Primary Open Angle Glaucoma
Conditions
Keywords
XEN, Primary Open Angle Glaucoma, Filtration Device, Ab interno
Brief summary
The objective of this study was to evaluate the AqueSys XEN Implant \[XEN® Gel Stent (XEN45 Implant)\] for the treatment of moderate primary open angle glaucoma (POAG) participants when medications have failed to control intraocular pressure (IOP). Effectiveness was evaluated by comparing medicated preoperative IOP to postoperative values. Additionally, the number of topical IOP-lowering medications at screening were compared to the number of IOP-lowering medications at 1 year.
Interventions
DEVICEXEN® Gel Stent
The XEN® Gel Stent (XEN45 implant) was placed in the study eye.
PROCEDURECataract Surgery
Participants diagnosed with a cataract elected to have cataract surgery.
Sponsors
AqueSys, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of primary open angle glaucoma * Participants are taking at least one and no more than four topical IOP-lowering medications.
Exclusion criteria
* Angle Closure Glaucoma * Participant has neovascular, uveitic or angle recession glaucoma or any glaucoma associated with vascular disorders * Clinically significant inflammation or infection in the study eye within 30 days prior to the preoperative visit (e.g., blepharitis, conjunctivitis, keratitis, uveitis, herpes simplex infection) * Presence of conjunctival scarring or prior conjunctival surgery or other conjunctival pathologies (e.g., pterygium) in the target quadrant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Intraocular Pressure (IOP) in the Study Eye to Month 12 | Baseline (≤ 90 days Preoperative) to Month 12 (Postoperative) | IOP is a measurement of the fluid pressure inside the eye. Two IOP measurements were taken, followed by a third if the first 2 differed by 3 mmHg or more. The measurements were averaged. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement. |
| Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 12 | Baseline (≤ 90 days Preoperative) to Month 12 (Postoperative) | The use of topical IOP-lowering medications was recorded at the preoperative screening visit and at the 12 Month postoperative visit. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement. |
| Mean Change From Baseline in IOP in the Study Eyes to Month 24 | Baseline (≤ 90 days Preoperative) to Month 24 (Postoperative) | IOP is a measurement of the fluid pressure inside the eye. Two IOP measurements were taken, followed by a third if the first 2 differed by 3 mmHg or more. The measurements were averaged. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement. |
| Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 24 | Baseline (≤ 90 days Preoperative) to Month 24 (Postoperative) | The use of topical IOP-lowering medications was recorded at the preoperative screening visit and at the 24 Month postoperative visit. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement. |
Countries
Austria, Belgium, Germany, Italy, Poland, Spain, Switzerland, United Kingdom, Venezuela
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| XEN® Gel Stent The XEN® Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure. | 106 |
| XEN® Gel Stent The XEN® Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure. | 114 |
| XEN® Gel Stent With Cataract Surgery The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract. | 79 |
| XEN® Gel Stent With Cataract Surgery The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract. | 88 |
| Total | 387 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Another Glaucoma-related Surgery | 12 | 1 |
| Overall Study | Death | 2 | 2 |
| Overall Study | Lost to Follow-up | 4 | 1 |
| Overall Study | No Reason Specified | 6 | 8 |
| Overall Study | Patient Decision | 4 | 0 |
| Overall Study | XEN Implant Explantation | 0 | 1 |
Baseline characteristics
| Characteristic | XEN® Gel Stent | XEN® Gel Stent With Cataract Surgery | Total |
|---|---|---|---|
| Age, Continuous | 68.3 years STANDARD_DEVIATION 11.7 | 76.5 years STANDARD_DEVIATION 6.1 | 71.8 years STANDARD_DEVIATION 10.5 |
| Race/Ethnicity, Customized Asian | 1 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 103 Participants | 75 Participants | 178 Participants |
| Sex: Female, Male Female | 55 Participants | 40 Participants | 95 Participants |
| Sex: Female, Male Male | 51 Participants | 39 Participants | 90 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 112 | 2 / 87 |
| other Total, other adverse events | 14 / 120 | 8 / 98 |
| serious Total, serious adverse events | 12 / 120 | 6 / 98 |
Outcome results
Primary
Change From Baseline in Mean Intraocular Pressure (IOP) in the Study Eye to Month 12
IOP is a measurement of the fluid pressure inside the eye. Two IOP measurements were taken, followed by a third if the first 2 differed by 3 mmHg or more. The measurements were averaged. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.
