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

Sponsor
MicroOptx (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03634319
Collaborator
(none)
65
Enrollment
2
Locations
50
Anticipated Duration (Months)
32.5
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Beacon Aqueous Microshunt
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
65 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention 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.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)
Primary Purpose:
Treatment
Official Title:
Early Evaluation of the Brown Glaucoma Implant in Patients Refractory to Drug Therapy in the European Union
Actual Study Start Date :
Jun 1, 2018
Anticipated Primary Completion Date :
Jul 31, 2022
Anticipated Study Completion Date :
Jul 31, 2022

Outcome Measures

Primary Outcome Measures

  1. Reduction in IOP [12 Months]

    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.

  2. Adverse Event Rate [12 Months]

    Rate of all AEs

Secondary Outcome Measures

  1. Mean Change from Baseline in IOP [12 Months]

    Change in IOP at follow-up compared to baseline

  2. Responder Rate for 20% reduction [12 Months]

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

  3. Reduction in IOP lowering medication [12 Months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:

  10. Poorly controlled diabetes (Type I or Type II) as determined by HbA1c >8.

  11. Cancer requiring treatment during the duration of the study.

  12. Any drugs (e.g.: immunosuppressive drugs) or co- morbidity that might inhibit wound healing.

  13. Participation in any other clinical trial during participation in this trial.

  14. Life expectancy <1 year.

  15. Clinically significant macular degeneration in the study eye.

  16. Patients who have undergone surgery in the trial eye within the last 6 months.

  17. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Eye Hospital Bochum Germany
2 Universitatsklinikum Schleswig-Holstein Lübeck Germany 23538

Sponsors and Collaborators

  • MicroOptx

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
MicroOptx
ClinicalTrials.gov Identifier:
NCT03634319
Other Study ID Numbers:
  • 4004-22
First Posted:
Aug 16, 2018
Last Update Posted:
Feb 2, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle

Study Results

No Results Posted as of Feb 2, 2022