Primary Open Angle Glaucoma
Conditions
Keywords
Glaucoma, POAG, Cataract
Brief summary
This clinical trial is a prospective, randomized, controlled, multicenter, study. After informed consent is obtained, patients will be evaluated for eligibility based on glaucoma severity, eye health, and visual acuity. Following successful screening, use of all topical glaucoma medications will be stopped for a period of washout to establish a qualifying medication-free intraocular pressure (IOP) value. Clinical follow up will be scheduled over the course of the 24 month study, and examinations will be repeated to monitor eye health. At the 1 and 2 year follow up, those patients on ocular hypotensive medications will be instructed to washout, and then have the diurnal (IOP taken in the morning, mid-day, and afternoon in the same day) IOP evaluation. Annual follow up will occur up to 5 years. The primary effectiveness endpoint is a decrease in diurnal IOP from baseline compared to the 24 months diurnal IOP following medication washout.
Interventions
DEVICEHydrus Aqueous Implant
The Hydrus Aqueous Implant is a crescent-shaped nitinol device intended to be a permanent implant placed through the trabecular meshwork into Schlemm's Canal, immediately following placement of a monofocal IOL.
PROCEDURECataract surgery
A monofocal intraocular lens (IOL) placed during the cataract surgery.
Sponsors
Ivantis, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* An operable age-related cataract * A diagnosis of POAG treated with 1 to 4 hypotensive medications * Medicated IOP ≤ 31 mmHg * Diurnal IOP ≥ 22 mmHg and ≤ 34 mmHg
Exclusion criteria
* Congenital or developmental glaucoma * Previous argon laser trabeculoplasty * Ab-interno or ab-externo device implanted in or through Schlemm's Canal * Use of oral hypotensive medication for glaucoma for treatment of fellow eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Mean Diurnal IOP From Baseline at 24 Months Following Medication Washout. | Baseline and 24 months | Percentage of eyes in which diurnal IOP was reduced by greater than or equal to 20% at 24 months postoperative compared to baseline after washout of topical glaucoma medications. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Diurnal Washed Out IOP Change From Baseline at 24 Months Compared Between Treatment and Control Groups. | Baseline and 24 months | Mean diurnal IOP change from baseline at 24 months between both groups after washout of topical glaucoma medications. |
Countries
Canada, Germany, Italy, Mexico, Philippines, Poland, Spain, United Kingdom, United States
Participant flow
Recruitment details
Patients were screened and enrolled at 38 investigational sites in the United States and other countries.
Pre-assignment details
Of the 1,143 enrolled, 572 were screen failures and 15 were excluded intraoperatively due to failure to meet all intraoperative eligibility criteria. At the time of reporting, 556 patients randomized are available for analysis.
Participants by arm
| Arm | Count |
|---|---|
| Hydrus Aqueous Implant (Treatment) Cataract surgery plus Hydrus Aqueous Implant
Hydrus Aqueous Implant: The Hydrus Aqueous Implant is a crescent-shaped nitinol device intended to be a permanent implant placed through the trabecular meshwork into Schlemm's Canal, immediately following placement of a monofocal IOL. | 369 |
| Cataract Surgery (Control) Cataract surgery only
Cataract surgery: A monofocal intraocular lens (IOL) placed during the cataract surgery. | 187 |
| Total | 556 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 5 | 5 |
| Overall Study | Lost to Follow-up | 7 | 12 |
Baseline characteristics
| Characteristic | Cataract Surgery (Control) | Total | Hydrus Aqueous Implant (Treatment) |
|---|---|---|---|
| Age, Continuous | 71.2 years STANDARD_DEVIATION 7.6 | 71.1 years STANDARD_DEVIATION 7.8 | 71.1 years STANDARD_DEVIATION 7.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 19 Participants | 43 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 168 Participants | 513 Participants | 345 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 11 Participants | 32 Participants | 21 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 60 Participants | 45 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 20 Participants | 12 Participants |
| Race (NIH/OMB) White | 153 Participants | 444 Participants | 291 Participants |
| Sex: Female, Male Female | 105 Participants | 311 Participants | 206 Participants |
| Sex: Female, Male Male | 82 Participants | 245 Participants | 163 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 369 | 5 / 187 |
| other Total, other adverse events | 106 / 369 | 24 / 187 |
| serious Total, serious adverse events | 10 / 369 | 6 / 187 |
Outcome results
Primary
Reduction in Mean Diurnal IOP From Baseline at 24 Months Following Medication Washout.
Percentage of eyes in which diurnal IOP was reduced by greater than or equal to 20% at 24 months postoperative compared to baseline after washout of topical glaucoma medications.
Time frame: Baseline and 24 months
Population: Intent-to-Treat (ITT)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hydrus Aqueous Implant (Treatment) | Reduction in Mean Diurnal IOP From Baseline at 24 Months Following Medication Washout. | 77.2 percentage of eyes |
| Cataract Surgery (Control) | Reduction in Mean Diurnal IOP From Baseline at 24 Months Following Medication Washout. | 57.8 percentage of eyes |
Secondary
Mean Diurnal Washed Out IOP Change From Baseline at 24 Months Compared Between Treatment and Control Groups.
Mean diurnal IOP change from baseline at 24 months between both groups after washout of topical glaucoma medications.
Time frame: Baseline and 24 months
Population: Intent-to-Treat (ITT)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hydrus Aqueous Implant (Treatment) | Mean Diurnal Washed Out IOP Change From Baseline at 24 Months Compared Between Treatment and Control Groups. | -7.5 mmHg | Standard Deviation 4.1 |
| Cataract Surgery (Control) | Mean Diurnal Washed Out IOP Change From Baseline at 24 Months Compared Between Treatment and Control Groups. | -5.3 mmHg | Standard Deviation 3.9 |