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Early Feasibility Study of the Brown Glaucoma Implant in Patients With No Light Perceived (Early Bird)

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ClinicalTrials.gov Identifier: NCT03469297
Recruitment Status : Recruiting
First Posted : March 19, 2018
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
MicroOptx

Brief Summary:
This is a prospective, non-randomized, single-arm early feasibility study to assess the safety and feasibility of lowering intraocular pressure with the Brown Glaucoma Implant. A total of 10 subjects will be enrolled at a single center. Subjects will be followed for 24 months, with the primary assessments completed 6 months after implant.

Condition or disease Intervention/treatment Phase
Glaucoma Device: Brown Glaucoma Implant Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Feasibility Study of the Brown Glaucoma Implant in Patients With No Light Perceived
Estimated Study Start Date : March 15, 2018
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Brown Glaucoma Implant 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. Overall Responder Rate [ Time Frame: 6 Months ]
    Responder rate defined as achieving at least 20% reduction from baseline in intra-ocular pressure (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 ]
  2. Alternative Responder Rate [ Time Frame: 6 Months ]
    Responder rate defined as achieving follow-up IOP less than or equal to 14mmHg

  3. Change in IOP-lowering Medications [ Time Frame: 6 Months ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Age 22 years and older
  • No light perception in the study eye.
  • Intraocular pressure in the study eye greater than or equal to 15mmHg and less than or equal to 40mmHg
  • At least two contiguous clock hours of intact conjunctiva near the limbus between clock hours of 9:00 and 3:00 in the study eye
  • Adequate space in the anterior chamber of the study eye sufficient to support implant with the BGI
  • Able and willing to comply with the protocol requirements
  • Able to understand and sign the Informed Consent form

Exclusion Criteria:

  • Active Neovascular Glaucoma in the study 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 or any systemic infection
  • Other clinical conditions including poorly controlled diabetes, cancer requiring treatment, any drugs or comorbidities that may inhibit wound healing
  • Participation in any other clinical trial during participation in this trial
  • Life expectancy less than 1 year

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): NCT03469297


Contacts
Contact: Roy Martin 763-670-5600 rmartin@microoptx.com

Locations
United States, Minnesota
Minnesota Eye Consultants Recruiting
Bloomington, Minnesota, United States, 55431
Sponsors and Collaborators
MicroOptx

Responsible Party: MicroOptx
ClinicalTrials.gov Identifier: NCT03469297     History of Changes
Other Study ID Numbers: 4039
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases