Glaucoma, Open-AngleEARLY BIRD EUNCT03634319
Early Evaluation of the Beacon Aqueous Microshunt in Patients Refractory to Drug Therapy in the European Union
A study testing Beacon Aqueous Microshunt in people with Glaucoma, Open-Angle, run by MicroOptx at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Glaucoma, Open-Angle
- What is being tested?
- Beacon Aqueous Microshunt
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Jun 2018to 8 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 22 years and older.
- Diagnosed with mild, moderate or severe open-angle glaucoma (OAG).
- Best corrected vision acuity 20/25 or worse in the study eye.
- Inadequate medical control of IOP, or target IOP not reached with intraocular pressure in the study eye greater than or equal to 20 mmHg.
- At least two contiguous clock hours of intact conjunctiva near the limbus between clock hours of 09:00 and 03:00 in the study eye.
- Adequate space in the anterior chamber of the study eye sufficient to support implant with the BAM, defined as two contiguous clock hours of scleral spur visualization via gonioscopy, without compression, in the superior 180 degrees of the anterior angle.
Show all 9Show fewer
- Any IOP-lowering medications should be stabilized at least 30 days prior to baseline measurements.
- Able and willing to comply with protocol requirements.
- Able to understand and sign the Informed Consent form.
Who cannot join
- Active Neovascular Glaucoma in the study eye.
- Pigmentary Glaucoma in the study eye.
- Pseudoexfoliative Glaucoma in the study eye.
- Any eye disease associated with the formation of free-floating material or tissue in the anterior chamber of the 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.
Show all 18Show fewer
- Contact lens use in the study eye.
- 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.
- Other clinical conditions:
- Poorly controlled diabetes (Type I or Type II) as determined by HbA1c >8.
- Cancer requiring treatment during the duration of the study.
- Any drugs (e.g.: immunosuppressive drugs) or co- morbidity that might inhibit wound healing.
- Participation in any other clinical trial during participation in this trial.
- Life expectancy <1 year.
- Clinically significant macular degeneration in the study eye.
- Patients who have undergone surgery in the trial eye within the last 6 months.
- Planned combined cataract surgery.
- If both eyes of a prospective trial participant are eligible, the eye with the highest intraocular pressure will be selected for implant.
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
University Eye Hospital
Bochum
Universitatsklinikum Schleswig-Holstein
Lübeck, 23538
About this study
Official title: Early Evaluation of the Brown Glaucoma Implant in Patients Refractory to Drug Therapy in the European Union
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.
- Conditions
- Glaucoma, Open-Angle
- Being tested
- Beacon Aqueous Microshunt
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beacon Aqueous MicroshuntDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in IOP
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.
Measured: 12 Months
Adverse Event Rate
Rate of all AEs
Measured: 12 Months
Secondary outcomes (3)
Mean Change from Baseline in IOP
Change in IOP at follow-up compared to baseline
Measured: 12 Months
Responder Rate for 20% reduction
Defined as a subject achieving at least 20% reduction from baseline in IOP
Measured: 12 Months
Reduction in IOP lowering medication
Change in number of medications at follow-up compared to baseline
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start1 Jun 2018
- Primary completion11 Nov 2021
- Study completion8 Jan 2023
Why it stopped: Significant risks (e.g., infection, endothelial cell loss) and high rate of channel plugging associated with product use.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- MicroOptx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03634319
- Sponsor's protocol ID
- 4004-22
- Acronym
- EARLY BIRD EU
- Status last verified
- Jan 2023
- First submitted
- 25 Jun 2018
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Evaluation of the Brown Glaucoma Implant in Patients Refractory to Drug Therapy in the European Union
- ClinicalTrials.gov ID
- NCT03634319
- Acronym / sponsor ID
- EARLY BIRD EU / 4004-22
- Conditions
- Glaucoma, Open-Angle
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Significant risks (e.g., infection, endothelial cell loss) and high rate of channel plugging associated with product use.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- MicroOptxIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 11 Nov 2021 (actual)
- Study completion
- 8 Jan 2023 (actual)
- First posted
- 16 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- 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.
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 22 years and older.
- Diagnosed with mild, moderate or severe open-angle glaucoma (OAG).
- Best corrected vision acuity 20/25 or worse in the study eye.
- Inadequate medical control of IOP, or target IOP not reached with intraocular pressure in the study eye greater than or equal to 20 mmHg.
- At least two contiguous clock hours of intact conjunctiva near the limbus between clock hours of 09:00 and 03:00 in the study eye.
Key exclusion criteria (18 listed)
- Active Neovascular Glaucoma in the study eye.
- Pigmentary Glaucoma in the study eye.
- Pseudoexfoliative Glaucoma in the study eye.
- Any eye disease associated with the formation of free-floating material or tissue in the anterior chamber of the 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beacon Aqueous MicroshuntThe 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. | Device | – |
Primary outcome
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.
Adverse Event Rate
Time frame: 12 Months
Rate of all AEs
3 secondary outcomes
Mean Change from Baseline in IOP
Time frame: 12 Months
Responder Rate for 20% reduction
Time frame: 12 Months
Reduction in IOP lowering medication
Time frame: 12 Months
Results and safety
The study was stopped early (reason given: Significant risks (e.g., infection, endothelial cell loss) and high rate of channel plugging associated with product use.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Glaucoma, Open-Angle
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beacon Aqueous Microshunt in people with Glaucoma, Open-Angle, run by MicroOptx at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Significant risks (e.g., infection, endothelial cell loss) and high rate of channel plugging associated with product use.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in IOP (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.