Time frame: Baseline (≤ 90 days Preoperative) to Month 12 (Postoperative)
Population: mITT Population included all eligible eyes that met IOP and IOP-lowering medication inclusion criteria and received the XEN45 implant. Number analyzed is the number of eyes with data at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| XEN® Gel Stent | Change From Baseline in Mean Intraocular Pressure (IOP) in the Study Eye to Month 12 | Baseline (preoperation) | 21.7 mmHg | Standard Deviation 3.76 |
| XEN® Gel Stent | Change From Baseline in Mean Intraocular Pressure (IOP) in the Study Eye to Month 12 | Change from Baseline to Month 12 | -6.6 mmHg | Standard Deviation 5.64 |
| XEN® Gel Stent With Cataract Surgery | Change From Baseline in Mean Intraocular Pressure (IOP) in the Study Eye to Month 12 | Baseline (preoperation) | 21.0 mmHg | Standard Deviation 3.39 |
| XEN® Gel Stent With Cataract Surgery | Change From Baseline in Mean Intraocular Pressure (IOP) in the Study Eye to Month 12 | Change from Baseline to Month 12 | -6.4 mmHg | Standard Deviation 4.96 |
Primary
Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 12
The use of topical IOP-lowering medications was recorded at the preoperative screening visit and at the 12 Month postoperative visit. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.
Time frame: Baseline (≤ 90 days Preoperative) to Month 12 (Postoperative)
Population: mITT Population included all eligible eyes that met IOP and IOP-lowering medication inclusion criteria and received the XEN45 implant. Number analyzed is the number of eyes with data at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| XEN® Gel Stent | Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 12 | Baseline (preoperation) | 2.7 medications | Standard Deviation 0.93 |
| XEN® Gel Stent | Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 12 | Change from Baseline to Month 12 | -1.8 medications | Standard Deviation 1.31 |
| XEN® Gel Stent With Cataract Surgery | Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 12 | Baseline (preoperation) | 2.5 medications | Standard Deviation 0.88 |
| XEN® Gel Stent With Cataract Surgery | Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 12 | Change from Baseline to Month 12 | -1.6 medications | Standard Deviation 1.17 |
Primary
Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 24
The use of topical IOP-lowering medications was recorded at the preoperative screening visit and at the 24 Month postoperative visit. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.
Time frame: Baseline (≤ 90 days Preoperative) to Month 24 (Postoperative)
Population: mITT Population included all eligible eyes that met IOP and IOP-lowering medication inclusion criteria and received the XEN45 implant. Number analyzed is the number of eyes with data at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| XEN® Gel Stent | Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 24 | Baseline (preoperation) | 2.7 medications | Standard Deviation 0.93 |
| XEN® Gel Stent | Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 24 | Change from Baseline to Month 24 | -1.5 medications | Standard Deviation 1.54 |
| XEN® Gel Stent With Cataract Surgery | Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 24 | Baseline (preoperation) | 2.5 medications | Standard Deviation 0.88 |
| XEN® Gel Stent With Cataract Surgery | Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 24 | Change from Baseline to Month 24 | -1.5 medications | Standard Deviation 1.22 |
Primary
Mean Change From Baseline in IOP in the Study Eyes to Month 24
IOP is a measurement of the fluid pressure inside the eye. Two IOP measurements were taken, followed by a third if the first 2 differed by 3 mmHg or more. The measurements were averaged. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.
Time frame: Baseline (≤ 90 days Preoperative) to Month 24 (Postoperative)
Population: mITT Population included all eligible eyes that met IOP and IOP-lowering medication inclusion criteria and received the XEN45 implant. Number analyzed is the number of eyes with data at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| XEN® Gel Stent | Mean Change From Baseline in IOP in the Study Eyes to Month 24 | Baseline (preoperation) | 21.7 mmHg | Standard Deviation 3.76 |
| XEN® Gel Stent | Mean Change From Baseline in IOP in the Study Eyes to Month 24 | Change from Baseline to Month 24 | -6.4 mmHg | Standard Deviation 5.18 |
| XEN® Gel Stent With Cataract Surgery | Mean Change From Baseline in IOP in the Study Eyes to Month 24 | Baseline (preoperation) | 21.0 mmHg | Standard Deviation 3.39 |
| XEN® Gel Stent With Cataract Surgery | Mean Change From Baseline in IOP in the Study Eyes to Month 24 | Change from Baseline to Month 24 | -5.9 mmHg | Standard Deviation 4.6 |