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Trial record 1 of 3 for:    microoptx | glaucoma
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Study of the Beacon Aqueous Microshunt in Patients With Refractory Glaucoma (Beacon)

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: NCT04072016
Recruitment Status : Active, not recruiting
First Posted : August 28, 2019
Last Update Posted : February 17, 2022
Sponsor:
Information provided by (Responsible Party):
MicroOptx

Tracking Information
First Submitted Date  ICMJE August 26, 2019
First Posted Date  ICMJE August 28, 2019
Last Update Posted Date February 17, 2022
Actual Study Start Date  ICMJE April 29, 2020
Estimated Primary Completion Date July 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2022)
  • Effectiveness via Intraocular Pressure Reduction [ Time Frame: 12 Months ]
    20% mean diurnal IOP reduction from baseline, on the same number or fewer topical IOP-lowering medications
  • Safety via Serious and Adverse Event Reporting [ Time Frame: 12 Months ]
    Rate of occurrence of serious procedure-related and/or device-related adverse events.
Original Primary Outcome Measures  ICMJE
 (submitted: August 26, 2019)
  • Effectiveness [ Time Frame: 12 Months ]
    20% mean diurnal IOP reduction from baseline, on the same number or fewer topical IOP-lowering medications
  • Safety [ Time Frame: 12 Months ]
    Rate of occurrence of serious procedure-related and/or device-related adverse events.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2022)
  • Responder rate defined as achieving at least 20% mean diurnal IOP reduction from baseline [ Time Frame: 12 Months ]
  • Mean Change from baseline in IOP [ Time Frame: 12 Months ]
  • Schirmer tear test - Mean change from baseline [ Time Frame: 12 Months ]
  • Proportion of Eyes Achieving Specific IOP Targets (≤18 mmHg, ≤17 mmHg, ≤16 mmHg, ≤15 mmHg, ≤14 mmHg, ≤13 mmHg, and ≤12 mmHg) compared to baseline [ Time Frame: 12 Months ]
  • Number of topical IOP-lowering medications - Mean change from baseline [ Time Frame: 12 Months ]
  • Kaplan-Meier Analysis of Failure [ Time Frame: 12 Months ]
    Glaucoma-related secondary surgical intervention with or without device explant, device explant alone, or not achieving >20% IOP reduction on the same number of medications or fewer
  • Rate of ocular and non-ocular adverse events [ Time Frame: 12 Months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 26, 2019)
  • Responder rate defined as achieving at least 20% mean diurnal IOP reduction from baseline [ Time Frame: 12 Months ]
  • Mean Change from baseline in IOP [ Time Frame: 12 Months ]
  • Schirmer tear test - mean change from baseline [ Time Frame: 12 Months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Beacon Aqueous Microshunt in Patients With Refractory Glaucoma
Official Title  ICMJE The Beacon Study: A Prospective, Multicenter Study to Evaluate the Safety and Effectiveness of Beacon Aqueous Microshunt for Refractory Glaucoma
Brief Summary This is a prospective, multicenter, single-arm clinical study to evaluate the safety and effectiveness of Beacon Aqueous Microshunt in patients with refractory glaucoma.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glaucoma
Intervention  ICMJE Device: Beacon Aqueous Microshunt
The Beacon Aqueous Microshunt (BAM) is an implantable device intended to reduce intraocular pressure (IOP) in patients with refractory glaucoma by shunting aqueous humor from the anterior chamber to the surface of the eye.
Study Arms  ICMJE Experimental: Beacon Aqueous Microshunt
Intervention: Device: Beacon Aqueous Microshunt
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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: August 26, 2019)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2022
Estimated Primary Completion Date July 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age 22-85 years.
  2. Refractory glaucoma: Prior failure of filtering/cilioablative procedure and/or uncontrolled IOP on maximum-tolerated medication (i.e. >=4 classes of topical lowering medications, or fewer in the case of tolerability or efficacy issues).
  3. Primary open-angle, traumatic or neovascular glaucoma.
  4. Medicated DIOP ≥20 mmHg and ≤45 mmHg on maximum-tolerated medical therapy. Note: No washout; medications stabilized 30 days prior to assessment.
  5. Baseline BCVA of light perception or better in study eye.
  6. Visual field defects consistent with glaucomatous optic nerve damage.
  7. Glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities:

    • Diffuse thinning, focal narrowing, or notching of the optic disc rim, especially at the inferior or superior poles with or without disc hemorrhage;
    • Localized abnormalities of the peripapillary retinal nerve fiber layer, especially at the inferior or superior poles; or
    • Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue 8. Visual field mean deviation (MD) by Humphrey Visual Field: Visual field defects consistent with glaucomatous optic nerve damage and mean deviation worse than -3 dB in the study eye; and at least one of the following two findings:
    • A cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level on the pattern deviation (PD) plot; and/or
    • Glaucoma hemi-field test "outside normal limits".

9. At least two contiguous clock hours of intact conjunctiva near the limbus between clock hours of 9:00 and 03:00 in the study eye.

10. Adequate space in the anterior chamber by Spaeth Grade C, D or E for iris insertion (with indentation).

11. Participant has the understanding, ability, and willingness to fully comply with study procedures and postoperative care instructions.

12. Participant understands and signs the informed consent.

Exclusion Criteria:

  1. No light perception vision.
  2. Conditions of active neovascular conditions, such as active iris or corneal neovascularization, or active proliferative retinopathy in study eye.
  3. Pigmentary glaucoma in study eye.
  4. Pseudoexfoliation syndrome in study eye.
  5. Angle-closure glaucoma in study eye.
  6. Iridocorneal endothelial syndrome in study eye.
  7. Uveitic glaucoma in the study eye.
  8. Epithelial or fibrous downgrowth in the study eye.
  9. Best corrected visual acuity (BCVA) worse than 20/200 in the non-study eye.
  10. Corneal conditions in study eye inhibiting normal incisional healing (e.g. Fuch's dystrophy) or impair visualization of implant inside the anterior chamber.
  11. Prior intraocular surgery in study eye within ≤6 months before the preoperative visit (including phacoemulsification).
  12. Central corneal endothelial cell count of less than 1600 cells/mm2 in the study eye.
  13. Anticipated need for ocular surgery or retinal laser procedure in the study eye within the 12-month follow-up period.
  14. Need for glaucoma surgery combined with other ocular procedures in the study eye at time of implant (e.g. cataract surgery, penetrating keratoplasty, or retinal surgery).
  15. Unwilling to discontinue contact lens use in the study eye after surgery.
  16. Central corneal thickness ≤490μm or ≥620μm.
  17. 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.
  18. Any condition that prevents the device implantation in the superior region of the study eye.
  19. Vitreous in the anterior chamber for which a vitrectomy is anticipated.
  20. Functionally significant cataract in the study eye.
  21. Other clinical conditions:

    1. Poorly controlled diabetes (Type I or Type II) as determined by HbA1c >8 within 3 months of implant.
    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.
  22. Participation in any other clinical study during participation in this study.
  23. Engage in activities that involve submerging their head under water, such as diving or swimming.
  24. Women who are (i) pregnant, (ii) nursing, (iii) planning a pregnancy and (iv) of childbearing potential not using a reliable method of contraception.
  25. Life expectancy <1 year.

If both eyes are eligible, the eye with the worse BCVA will be selected.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04072016
Other Study ID Numbers  ICMJE 4046
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 Not Provided
Current Responsible Party MicroOptx
Original Responsible Party Same as current
Current Study Sponsor  ICMJE MicroOptx
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account MicroOptx
Verification Date February 2022

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