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Trial record 3 of 3 for:    microoptx | glaucoma

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03634319
Recruitment Status : Active, not recruiting
First Posted : August 16, 2018
Last Update Posted : February 2, 2022
Sponsor:
Information provided by (Responsible Party):
MicroOptx

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
Glaucoma, Open-Angle Device: Beacon Aqueous Microshunt Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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.

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 : June 1, 2018
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma


Intervention Details:
  • Device: Beacon Aqueous Microshunt

    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.



Primary Outcome Measures :
  1. Reduction in IOP [ Time Frame: 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 [ Time Frame: 12 Months ]
    Rate of all AEs


Secondary Outcome Measures :
  1. Mean Change from Baseline in IOP [ Time Frame: 12 Months ]
    Change in IOP at follow-up compared to baseline

  2. Responder Rate for 20% reduction [ Time Frame: 12 Months ]
    Defined as a subject achieving at least 20% reduction from baseline in IOP

  3. Reduction in IOP lowering medication [ Time Frame: 12 Months ]
    Change in number of medications at follow-up compared to baseline



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03634319


Locations
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Germany
University Eye Hospital
Bochum, Germany
Universitatsklinikum Schleswig-Holstein
Lübeck, Germany, 23538
Sponsors and Collaborators
MicroOptx
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Responsible Party: MicroOptx
ClinicalTrials.gov Identifier: NCT03634319    
Other Study ID Numbers: 4004-22
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: February 2, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
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
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases