Glaucoma
Conditions
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 up to 10 subjects will be enrolled at three centers. Subjects will be followed for 24 months, with the primary assessments completed 6 months after implant.
Interventions
DEVICEBrown 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.
Sponsors
MicroOptx
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 22 years and older. 2. Best corrected visual acuity of 20/400 or worse.in the study eye. 3. 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. 4. Intraocular pressure in the study eye greater than or equal to 21 mmHg and less than or equal to 50 mmHg. 5. Primary open-angle glaucoma (confirmed by gonioscopy). 6. 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. 7. Humphrey Visual Field (HVF) demonstrating visual field defects consistent with glaucomatous optic nerve damage. 8. 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. 9. 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. 10. Able and willing to comply with protocol requirements. 11. Able to understand and sign the Informed Consent form.
Exclusion criteria
1. Active Neovascular Glaucoma in the study eye. 2. Pigmentary Glaucoma in the study eye. 3. Pseudoexfoliative Glaucoma in the study eye. 4. 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. 5. Anticipated need for ocular surgery within one year in the study eye. 6. Requirement of a combined glaucoma procedure in the study eye. 7. Contact lens use in the study eye. 8. 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. 9. Other clinical conditions: 1. Poorly controlled diabetes (Type I or Type II) as determined by HbA1c \>8. 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. 10. Participation in any other clinical trial during participation in this trial. 11. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Responder Rate | 6 Months | Responder rate defined as achieving at least 20% reduction from baseline in intra-ocular pressure (IOP) |
| Adverse Event Rate | 6 Months | Rate of all AEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in IOP | Baseline, 6 Months | Mean change in diurnal IOP since the baseline visit |
| Alternative Responder Rate | 6 Months | Responder rate defined as achieving follow-up IOP less than or equal to 14mmHg |
| Change in IOP-lowering Medications | Baseline, 6 Months | Mean change in number of glaucoma medications since baseline |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Brown Glaucoma Implant 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. | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Brown Glaucoma Implant |
|---|---|
| Age, Continuous | 59.8 Years STANDARD_DEVIATION 12.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 7 |
| other Total, other adverse events | 7 / 7 |
| serious Total, serious adverse events | 4 / 7 |
Outcome results
Primary
Adverse Event Rate
Rate of all AEs
Time frame: 6 Months
Population: Implanted subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Brown Glaucoma Implant | Adverse Event Rate | Adverse Events | 66 Events |
| Brown Glaucoma Implant | Adverse Event Rate | Serious Adverse Events | 8 Events |
| Brown Glaucoma Implant | Adverse Event Rate | Device-Related Adverse Events | 31 Events |
| Brown Glaucoma Implant | Adverse Event Rate | Procedure-Related Adverse Events | 12 Events |
Primary
Overall Responder Rate
Responder rate defined as achieving at least 20% reduction from baseline in intra-ocular pressure (IOP)
Time frame: 6 Months
Population: Implanted subjects completing the 6-month visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brown Glaucoma Implant | Overall Responder Rate | 3 Participants |
Secondary
Alternative Responder Rate
Responder rate defined as achieving follow-up IOP less than or equal to 14mmHg
Time frame: 6 Months
Population: Implanted subjects who completed the month 6 follow-up visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brown Glaucoma Implant | Alternative Responder Rate | 3 Participants |
Secondary
Change in IOP-lowering Medications
Mean change in number of glaucoma medications since baseline
Time frame: Baseline, 6 Months
Population: Implanted subjects who completed the month 6 follow-up visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brown Glaucoma Implant | Change in IOP-lowering Medications | 0.6 Number of Glaucoma Medications | Standard Deviation 1.8 |
Secondary
Mean Change From Baseline in IOP
Mean change in diurnal IOP since the baseline visit
Time frame: Baseline, 6 Months
Population: Implanted subjects completing the 6-month visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brown Glaucoma Implant | Mean Change From Baseline in IOP | 8.3 mmHg | Standard Deviation 14.9 |