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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XEN® Gel Stent | Other | The XEN®45 Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure. |
|
| XEN® Gel Stent with Cataract Surgery | Other | The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XEN® Gel Stent | Device | The XEN® Gel Stent (XEN45 implant) was placed in the study eye. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (≤ 90 days Preoperative) to Month 12 (Postoperative) |
| 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. | Baseline (≤ 90 days Preoperative) to Month 12 (Postoperative) |
| 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. | Baseline (≤ 90 days Preoperative) to Month 24 (Postoperative) |
| 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. | Baseline (≤ 90 days Preoperative) to Month 24 (Postoperative) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vanessa Vera, MD | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Graz | Graz | 8036 | Austria | |||
| University Augenklinik Salzburg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30758653 | Derived | Reitsamer H, Sng C, Vera V, Lenzhofer M, Barton K, Stalmans I; Apex Study Group. Two-year results of a multicenter study of the ab interno gelatin implant in medically uncontrolled primary open-angle glaucoma. Graefes Arch Clin Exp Ophthalmol. 2019 May;257(5):983-996. doi: 10.1007/s00417-019-04251-z. Epub 2019 Feb 13. | |
| 29267575 |
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| ID | Title | Description |
|---|---|---|
| FG000 | XEN® Gel Stent | The XEN® Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure. |
| FG001 | XEN® Gel Stent With Cataract Surgery | The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Cataract Surgery | Procedure | Participants diagnosed with a cataract elected to have cataract surgery. |
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| Salzburg |
| 5020 |
| Austria |
| Vienna University | Vienna | 1090 | Austria |
| University Hospitals Leuven | Leuven | B-3000 | Belgium |
| University Eye Clinic Bochum-Langendreer | Bochum | 44892 | Germany |
| Klinik für Augenheilkunde | Frankfurt | D-60590 | Germany |
| Klinik fur Augenheilkunde | Neubrandenburg | 17036 | Germany |
| University of Pisa | Pisa | 56124 | Italy |
| Clinica Oculistica, Universita' di Torino | Torino | 10100 | Italy |
| Integrated University Hospital of Verona | Verona | 37126 | Italy |
| Ophthalmology Department of the Military Health Service Institute | Warsaw | 04-141 | Poland |
| Hospital Meixeiro Servicio de Ofthalmologia | Vigo | Pontevedra | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Principe de Asturias | Madrid | Spain |
| University of Geneva | Geneva | 1211 | Switzerland |
| Maidstone Hospital Eye, Ear and Mouth Unit | Maidstone | Kent | ME16 9QQ | United Kingdom |
| Birmingham Midland Eye Theaters | Birmingham | West Midlands | B18 7QH | United Kingdom |
| Moorfields Eye Hospital | London | EC1V2PD | United Kingdom |
| St. Thomas Hospital | London | SE17EH | United Kingdom |
| Pinderfields Hospital | Wakefield | WF14DG | United Kingdom |
| Unidad Oftalmologica de Caracas | Caracas | Venezuela |
| 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. |
| COMPLETED |
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| NOT COMPLETED |
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Modified Intent-to-Treat (mITT) Population included all eligible eyes that met IOP and IOP-lowering medication inclusion criteria and received the XEN45 implant.
| ID | Title | Description |
|---|---|---|
| BG000 | XEN® Gel Stent | The XEN® Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure. |
| BG001 | XEN® Gel Stent With Cataract Surgery | The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Eyes |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years | Participants |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants | Participants |
|
| 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 | 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. | 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. | Posted | Mean | Standard Deviation | mmHg | Baseline (≤ 90 days Preoperative) to Month 12 (Postoperative) | eyes | eyes |
|
|
| |||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | medications | Baseline (≤ 90 days Preoperative) to Month 12 (Postoperative) | eyes | eyes |
|
| ||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | mmHg | Baseline (≤ 90 days Preoperative) to Month 24 (Postoperative) | eyes | eyes |
|
| ||||||||||||||||||||||||
| 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. | 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. | Posted | Mean | Standard Deviation | medications | Baseline (≤ 90 days Preoperative) to Month 24 (Postoperative) | eyes | eyes |
|
|
Up to 26 Months
The number at risk for Serious Adverse Events and Other Adverse Events (AEs) is based on the number of eyes included in the Safety Population. In this study all AEs were collected at eye level since this is an ophthalmic device. If a participant had both eyes in the study, AEs from each eye were collected separately. Systemic AEs (not local to the participating eyes) were collected twice but to avoid duplication were counted toward the right eyes only.
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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® Gel Stent | The XEN® Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure. | 2 | 112 | 12 | 120 | 14 | 120 |
| EG001 | XEN® Gel Stent With Cataract Surgery | The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract. | 2 | 87 | 6 | 98 | 8 | 98 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Heart attack | Cardiac disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Cataract aggravated | Eye disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Retinal disorder | Eye disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Implant site dehiscence | General disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Decompensated cirrhosis | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
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| Endophthalmitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
| |
| Broken hip | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Intraocular pressure high | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Intraocular pressure high - fellow eye | Investigations | MedDRA 20.0 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
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| Kidney tumor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
| |
| Oral cancer stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
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| Stomach cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Systematic Assessment |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
| |
| Trabeculectomy | Surgical and medical procedures | MedDRA 20.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyphema | Injury, poisoning and procedural complications | MedDRA 20.0 | Systematic Assessment |
| |
| Trabeculectomy | Surgical and medical procedures | MedDRA 20.0 | Systematic Assessment |
| |
| YAG (yttrium-aluminum-garnet) laser surgery | Surgical and medical procedures | MedDRA 20.0 | Systematic Assessment |
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A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area, Head | Allergan | 714-246-4500 | clinicaltrials@allergan.com |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| ID | Term |
|---|---|
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Male |
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| Black or African American |
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| Asian |
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| Change from Baseline to Month 12 |
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| eyes |
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| eyes |
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| eyes |
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