Study of the Beacon Aqueous Microshunt in Patients With Refractory Glaucoma

NCT04072016 | Terminated DMC FDA Device

• 1 other identifier: 4046
• Study Type: interventional
• Target: 10
• Locations: 2 countries
• Sites: 4

Brief 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.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (2)

• Effectiveness via Intraocular Pressure Reduction

  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

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

  12 Months

Secondary Outcomes (7)

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

  12 Months

• Mean Change from baseline in IOP

  12 Months

• Schirmer tear test - Mean change from baseline

  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

  12 Months

• Number of topical IOP-lowering medications - Mean change from baseline

  12 Months

Study Arms (1)

Beacon Aqueous Microshunt

EXPERIMENTAL

Device: Beacon Aqueous Microshunt

Interventions

Beacon Aqueous Microshunt DEVICE

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.

Beacon Aqueous Microshunt

Eligibility Criteria

• Age: 22 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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".
• \. 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.
• \. Adequate space in the anterior chamber by Spaeth Grade C, D or E for iris insertion (with indentation).
• \. Participant has the understanding, ability, and willingness to fully comply with study procedures and postoperative care instructions.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• MicroOptx: lead

Study Sites (4)

Icon Eye Care

Grand Junction, Colorado, 81501, United States

Location

Minnesota Eye Consultants

Bloomington, Minnesota, 55431, United States

Location

iWorks Laser and Vision Center

Dayton, Ohio, 45405, United States

Location

Institut de l'oeil des Laurentides

Boisbriand, Qubec, J7H 0E8, Canada

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2019
• First Posted: August 28, 2019
• Study Start: April 29, 2020
• Primary Completion: May 16, 2022
• Study Completion: November 30, 2022
• Last Updated: January 10, 2023

Record last verified: 2023-01

Locations

CA (1); US (3)