Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03634319
Recruitment Status : Recruiting
First Posted : August 16, 2018
Last Update Posted : July 17, 2020
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

Layout table for study information
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 : December 2021
Estimated Study Completion Date : December 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.


Layout table for eligibility information
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. Any IOP‐lowering medications should be stabilized at least 30 days prior to baseline measurements.
  4. Able and willing to comply with protocol requirements.
  5. Able to understand and sign the Informed Consent form.

Exclusion Criteria:

  1. Active Neovascular Glaucoma in the study eye.
  2. 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.
  3. Anticipated need for ocular surgery within one year in the study eye.
  4. Contact lens use in the study eye.
  5. Clinically significant inflammation or infection in the study eye within 60 days prior to the preoperative visit
  6. Patients who have undergone surgery in the trial eye within the last 6 months. Note that planned simultaneous cataract surgery is not an exclusion criterion
  7. Angle closure glaucoma

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


Contacts
Layout table for location contacts
Contact: Roy Martin 763-670-5600 rmartin@microoptx.com
Contact: Amy Derosier 612-638-7804 aderosier@microoptx.com

Locations
Layout table for location information
Austria
Hanusch Krankenhaus - Sterngasse Not yet recruiting
Vienna, Austria, 1010
Principal Investigator: Prof. Oliver Findl, MD         
Germany
University Eye Hospital Recruiting
Bochum, Germany
Principal Investigator: Burkhard Dick         
Sub-Investigator: Inga Kersten-Gomez         
Asklepios Klink Nord Not yet recruiting
Hamburg, Germany, 22417
Principal Investigator: Marc Schargus, MD         
Universitatsklinikum Schleswig-Holstein Not yet recruiting
Lübeck, Germany, 23538
Principal Investigator: Prof. Salvatore Grisanti, MD         
Johannes Gutenberg-University Mainz Langenbeckstr Active, not recruiting
Mainz, Germany, 55131
Sponsors and Collaborators
MicroOptx
Layout table for additonal information
Responsible Party: MicroOptx
ClinicalTrials.gov Identifier: NCT03634319    
Other Study ID Numbers: 4004‐22
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: July 17, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases