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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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To establish the safety and performance of the AqueSys XEN 45 Glaucoma Implant in eyes with refractory glaucoma.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AqueSys XEN 45 Glaucoma Implant | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AqueSys XEN 45 Glaucoma Implant | Device | Placement of the AqueSys XEN 45 Glaucoma Implant in the study eye |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 Months |
| 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. | 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard A Lewis, M.D. | Grutzmacher, Lewis & Sierra Surgical Eye Specialists | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| George R. Reiss, MD PC | Glendale | Arizona | 85306 | United States | ||
| Vold Vision |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29267575 | Derived | Ozal SA, Kaplaner O, Basar BB, Guclu H, Ozal E. An innovation in glaucoma surgery: XEN45 gel stent implantation. Arq Bras Oftalmol. 2017 Nov-Dec;80(6):382-385. doi: 10.5935/0004-2749.20170093. |
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| ID | Title | Description |
|---|---|---|
| FG000 | XEN 45 Gel Stent | Placement of the XEN 45 Gel Stent in the study eye |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | XEN 45 Gel Stent | Placement of the XEN 45 Gel Stent in the study eye |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | 12 Months |
|
Ocular adverse events in the study are reported from the day of surgery (Day 0) through the 12-month visit
Ocular adverse events in the study eye are reported from the day of surgery through the 12-month visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | XEN 45 Gel Stent | Placement of the XEN 45 Gel Stent in the study eye | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Explant | Eye disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotony (IOP < 6 mmHg) | Eye disorders | Non-systematic Assessment | All IOP < 6 mmHg was recorded as an adverse event, regardless of whether there were any associated complications or sequelae related to the low pressure. No clinically-significant consequences were associated with these hypotony cases |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rupali Nangia | Allergan plc | 714-246-6020 | rupali.nangia@allergan.com |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005902 | Glaucoma, Open-Angle |
| D017889 | Exfoliation Syndrome |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D007499 | Iris Diseases |
| D014603 | Uveal Diseases |
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| Fayetteville |
| Arkansas |
| 72704 |
| United States |
| Montebello Eye Center | Montebello | California | 90640 | United States |
| San Diego Eye Care Center | Oceanside | California | 92056 | United States |
| Palo Alto Eye Group | Palo Alto | California | 94306 | United States |
| Eye Center of Northern Colorado | Fort Collins | Colorado | 80525 | United States |
| Stiles Eyecare Excellence & Glaucoma Institute | Overland Park | Kansas | 66213 | United States |
| Washington University in St. Louis, Department of Ophthalmology | St Louis | Missouri | 63110 | United States |
| New York Eye and Ear Infirmary | New York | New York | 10003 | United States |
| Glaucoma Associates of Texas | Dallas | Texas | 75231 | United States |
| R and R Eye Research, LLC | San Antonio | Texas | 78229 | United States |
| Spokane Eye Clinic | Spokane | Washington | 99204 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Glaucoma Type | Count of Participants | Participants |
|
| Previous Cataract Surgery | Count of Participants | Participants |
|
| Prior Glaucoma Procedure | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | mmHg | 12 Months |
|
|
|
| 65 |
| 9 |
| 65 |
| 45 |
| 65 |
| Secondary glaucoma procedure with explant | Eye disorders | Non-systematic Assessment |
|
| Secondary glaucoma procedure | Eye disorders | Non-systematic Assessment |
|
|
| IOP increase ≥ 10 mmHg from baseline | Eye disorders | Non-systematic Assessment |
|
| Needling procedure | Eye disorders | Non-systematic Assessment | The protocol required these procedures to be recorded as adverse events |
|
| Wound dehiscence/leak | Eye disorders | Non-systematic Assessment |
|
| Wound repair | Eye disorders | Non-systematic Assessment |
|
| Anterior chamber tap | Eye disorders | Non-systematic Assessment |
|
| Best-Corrected Visual Acuity Loss of ≥ 2 lines ≤ 30 days postop | Eye disorders | Non-systematic Assessment |
|
| Best-Corrected Visual Acuity loss of ≥ 2 lines > 30 days | Eye disorders | Non-systematic Assessment |
|
| Best-Corrected Visual Acuity loss of ≥ 2 lines at 12 Months | Eye disorders | Non-systematic Assessment |
|
The disclosure restriction on the PI is that the results of the multi-center trial must be published first, prior to any of the individual data being published