Angle-Closure, Glaucoma
Conditions
Brief summary
This study will evaluate the safety and IOP-lowering effectiveness of XEN in patients with Angle Closure Glaucoma.
Interventions
DEVICEXEN45
XEN45 unilaterally implanted in the study eye
Sponsors
Allergan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria: - Diagnosis of ACG defined as areas of iridotrabecular contact present in ≥ 2 quadrants and glaucomatous damage to optic disc and visual field, in the study eye - Study eye has healthy, free, and mobile conjunctiva in the target quadrant
Exclusion criteria
- Uncontrolled systemic disease (eg, diabetes, hypertension) - Known history of bleeding disorder or prolonged bleeding after surgery or those on pharmacologic blood thinners other than aspirin (up to 100 mg/day) - History of dermatologic keloid formation - Open angle glaucoma, active acute angle closure attack, congenital glaucoma, juvenile glaucoma, secondary glaucoma in the study eye - History of following surgeries in the study eye: o incisional refractive surgery (eg, radial keratotomy), other than astigmatic keratotomy or limbal relaxing incisions o corneal graft including partial grafts such as Descemet's stripping endothelial keratoplasty and Descemet's membrane endothelial keratoplasty o previous laser or incisional intraocular surgery that might interfere with the outcome of this trial - Previous glaucoma shunt implantation in the target quadrant in the study eye - Active or history of chronic uveitis in the study eye - Unable to discontinue contact lens wear in the study eye during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving at Least a 20% Reduction From Baseline Hour 0 IOP While on the Same Number or Fewer IOP Lowering Medications at Month 12 | Month 12 | IOP will be measured using a Goldmann applanation tonometer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline the Number of Concomitant IOP-lowering Medications | Month 12 | The number of concomitant IOP-lowering medications following implantation will be compared with the number prior to implantation. |
Countries
Australia, Canada, Singapore, South Korea, Taiwan, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| XEN45 Glaucoma Treatment System (Hereafter Referred to as XEN) XEN45 unilaterally implanted in the study eye | 62 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Death | 2 |
Baseline characteristics
| Characteristic | XEN45 Glaucoma Treatment System (Hereafter Referred to as XEN) |
|---|---|
| Age, Continuous | 68.0 years STANDARD_DEVIATION 9.64 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 62 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 31 Participants |
| Race (NIH/OMB) Black or African American | 1 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 | 30 Participants |
| Region of Enrollment Australia | 25 participants |
| Region of Enrollment Canada | 8 participants |
| Region of Enrollment Singapore | 10 participants |
| Region of Enrollment South Korea | 3 participants |
| Region of Enrollment Taiwan | 9 participants |
| Region of Enrollment United Kingdom | 7 participants |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 62 |
| other Total, other adverse events | 44 / 62 |
| serious Total, serious adverse events | 12 / 62 |
Outcome results
Primary
Percentage of Participants Achieving at Least a 20% Reduction From Baseline Hour 0 IOP While on the Same Number or Fewer IOP Lowering Medications at Month 12
IOP will be measured using a Goldmann applanation tonometer
Time frame: Month 12
Population: Implanted population, defined as all subjects implanted with XEN45, with data at visit. (Missing data and data after the 1st non-study surgical procedures for IOP control or device explant are not counted or imputed.)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| XEN45 Glaucoma Treatment System (Hereafter Referred to as XEN) | Percentage of Participants Achieving at Least a 20% Reduction From Baseline Hour 0 IOP While on the Same Number or Fewer IOP Lowering Medications at Month 12 | 80.5 percentage of participants |
Secondary
Change From Baseline the Number of Concomitant IOP-lowering Medications
The number of concomitant IOP-lowering medications following implantation will be compared with the number prior to implantation.
Time frame: Month 12
Population: Implanted population, defined as all subjects implanted with XEN45, with data at visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| XEN45 Glaucoma Treatment System (Hereafter Referred to as XEN) | Change From Baseline the Number of Concomitant IOP-lowering Medications | -1.6 Number of medications in study eye | Standard Deviation 1.33 |