Open-angle Glaucoma
Conditions
Keywords
Glaucoma
Brief summary
The purpose of this study is to assess the safety and effectiveness of the Hydrus Microstent in patients with refractory open-angle glaucoma.
Detailed description
Participants will attend a screening visit, a baseline visit, a surgery visit, and 8 post-operative visits (Day 1, Day 7, Month 1, Month 2, Month 3, Month 6, Month 9, Month 12), for a total individual duration of approximately 14 months.
Interventions
DEVICEHydrus Microstent
Device implanted into the Schlemm's canal of the eye to provide a natural outflow pathway for aqueous humor, leading to a reduction in intraocular pressure (IOP). The Hydrus Microstent is intended for lifetime use of the glaucoma patient.
PROCEDUREOphthalmic surgery
Implantation of the Hydrus Microstent performed under either local or topical ophthalmic anesthesia
Sponsors
Ivantis, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Open-angle glaucoma with optic nerve pathology; * BCVA of 20/80 or better in study eye; * Refractory glaucoma; * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Secondary glaucoma other than pseudoexfoliative and pigmentary glaucoma; * Acute angle closure, chronic angle closure, or congenial, malignant, or developmental glaucoma; * Pre-perimetric glaucoma; * Ocular hypertension * Shallow or flat anterior chamber; * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Greater Than or Equal to a 20 Percent Decrease From Baseline in Mean Diurnal Intraocular Pressure (MDIOP) at Month 12 While Maintaining the Same or Fewer Number of Medications as at Baseline | Baseline, Month 12 | Intraocular pressure was measured using Goldmann Applanation tonometry. Three separate IOP measurements were taken over an 8-hour period and averaged together to achieve mean diurnal intraocular pressure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in MDIOP at Month 12 | Baseline, Month 12 | Intraocular pressure was measured using Goldmann Applanation tonometry and recorded in millimeters mercury (mmHG). Three separate IOP measurements were taken over an 8-hour period and averaged together to achieve mean diurnal intraocular pressure. A negative number represents a reduction from baseline. For non-responders, data was imputed as specified in the protocol. No hypothesis testing was pre-specified for this outcome measure. |
Countries
Colombia, Philippines, Spain, United Kingdom, United States
Participant flow
Recruitment details
Participants were recruited from 20 investigative sites located in the United States (16), Philippines (1), Spain (1), United Kingdom (1), and Colombia (1).
Pre-assignment details
Of the 217 subjects who signed an informed consent, 117 were exited from the study prior to attempted implantation as screen failures. This reporting group includes all subjects for whom a Hydrus Microstent was implanted or implantation was attempted (100) (Safety Analysis Population).
Participants by arm
| Arm | Count |
|---|---|
| Hydrus Microstent Hydrus Microstent implanted in the eye per the supplied Hydrus Microstent Instructions for Use and associated training, Only one eye (study eye) was implanted. | 100 |
| Total | 100 |
Baseline characteristics
| Characteristic | Hydrus Microstent |
|---|---|
| Age, Continuous | 71.3 years STANDARD_DEVIATION 10 |
| Age, Customized 60 years to less than 70 years | 28 participants |
| Age, Customized 70 to less than 80 years | 35 participants |
| Age, Customized 80 years and greater | 24 participants |
| Age, Customized Less than 60 years | 13 participants |
| Race/Ethnicity, Customized Asian | 7 Participants |
| Race/Ethnicity, Customized Black or African American | 14 Participants |
| Race/Ethnicity, Customized Mestizo | 2 Participants |
| Race/Ethnicity, Customized Refuses to Answer/Unknown | 3 Participants |
| Race/Ethnicity, Customized White | 74 Participants |
| Sex: Female, Male Female | 52 Participants |
| Sex: Female, Male Male | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 100 | 0 / 100 |
| other Total, other adverse events | 55 / 100 | 0 / 100 |
| serious Total, serious adverse events | 5 / 100 | 0 / 100 |
Outcome results
Primary
Percentage of Subjects With Greater Than or Equal to a 20 Percent Decrease From Baseline in Mean Diurnal Intraocular Pressure (MDIOP) at Month 12 While Maintaining the Same or Fewer Number of Medications as at Baseline
Intraocular pressure was measured using Goldmann Applanation tonometry. Three separate IOP measurements were taken over an 8-hour period and averaged together to achieve mean diurnal intraocular pressure.
Time frame: Baseline, Month 12
Population: Effectiveness Population: All subjects who undergo the Hydrus implantation surgery and are not discontinued early from the study due to unrelated reasons such as death or relocation. For non-responders, data was imputed as specified in the protocol. No hypothesis testing was pre-specified for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hydrus Microstent | Percentage of Subjects With Greater Than or Equal to a 20 Percent Decrease From Baseline in Mean Diurnal Intraocular Pressure (MDIOP) at Month 12 While Maintaining the Same or Fewer Number of Medications as at Baseline | 43.0 percentage of subjects |
Secondary
Mean Change From Baseline in MDIOP at Month 12
Intraocular pressure was measured using Goldmann Applanation tonometry and recorded in millimeters mercury (mmHG). Three separate IOP measurements were taken over an 8-hour period and averaged together to achieve mean diurnal intraocular pressure. A negative number represents a reduction from baseline. For non-responders, data was imputed as specified in the protocol. No hypothesis testing was pre-specified for this outcome measure.
Time frame: Baseline, Month 12
Population: Effectiveness Population: All subjects who undergo the Hydrus implantation surgery and are not discontinued early from the study due to unrelated reasons such as death or relocation. For non-responders, data was imputed as specified in the protocol. No hypothesis testing was pre-specified for this outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hydrus Microstent | Mean Change From Baseline in MDIOP at Month 12 | -3.77 mmHG | Standard Deviation 5 |