Trial Outcomes & Findings for Early Feasibility Study of the Brown Glaucoma Implant in Patients With Severe Visual Impairment or No Light Perceived (NCT NCT03469297)
NCT ID: NCT03469297
Last Updated: 2022-12-28
Results Overview
Responder rate defined as achieving at least 20% reduction from baseline in intra-ocular pressure (IOP)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
6 Months
Results posted on
2022-12-28
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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8
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Overall Study
COMPLETED
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7
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Early Feasibility Study of the Brown Glaucoma Implant in Patients With Severe Visual Impairment or No Light Perceived
Baseline characteristics by cohort
| Measure |
Brown Glaucoma Implant
n=8 Participants
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.
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Age, Continuous
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59.8 Years
STANDARD_DEVIATION 12.8 • n=5 Participants
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Sex: Female, Male
Female
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3 Participants
n=5 Participants
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Sex: Female, Male
Male
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5 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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8 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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4 Participants
n=5 Participants
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Race (NIH/OMB)
White
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4 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
United States
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8 participants
n=5 Participants
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PRIMARY outcome
Timeframe: 6 MonthsPopulation: Implanted subjects completing the 6-month visit.
Responder rate defined as achieving at least 20% reduction from baseline in intra-ocular pressure (IOP)
Outcome measures
| Measure |
Brown Glaucoma Implant
n=7 Participants
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.
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Overall Responder Rate
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3 Participants
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PRIMARY outcome
Timeframe: 6 MonthsPopulation: Implanted subjects
Rate of all AEs
Outcome measures
| Measure |
Brown Glaucoma Implant
n=7 Participants
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.
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|---|---|
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Adverse Event Rate
Serious Adverse Events
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8 Events
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Adverse Event Rate
Device-Related Adverse Events
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31 Events
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Adverse Event Rate
Procedure-Related Adverse Events
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12 Events
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Adverse Event Rate
Adverse Events
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66 Events
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SECONDARY outcome
Timeframe: Baseline, 6 MonthsPopulation: Implanted subjects completing the 6-month visit.
Mean change in diurnal IOP since the baseline visit
Outcome measures
| Measure |
Brown Glaucoma Implant
n=7 Participants
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.
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Mean Change From Baseline in IOP
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8.3 mmHg
Standard Deviation 14.9
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SECONDARY outcome
Timeframe: 6 MonthsPopulation: Implanted subjects who completed the month 6 follow-up visit
Responder rate defined as achieving follow-up IOP less than or equal to 14mmHg
Outcome measures
| Measure |
Brown Glaucoma Implant
n=7 Participants
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.
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Alternative Responder Rate
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3 Participants
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SECONDARY outcome
Timeframe: Baseline, 6 MonthsPopulation: Implanted subjects who completed the month 6 follow-up visit
Mean change in number of glaucoma medications since baseline
Outcome measures
| Measure |
Brown Glaucoma Implant
n=7 Participants
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.
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Change in IOP-lowering Medications
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0.6 Number of Glaucoma Medications
Standard Deviation 1.8
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Adverse Events
Brown Glaucoma Implant
Serious events: 4 serious events
Other events: 7 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Brown Glaucoma Implant
n=7 participants at risk
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.
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Cardiac disorders
Atypical Chest Pain
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14.3%
1/7 • Number of events 1 • 24 months
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Psychiatric disorders
Mental Health Crisis Evaluation
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14.3%
1/7 • Number of events 1 • 24 months
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Eye disorders
Increased Intra-Ocular Pressure
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14.3%
1/7 • Number of events 1 • 24 months
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Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
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14.3%
1/7 • Number of events 1 • 24 months
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Musculoskeletal and connective tissue disorders
Left Knee Replacement
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14.3%
1/7 • Number of events 1 • 24 months
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Gastrointestinal disorders
Gastrointestinal Bleed
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14.3%
1/7 • Number of events 1 • 24 months
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Cardiac disorders
Myocardial Infarction
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14.3%
1/7 • Number of events 1 • 24 months
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Injury, poisoning and procedural complications
Motor Vehicle Accident
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14.3%
1/7 • Number of events 1 • 24 months
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Cardiac disorders
Cardiac Arrest
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14.3%
1/7 • Number of events 1 • 24 months
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Other adverse events
| Measure |
Brown Glaucoma Implant
n=7 participants at risk
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.
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Eye disorders
Anterior Chamber Flare
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14.3%
1/7 • Number of events 2 • 24 months
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Eye disorders
Blurred Vision
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14.3%
1/7 • Number of events 1 • 24 months
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Cardiac disorders
Chest Pain
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14.3%
1/7 • Number of events 1 • 24 months
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Eye disorders
Chalazion
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14.3%
1/7 • Number of events 1 • 24 months
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Eye disorders
Choroidal Detachment
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14.3%
1/7 • Number of events 1 • 24 months
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Eye disorders
Conjunctivitis/Conjunctival Injection
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71.4%
5/7 • Number of events 8 • 24 months
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Eye disorders
Corneal Abrasion
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28.6%
2/7 • Number of events 2 • 24 months
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Eye disorders
Corneal Edema
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14.3%
1/7 • Number of events 1 • 24 months
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Eye disorders
Diminished/No Flow through BAM Device Channel
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42.9%
3/7 • Number of events 9 • 24 months
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Eye disorders
Eye Dryness/Discomfort/Irritation
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28.6%
2/7 • Number of events 5 • 24 months
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General disorders
Epistaxis
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14.3%
1/7 • Number of events 1 • 24 months
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Skin and subcutaneous tissue disorders
Folliculitis - Trunk
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14.3%
1/7 • Number of events 1 • 24 months
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Eye disorders
Increased Intra-Ocular Pressure
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85.7%
6/7 • Number of events 12 • 24 months
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Eye disorders
Iris Nevus
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14.3%
1/7 • Number of events 1 • 24 months
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Surgical and medical procedures
Knee Surgery
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14.3%
1/7 • Number of events 1 • 24 months
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General disorders
Migraine Headache
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14.3%
1/7 • Number of events 1 • 24 months
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Eye disorders
Ocular Allergies
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28.6%
2/7 • Number of events 3 • 24 months
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Eye disorders
Posterior Capsular Opacification
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14.3%
1/7 • Number of events 1 • 24 months
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Surgical and medical procedures
Bleeding During Implant Procedure
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14.3%
1/7 • Number of events 1 • 24 months
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General disorders
Sinusitis
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14.3%
1/7 • Number of events 3 • 24 months
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Injury, poisoning and procedural complications
Skin Lesion - Forearm
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14.3%
1/7 • Number of events 1 • 24 months
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Eye disorders
Superficial Punctate Keratitis
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28.6%
2/7 • Number of events 3 • 24 months
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Eye disorders
Tenon Cyst
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14.3%
1/7 • Number of events 1 • 24 months
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Eye disorders
Unilateral Icteric Sclera
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14.3%
1/7 • Number of events 1 • 24 months
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Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
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14.3%
1/7 • Number of events 1 • 24 months
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Eye disorders
Vessels on Endothelium
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14.3%
1/7 • Number of events 1 • 24 months
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Eye disorders
Eye Watering
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14.3%
1/7 • Number of events 1 • 24 months
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Eye disorders
Eye Feels Tired
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14.3%
1/7 • Number of events 1 • 24 months
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60