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Trial record 39 of 1617 for:    glaucoma

Early Evaluation of the Brown Glaucoma Implant in Patients Refractory to Drug Therapy in the European Union (EARLY BIRD EU)

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ClinicalTrials.gov Identifier: NCT03634319
Recruitment Status : Recruiting
First Posted : August 16, 2018
Last Update Posted : August 16, 2018
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 Brown Glaucoma Implant. A total of 50 subjects will be enrolled at three centers. Subjects will be followed for 12 months, with the primary assessments completed 6 months after implant.

Condition or disease Intervention/treatment Phase
Glaucoma, Open-Angle Device: Brown Glaucoma Implant Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:

The Brown Glaucoma Implant (BGI) 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 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma


Intervention Details:
  • Device: Brown Glaucoma Implant

    The Brown Glaucoma Implant (BGI) 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: 6 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: 6 Months ]
    Rate of all AEs


Secondary Outcome Measures :
  1. Mean Change from Baseline in IOP [ Time Frame: 6 Months ]
    Change in IOP at follow-up compared to baseline

  2. Responder Rate for 20% reduction [ Time Frame: 6 Months ]
    Defined as a subject achieving at least 20% reduction from baseline in IOP

  3. Responder Rate for IOP <=14mmHg [ Time Frame: 6 Months ]
    Defined as achieving follow‐up IOP less than or equal to 14 mmHg



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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. 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
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Contact: Roy Martin 763-670-5600 rmartin@microoptx.com
Contact: Amy Derosier 612-638-7804 aderosier@microoptx.com

Locations
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Germany
University Eye Hospital Recruiting
Bochum, Germany
Principal Investigator: Burkhard Dick         
Sub-Investigator: Inga Kersten-Gomez         
Sponsors and Collaborators
MicroOptx

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Responsible Party: MicroOptx
ClinicalTrials.gov Identifier: NCT03634319     History of Changes
Other Study ID Numbers: 4004‐22
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: June 2018
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
Pediatric Postmarket Surveillance of a Device Product: No
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