GlaucomaEarly BirdNCT03469297

Early Feasibility Study of the Brown Glaucoma Implant in Patients With Severe Visual Impairment or No Light Perceived

A study testing Brown Glaucoma Implant in people with Glaucoma, run by MicroOptx at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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 up to 10 subjects will be enrolled at three centers. Read more about this study

Who is it for?: Ages 22 years and older
Conditions the study is for: Glaucoma
What is being tested?: Brown Glaucoma Implant
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 8 participants
Where: 3 sitesUnited States
Study dates: 1 May 2018to 20 Sep 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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.
Best corrected visual acuity of 20/400 or worse.in the study eye.
Fellow eye with visually acuity of 20/200 or better and the visual field no worse than the study eye. If the study eye has no light perception, the fellow eye may have no light perception or better.
Intraocular pressure in the study eye greater than or equal to 21 mmHg and less than or equal to 50 mmHg.
Primary open-angle glaucoma (confirmed by gonioscopy).
Glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities: (1) Diffuse thinning, focal narrowing, or notching of the optic disc rim, especially at the inferior or superior poles with or without disc hemorrhage; (2) Localized abnormalities of the peripapillary retinal nerve fiber layer, especially at the inferior or superior poles; or (3) Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue.

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Humphrey Visual Field (HVF) demonstrating visual field defects consistent with glaucomatous optic nerve damage.
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.
Adequate space in the anterior chamber of the study eye sufficient to support implant with the BGI, defined as two contiguous clock hours of scleral spur visualization via goinioscopy, without compression, in the superior 180 degrees of the anterior angle.
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.
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.
Requirement of a combined glaucoma procedure in the study eye.

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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.
If both eyes of a prospective trial participant are eligible, only the eye with the highest intraocular pressure will be selected for implant.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Minnesota Eye Consultants
Bloomington, Minnesota, 55431
Glaucoma Associates of Texas
Dallas, Texas, 75231
iWorks Laser and Vision Center
Dayton, Ohio, 45405

Other trials in United States

About this study

Official title: Early Feasibility Study of the Brown Glaucoma Implant in Patients With No Light Perceived

Conditions: Glaucoma
Being tested: Brown Glaucoma Implant
Medical subject headings: Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Brown Glaucoma ImplantDevice
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 groups in NCT03469297
Study group	Role	What they receive
Brown Glaucoma Implant	Experimental	Not described Receives: Device: Brown Glaucoma Implant

What is being measured

The primary outcome is the main question the study is designed to answer.

Overall Responder Rate
Responder rate defined as achieving at least 20% reduction from baseline in intra-ocular pressure (IOP)
Measured: 6 Months
Adverse Event Rate
Rate of all AEs
Measured: 6 Months

Secondary outcomes (3)

Mean Change From Baseline in IOP
Mean change in diurnal IOP since the baseline visit
Measured: Baseline, 6 Months
Alternative Responder Rate
Responder rate defined as achieving follow-up IOP less than or equal to 14mmHg
Measured: 6 Months
Change in IOP-lowering Medications
Mean change in number of glaucoma medications since baseline
Measured: Baseline, 6 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 201820 Sep 2021

First posted19 Mar 2018
Study start1 May 2018
Primary completion26 Mar 2020
Study completion20 Sep 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for GlaucomaStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03469297
Sponsor's protocol ID: 4039
Acronym: Early Bird
Status last verified: Dec 2022
First submitted: 13 Mar 2018
Last updated: 28 Dec 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Early Feasibility Study of the Brown Glaucoma Implant in Patients With No Light Perceived
ClinicalTrials.gov ID: NCT03469297
Acronym / sponsor ID: Early Bird / 4039
Conditions: Glaucoma
Study type: Interventional
Recruitment status: Completed
Enrolment: 8 participants (actual)
Lead sponsor: MicroOptxIndustry (pharma, biotech, devices)
Study start: 1 May 2018 (actual)
Primary completion: 26 Mar 2020 (actual)
Study completion: 20 Sep 2021 (actual)
First posted: 19 Mar 2018 (actual)
Results: Posted 5 Dec 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Brown Glaucoma Implant	Experimental	Device: Brown Glaucoma Implant

Who may qualify

Ages: 22 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Age 22 years and older.
Best corrected visual acuity of 20/400 or worse.in the study eye.
Fellow eye with visually acuity of 20/200 or better and the visual field no worse than the study eye. If the study eye has no light perception, the fellow eye may have no light perception or better.
Intraocular pressure in the study eye greater than or equal to 21 mmHg and less than or equal to 50 mmHg.
Primary open-angle glaucoma (confirmed by gonioscopy).

Key exclusion criteria (15 listed)

Active Neovascular Glaucoma in the study eye.
Pigmentary Glaucoma in the study eye.
Pseudoexfoliative 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.

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
Brown Glaucoma ImplantThe 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.	Device	Brown Glaucoma Implant

Primary outcome

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

3 secondary outcomes

Mean Change From Baseline in IOP
Time frame: Baseline, 6 Months
Alternative Responder Rate
Time frame: 6 Months
Change in IOP-lowering Medications
Time frame: Baseline, 6 Months

Results and safety

Results posted to the registry on 5 Dec 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Brown Glaucoma Implant	8	7

Primary outcome: Overall Responder Rate

Time frame: 6 Months. Count of participants. Unit: Participants

Measure	Brown Glaucoma Implant n = 7
Value	3

Population analysed: Implanted subjects completing the 6-month visit.

Primary outcome: Adverse Event Rate

Time frame: 6 Months. Number. Unit: Events

Measure	Brown Glaucoma Implant n = 7
Adverse Events	66
Serious Adverse Events	8
Device-Related Adverse Events	31
Procedure-Related Adverse Events	12

Population analysed: Implanted subjects

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Brown Glaucoma Implant	4 of 7 (57.1%)	7 of 7 (100%)	2 of 7

Limitations and caveats (from the sponsor): Approximately 2 weeks after the initial implant, one subject (02-03) had the first BAM device explanted due to device channel blockage and elevated intra-ocular pressure. A second BAM device was implanted immediately after the explant procedure.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Brown Glaucoma Implant in people with Glaucoma, run by MicroOptx at 3 sites in United States.

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 11 inclusion and 15 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: finished, as of the sponsor's last update on 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. 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?

Yes. Results are posted in the registry (first posted 5 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Overall Responder Rate (time frame: 6 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?

On the ClinicalTrials.gov record for NCT03469297.

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 28 Dec 2022.