Early Evaluation of the Beacon Aqueous Microshunt in Patients Refractory to Drug Therapy in the European Union (EARLY BIRD EU)

Early Evaluation of the Brown Glaucoma Implant in Patients Refractory to Drug Therapy in the European Union

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.

Study Overview

• Status: Terminated
• Conditions: Glaucoma, Open-Angle
• Intervention / Treatment: Device: Beacon Aqueous Microshunt

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Bochum, Germany
    • University Eye Hospital
  • Lübeck, Germany, 23538
    • Universitätsklinikum Schleswig-Holstein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 22 years and older.
2. Diagnosed with mild, moderate or severe open-angle glaucoma (OAG).
3. Best corrected vision acuity 20/25 or worse in the study eye.
4. Inadequate medical control of IOP, or target IOP not reached with intraocular pressure in the study eye greater than or equal to 20 mmHg.
5. 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.
6. 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.
7. Any IOP-lowering medications should be stabilized at least 30 days prior to baseline measurements.
8. Able and willing to comply with protocol requirements.
9. Able to understand and sign the Informed Consent form.

Exclusion Criteria:

1. Active Neovascular Glaucoma in the study eye.
2. Pigmentary Glaucoma in the study eye.
3. Pseudoexfoliative Glaucoma in the study eye.
4. Any eye disease associated with the formation of free-floating material or tissue in the anterior chamber of the eye.
5. 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.
6. Anticipated need for ocular surgery within one year in the study eye.
7. Contact lens use in the study eye.
8. 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.

9. Other clinical conditions:

   1. Poorly controlled diabetes (Type I or Type II) as determined by HbA1c >8.
   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.
10. Participation in any other clinical trial during participation in this trial.
11. Life expectancy <1 year.
12. Clinically significant macular degeneration in the study eye.
13. Patients who have undergone surgery in the trial eye within the last 6 months.
14. Planned combined cataract surgery.

If both eyes of a prospective trial participant are eligible, the eye with the highest intraocular pressure will be selected for implant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change from Baseline in IOP	Change in IOP at follow-up compared to baseline	12 Months
Responder Rate for 20% reduction	Defined as a subject achieving at least 20% reduction from baseline in IOP	12 Months
Reduction in IOP lowering medication	Change in number of medications at follow-up compared to baseline	12 Months

Collaborators and Investigators

• Sponsor: MicroOptx

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): November 11, 2021
• Study Completion (Actual): January 8, 2023

Study Registration Dates

• First Submitted: June 25, 2018
• First Submitted That Met QC Criteria: August 14, 2018
• First Posted (Actual): August 16, 2018

Study Record Updates

• Last Update Posted (Estimate): January 10, 2023
• Last Update Submitted That Met QC Criteria: January 8, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: 4004-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes