Early Evaluation of the Beacon Aqueous Microshunt in Patients Refractory to Drug Therapy in the European Union

NCT03634319 | Terminated FDA Device

• 1 other identifier: 4004-22
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

This is prospective, non-randomized, single-arm study to assess the safety and effectiveness of lowering intraocular pressure with the Beacon Aqueous Microshunt. A total of 65 subjects will be enrolled at five centers. The primary endpoint will be assessed at 12 month follow-up.

Conditions

Glaucoma, Open-Angle

Outcome Measures

Primary Outcomes (2)

• Reduction in IOP

  Overall responder rate, with responder defined as a subject with a diurnal intra-ocular pressure equal to or lower than the individually pre-determined target IOP.

  12 Months

• Adverse Event Rate

  Rate of all AEs

  12 Months

Secondary Outcomes (3)

• Mean Change from Baseline in IOP

  12 Months

• Responder Rate for 20% reduction

  12 Months

• Reduction in IOP lowering medication

  12 Months

Interventions

Beacon Aqueous Microshunt DEVICE

The Beacon Aqueous Microshunt is an implantable device designed to lower intraocular pressure (IOP) in glaucoma patients by shunting aqueous humor from the anterior chamber of the eye to the surface of the eye. Because there are no physiologic sources of outflow resistance, the device can be engineered to target an IOP that is low enough to halt the progression to blindness in a patient suffering from glaucoma.

Eligibility Criteria

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

You may qualify if:

• Age 22 years and older.
• Diagnosed with mild, moderate or severe open-angle glaucoma (OAG).
• Best corrected vision acuity 20/25 or worse in the study eye.
• Inadequate medical control of IOP, or target IOP not reached with intraocular pressure in the study eye greater than or equal to 20 mmHg.
• At least two contiguous clock hours of intact conjunctiva near the limbus between clock hours of 09:00 and 03:00 in the study eye.
• Adequate space in the anterior chamber of the study eye sufficient to support implant with the BAM, defined as two contiguous clock hours of scleral spur visualization via gonioscopy, without compression, in the superior 180 degrees of the anterior angle.
• Any IOP-lowering medications should be stabilized at least 30 days prior to baseline measurements.
• Able and willing to comply with protocol requirements.
• Able to understand and sign the Informed Consent form.

You may not qualify if:

• Active Neovascular Glaucoma in the study eye.
• Pigmentary Glaucoma in the study eye.
• Pseudoexfoliative Glaucoma in the study eye.
• Any eye disease associated with the formation of free-floating material or tissue in the anterior chamber of the eye.
• Corneal conditions in the study eye that may inhibit normal incisional healing (e.g. Fuch's dystrophy) or impair visualization of the implant inside the anterior chamber.
• Anticipated need for ocular surgery within one year in the study eye.
• Contact lens use in the study eye.
• 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.
• Other clinical conditions:
• Poorly controlled diabetes (Type I or Type II) as determined by HbA1c \>8.
• 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 trial during participation in this trial.
• Life expectancy \<1 year.
• Clinically significant macular degeneration in the study eye.

Sponsors & Collaborators

• MicroOptx: lead

Study Sites (2)

University Eye Hospital

Bochum, Germany

Location

Universitatsklinikum Schleswig-Holstein

Lübeck, 23538, Germany

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Study Design

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

Model Details: The Beacon Aqueous Microshunt is an implantable device designed to lower intraocular pressure (IOP) in glaucoma patients by shunting aqueous humor from the anterior chamber of the eye to the surface of the eye. Because there are no physiologic sources of outflow resistance, the device can be engineered to target an IOP that is low enough to halt the progression to blindness in a patient suffering from glaucoma.

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: August 16, 2018
• Study Start: June 1, 2018
• Primary Completion: November 11, 2021
• Study Completion: January 8, 2023
• Last Updated: January 10, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)