620μm.
  17. 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.
  18. Any condition that prevents the device implantation in the superior region of the study eye.
  19. Vitreous in the anterior chamber for which a vitrectomy is anticipated.
  20. Functionally significant cataract in the study eye.

  21. Other clinical conditions:

    1. Poorly controlled diabetes (Type I or Type II) as determined by HbA1c >8 within 3 months of implant.
    2. Cancer requiring treatment during the duration of the study.
    3. Any drugs (e.g.: immunosuppressive drugs) or co-morbidity that might inhibit wound healing.
  22. Participation in any other clinical study during participation in this study.
  23. Engage in activities that involve submerging their head under water, such as diving or swimming.
  24. Women who are (i) pregnant, (ii) nursing, (iii) planning a pregnancy and (iv) of childbearing potential not using a reliable method of contraception.
  25. Life expectancy <1 year.

If both eyes are eligible, the eye with the worse BCVA will be selected.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Beacon Aqueous Microshunt
Device: Beacon Aqueous Microshunt
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Effectiveness via Intraocular Pressure Reduction
Time Frame: 12 Months
20% mean diurnal IOP reduction from baseline, on the same number or fewer topical IOP-lowering medications
12 Months
Safety via Serious and Adverse Event Reporting
Time Frame: 12 Months
Rate of occurrence of serious procedure-related and/or device-related adverse events.
12 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Responder rate defined as achieving at least 20% mean diurnal IOP reduction from baseline
Time Frame: 12 Months
12 Months
Mean Change from baseline in IOP
Time Frame: 12 Months
12 Months
Schirmer tear test - Mean change from baseline
Time Frame: 12 Months
12 Months
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
Time Frame: 12 Months
12 Months
Number of topical IOP-lowering medications - Mean change from baseline
Time Frame: 12 Months
12 Months
Kaplan-Meier Analysis of Failure
Time Frame: 12 Months
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
12 Months
Rate of ocular and non-ocular adverse events
Time Frame: 12 Months
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MicroOptx

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 29, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 16, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2019

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 4046

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Glaucoma

Clinical Trials on Beacon Aqueous Microshunt

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings