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

Primary Purpose

Glaucoma, Open-Angle

Status

Terminated

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Beacon Aqueous Microshunt

About this trial

This is an interventional treatment trial for Glaucoma, Open-Angle

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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:
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.
Participation in any other clinical trial during participation in this trial.
Life expectancy <1 year.
Clinically significant macular degeneration in the study eye.
Patients who have undergone surgery in the trial eye within the last 6 months.
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.

Sites / Locations

University Eye Hospital
Universitatsklinikum Schleswig-Holstein

Outcomes

Primary Outcome Measures

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.

Adverse Event Rate

Rate of all AEs

Secondary Outcome Measures

Mean Change from Baseline in IOP

Change in IOP at follow-up compared to baseline

Responder Rate for 20% reduction

Defined as a subject achieving at least 20% reduction from baseline in IOP

Reduction in IOP lowering medication

Change in number of medications at follow-up compared to baseline

Full Information

NCT ID

NCT03634319

First Posted

June 25, 2018

Last Updated

January 8, 2023

Sponsor

MicroOptx

1. Study Identification

Unique Protocol Identification Number

NCT03634319

Brief Title

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

Acronym

EARLY BIRD EU

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Terminated

Why Stopped

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

Study Start Date

June 1, 2018 (Actual)

Primary Completion Date

November 11, 2021 (Actual)

Study Completion Date

January 8, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

MicroOptx

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma, Open-Angle

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

Beacon Aqueous Microshunt

Intervention Description

Primary Outcome Measure Information:

Title

Reduction in IOP

Description

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.

Time Frame

12 Months

Title

Adverse Event Rate

Description

Rate of all AEs

Time Frame

12 Months

Secondary Outcome Measure Information:

Title

Mean Change from Baseline in IOP

Description

Change in IOP at follow-up compared to baseline

Time Frame

12 Months

Title

Responder Rate for 20% reduction

Description

Defined as a subject achieving at least 20% reduction from baseline in IOP

Time Frame

12 Months

Title

Reduction in IOP lowering medication

Description

Change in number of medications at follow-up compared to baseline

Time Frame

12 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. Patients who have undergone surgery in the trial eye within the last 6 months. 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.

Facility Information:

Facility Name

University Eye Hospital

City

Bochum

Country

Germany

Facility Name

Universitatsklinikum Schleswig-Holstein

City

Lübeck

ZIP/Postal Code

23538

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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