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This study will evaluate the safety and IOP-lowering effectiveness of XEN in patients with Angle Closure Glaucoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XEN45 Glaucoma Treatment System (hereafter referred to as XEN) | Experimental | XEN45 unilaterally implanted in the study eye |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XEN45 | Device | XEN45 unilaterally implanted in the study eye |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 12 |
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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
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| Name | Affiliation | Role |
|---|---|---|
| ALLERGAN INC. | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marsden Eye Specialists Parramatta /ID# 232761 | Parramatta | New South Wales | 2150 | Australia | ||
| Melbourne Eye Specialists /ID# 232767 |
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
For details on when studies are available for sharing, please refer to the link below
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: XEN45 Glaucoma Treatment System (Hereafter Referred to as XEN) | XEN45 unilaterally implanted in the study eye |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 4, 2017 | Jan 31, 2023 |
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| Fitzroy |
| Victoria |
| VIC3065 |
| Australia |
| Eye Surgery Associates P/L ATF Eye Surgery Associates Unit Trust /ID# 232765 | Vermont South | Victoria | 3133 | Australia |
| Institut de loeil des Laurentides /ID# 232780 | Boisbriand | Quebec | J7H 0E8 | Canada |
| Ophthalmology Clinic Bellevue /ID# 232782 | Montreal | Quebec | H1V 1G5 | Canada |
| Prism Eye Institute /ID# 232917 | Mississauga | L5L 1W8 | Canada |
| Nuh Medical Centre /ID# 232905 | Singapore | 119082 | Singapore |
| Tan Tock Seng Hospital /ID# 233014 | Singapore | 308433 | Singapore |
| Seoul National University Hospital /ID# 233099 | Seoul | 03080 | South Korea |
| Buddhist Tzu Chi General Hospital /ID# 232664 | Hualien City | Hualien | 97002 | Taiwan |
| Taipei Veterans General Hospital /ID# 232948 | Taipei City | Taipei | 11217 | Taiwan |
| Royal Surrey County Hospital /ID# 233028 | Guildford | England | GU2 7XX | United Kingdom |
| Manchester University NHS Foundation Trust /ID# 232808 | Manchester | Lancashire | M13 9WL | United Kingdom |
| Queen Victoria Hospital /ID# 232812 | East Grinstead | West Sussex | RH19 3DZ | United Kingdom |
| East Suffolk and North Essex NHS Foundation Trust /ID# 232804 | Colchester | CO4 5JL | United Kingdom |
| NHS Lothian /ID# 233052 | Edinburgh | EH3 9HE | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | XEN45 Glaucoma Treatment System (Hereafter Referred to as XEN) | XEN45 unilaterally implanted 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 | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | 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 | 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.) | Posted | Number | 95% Confidence Interval | percentage of participants | Month 12 |
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| 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. | Implanted population, defined as all subjects implanted with XEN45, with data at visit. | Posted | Mean | Standard Deviation | Number of medications in study eye | Month 12 |
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Up tp 12 months after the initiation of XEN45 Implant related procedures
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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 | Experimental: XEN45 Glaucoma Treatment System (Hereafter Referred to as XEN) | XEN45 unilaterally implanted in the study eye | 2 | 62 | 12 | 62 | 44 | 62 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
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| ANGLE CLOSURE GLAUCOMA | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| CONJUNCTIVAL EROSION | Eye disorders | MedDRA 24.1 | Systematic Assessment |
| |
| SUBCONJUNCTIVAL FIBROSIS | Eye disorders | MedDRA 24.1 | Systematic Assessment |
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| PNEUMONIA | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| SEPTIC SHOCK | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| FALL | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
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| SKIN LACERATION | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
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| SPINAL COMPRESSION FRACTURE | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| SUBDURAL HAEMATOMA | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
| |
| INTRAOCULAR PRESSURE INCREASED | Investigations | MedDRA 24.1 | Systematic Assessment |
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| HYPOVOLAEMIA | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
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| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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| DEVICE PHYSICAL PROPERTY ISSUE | Product Issues | MedDRA 24.1 | Systematic Assessment |
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| ACUTE KIDNEY INJURY | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
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| CALCULUS BLADDER | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
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| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
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| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
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| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
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| HYPOTENSION | Vascular disorders | MedDRA 24.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CHOROIDAL EFFUSION | Eye disorders | MedDRA 24.1 | Systematic Assessment |
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| CONJUNCTIVAL HAEMORRHAGE | Eye disorders | MedDRA 24.1 | Systematic Assessment |
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| CONJUNCTIVAL HYPERAEMIA | Eye disorders | MedDRA 24.1 | Systematic Assessment |
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| CONJUNCTIVAL OEDEMA | Eye disorders | MedDRA 24.1 | Systematic Assessment |
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| CORNEAL OEDEMA | Eye disorders | MedDRA 24.1 | Systematic Assessment |
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| DRY EYE | Eye disorders | MedDRA 24.1 | Systematic Assessment |
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| ERYTHEMA OF EYELID | Eye disorders | MedDRA 24.1 | Systematic Assessment |
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| EYE PAIN | Eye disorders | MedDRA 24.1 | Systematic Assessment |
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| EYELID OEDEMA | Eye disorders | MedDRA 24.1 | Systematic Assessment |
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| FOREIGN BODY SENSATION IN EYES | Eye disorders | MedDRA 24.1 | Systematic Assessment |
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| PUNCTATE KERATITIS | Eye disorders | MedDRA 24.1 | Systematic Assessment |
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| VISION BLURRED | Eye disorders | MedDRA 24.1 | Systematic Assessment |
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| VISUAL ACUITY REDUCED | Eye disorders | MedDRA 24.1 | Systematic Assessment |
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| HYPHAEMA | Injury, poisoning and procedural complications | MedDRA 24.1 | Systematic Assessment |
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| INTRAOCULAR PRESSURE INCREASED | Investigations | MedDRA 24.1 | Systematic Assessment |
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| DEVICE OCCLUSION | Product Issues | MedDRA 24.1 | Systematic Assessment |
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AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 14, 2022 | Jan 31, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Singapore |
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| Taiwan |
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| United Kingdom |
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| Australia |
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