Glaucoma, Glaucoma, Open Angle
Conditions
Keywords
Glaucoma Implant, Trabeculectomy, POAG, Primary Open Angle Glaucoma, Pseudoexfoliation Glaucoma, Pigmentary Glaucoma
Brief summary
To establish the safety and performance of the AqueSys XEN 45 Glaucoma Implant in eyes with refractory glaucoma.
Detailed description
A prospective, multi-center, single arm, open-label clinical trial to evaluate the safety and IOP lowering performance of the AqueSys XEN 45 Glaucoma Implant in refractory glaucoma patients.
Interventions
DEVICEAqueSys XEN 45 Glaucoma Implant
Placement of the AqueSys XEN 45 Glaucoma Implant in the study eye
Sponsors
Allergan
AqueSys, 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
* Diagnosis of Refractory Glaucoma * Maximally-tolerated medicated IOP at two preoperative visits of ≥20 mmHg and ≤35 mmHg * Visual field mean deviation score of -3 dB or worse * Shaffer Angle Grade ≥ 3 * Area of free, healthy and mobile conjunctiva in the targeted quadrant
Exclusion criteria
* Active Neovascular Glaucoma * Previous glaucoma shunt/valve in the targeted quadrant * History of corneal surgery, opacities or disease/pathology * Anticipated need for ocular surgery * Non-study eye with BCVA of 20/200 or worse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects Achieving a 20% or Greater Reduction in IOP From Baseline on the Same or Less Number of Medications | 12 Months | Proportion of subjects achieving a 20% or greater reduction in IOP from baseline on the same or less number of medications. Subjects who underwent a glaucoma-related secondary surgical intervention prior to the 12-month visit were considered failures in this analysis. |
| Mean Change in IOP From Baseline | 12 Months | Mean change in IOP from baseline was calculated for subjects who completed the 12-month visit and the worst within-eye IOP was used for subjects who underwent a glaucoma-related secondary surgical intervention. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| XEN 45 Gel Stent Placement of the XEN 45 Gel Stent in the study eye | 65 |
| Total | 65 |
Baseline characteristics
| Characteristic | XEN 45 Gel Stent |
|---|---|
| Age, Continuous | 70 years STANDARD_DEVIATION 12.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 52 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Glaucoma Type Mixed Mechanism Glaucoma | 1 Participants |
| Glaucoma Type Pigmentary Glaucoma | 1 Participants |
| Glaucoma Type Primary Open Angle Glaucoma | 57 Participants |
| Glaucoma Type Pseudoexfolative Glaucoma | 6 Participants |
| Previous Cataract Surgery | 45 Participants |
| Prior Glaucoma Procedure No prior glaucoma procedure | 10 Participants |
| Prior Glaucoma Procedure Prior incisional glaucoma procedure | 41 Participants |
| Prior Glaucoma Procedure Prior laser trabeculoplasty | 14 Participants |
| Region of Enrollment United States | 65 participants |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 65 |
| other Total, other adverse events | 45 / 65 |
| serious Total, serious adverse events | 9 / 65 |
Outcome results
Primary
Mean Change in IOP From Baseline
Mean change in IOP from baseline was calculated for subjects who completed the 12-month visit and the worst within-eye IOP was used for subjects who underwent a glaucoma-related secondary surgical intervention.
Time frame: 12 Months
Population: All subjects who completed the 12-month visit or underwent a glaucoma-related secondary surgical procedure prior to the 12-month visit were evaluated in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| XEN 45 Gel Stent | Mean Change in IOP From Baseline | 6.2 mmHg | Standard Deviation 9.1 |
Primary
Proportion of Subjects Achieving a 20% or Greater Reduction in IOP From Baseline on the Same or Less Number of Medications
Proportion of subjects achieving a 20% or greater reduction in IOP from baseline on the same or less number of medications. Subjects who underwent a glaucoma-related secondary surgical intervention prior to the 12-month visit were considered failures in this analysis.
Time frame: 12 Months
Population: All subjects who completed the 12-month visit or underwent a glaucoma-related secondary surgical procedure prior to the 12-month visit were evaluated in this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| XEN 45 Gel Stent | Proportion of Subjects Achieving a 20% or Greater Reduction in IOP From Baseline on the Same or Less Number of Medications | 46 Participants |