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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 : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
MicroOptx

Tracking Information
First Submitted Date  ICMJE March 13, 2018
First Posted Date  ICMJE March 19, 2018
Last Update Posted Date August 15, 2018
Actual Study Start Date  ICMJE May 1, 2018
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2018)
  • Overall Responder Rate [ Time Frame: 6 Months ]
    Responder rate defined as achieving at least 20% reduction from baseline in intra-ocular pressure (IOP)
  • Adverse Event Rate [ Time Frame: 6 Months ]
    Rate of all AEs
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03469297 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2018)
  • Mean Change from Baseline in IOP [ Time Frame: 6 Months ]
  • Alternative Responder Rate [ Time Frame: 6 Months ]
    Responder rate defined as achieving follow-up IOP less than or equal to 14mmHg
  • Change in IOP-lowering Medications [ Time Frame: 6 Months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Feasibility Study of the Brown Glaucoma Implant in Patients With No Light Perceived
Official Title  ICMJE Early Feasibility Study of the Brown Glaucoma Implant in Patients With No Light Perceived
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glaucoma
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Brown Glaucoma Implant
Intervention: Device: Brown Glaucoma Implant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 13, 2018)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2020
Estimated Primary Completion Date November 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Roy Martin 763-670-5600 rmartin@microoptx.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03469297
Other Study ID Numbers  ICMJE 4039
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party MicroOptx
Study Sponsor  ICMJE MicroOptx
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account MicroOptx
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP