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A retrospective, non-interventional, observational, multi-center, chart review study to be conducted in participants who underwent placement of the XEN 45 Gel Stent as a standalone procedure or in combination with phacoemulsification from 1 January 2014 to 1 October 2015.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Implant | Chart review was conducted in participants with open angle glaucoma who underwent placement of the implant XEN 45 Gel Stent as a standalone procedure from 1 January 2014 to 1 October 2015. For each eye selected, all retrospective data available from baseline (day when decision was made to implant XEN 45 Gel Stent) until the last visit was extracted from existing medical records. |
| |
| Implant + Phaco | Chart review was conducted in participants with open angle glaucoma who underwent placement of the implant XEN 45 Gel Stent in combination with phacoemulsification (Phaco) from 1 January 2014 to 1 October 2015. For each eye selected, all retrospective data available from baseline (day when decision was made to implant XEN 45 Gel Stent) until the last visit was extracted from existing medical records. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XEN Group | Device | Chart review was conducted in participants with open angle glaucoma who underwent placement of the implant XEN 45 Gel Stent as a standalone procedure from 1 January 2014 to 1 October 2015. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Intraocular Pressure (IOP) to 36 Months After Implantation | IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement. | Baseline (Day decision was made to implant XEN 45 Gel Stent) to 36 months after implantation |
| Change From Baseline in the Number of Topical IOP-lowering Medications 36 Months After Implantation | IOP-lowering medications included Beta blocking agents, Carbonic anhydrase inhibitors, Parasympathomimetics, Prostaglandin analogues, and Sympathomimetics in glaucoma therapy. | Baseline (Day decision was made to implant XEN 45 Gel Stent) to 36 months after implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean IOP to 48 Months After Implantation | IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement. | Baseline (Day decision was made to implant XEN 45 Gel Stent) to 48 months after implantation |
| Change From Baseline in the Number of Topical IOP-lowering Medications 48 Months After Implantation |
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Inclusion Criteria:
Exclusion Criteria
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Participant eyes that underwent XEN 45 Gel Stent implantation from 1 January 2014 until 1 October 2015.
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| Name | Affiliation | Role |
|---|---|---|
| Mini Balaram, MD | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trials Registry Team | Irvine | California | 92622 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Implant | Chart review was conducted in participants with open angle glaucoma who underwent placement of the implant XEN 45 Gel Stent as a standalone procedure from 1 January 2014 to 1 October 2015. For each eye selected, all retrospective data available from baseline (day when decision was made to implant XEN 45 Gel Stent) until the last visit was extracted from existing medical records. |
| FG001 | Implant + Phaco | Chart review was conducted in participants with open angle glaucoma who underwent placement of the implant XEN 45 Gel Stent in combination with phacoemulsification (Phaco) from 1 January 2014 to 1 October 2015. For each eye selected, all retrospective data available from baseline (day when decision was made to implant XEN 45 Gel Stent) until the last visit was extracted from existing medical records. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Effectiveness Population consisted of all eligible participant eyes. In instances when a participant contributed both eyes in study eye that received XEN 45 Gel implant first was selected (primary eye).
| ID | Title | Description |
|---|---|---|
| BG000 | Implant | Chart review was conducted in participants with open angle glaucoma who underwent placement of the implant XEN 45 Gel Stent as a standalone procedure from 1 January 2014 to 1 October 2015. For each eye selected, all retrospective data available from baseline (day when decision was made to implant XEN 45 Gel Stent) until the last visit was extracted from existing medical records. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Change From Baseline in Mean Intraocular Pressure (IOP) to 36 Months After Implantation | IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement. | Participants from effectiveness population, all eligible participant eyes with data available at Baseline.In instances when a participant contributed both eyes, eye that received XEN45Gel implant first was selected(primary eye).Analysis included 1 eye for each participant.Number analyzed:number of participants and eyes analyzed at given timepoint. | Posted | Mean | Standard Deviation | mm Hg | Baseline (Day decision was made to implant XEN 45 Gel Stent) to 36 months after implantation | eyes | eyes |
|
Baseline (Day decision was made to implant XEN 45 Gel Stent) to approximately 51 Months
Only AESIs were collected for this study.
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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 | Implant | Chart review was conducted in participants with open angle glaucoma who underwent placement of the implant XEN 45 Gel Stent as a standalone procedure from 1 January 2014 to 1 October 2015. For each eye selected, all retrospective data available from baseline (day when decision was made to implant XEN 45 Gel Stent) until the last visit was extracted from existing medical records. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleb leak | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area, Head | Allergan | 714-246-4500 | clinicaltrials@allergan.com |
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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 | Sep 17, 2018 | Oct 25, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 18, 2019 | Oct 25, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D018918 | Phacoemulsification |
| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Phacoemulsification | Procedure | Chart review was conducted in participants with open angle glaucoma who underwent placement of the implant XEN 45 Gel Stent in combination with phacoemulsification (Phaco) from 1 January 2014 to 1 October 2015. |
|
IOP-lowering medications included Beta blocking agents, Carbonic anhydrase inhibitors, Parasympathomimetics, Prostaglandin analogues, and Sympathomimetics in glaucoma therapy. |
| Baseline (Day decision was made to implant XEN 45 Gel Stent) to 48 months after implantation |
| Percentage of Eyes Achieving Qualified Success at Month 36 | Qualified success of implantation of the XEN 45 Gel Stent is defined as ≥20% reduction in IOP from medicated baseline with no SSI for glaucoma and no clinical hypotony while staying on the same number or fewer topical IOP-lowering medications than at Baseline. | Baseline (Day decision was made to implant XEN 45 Gel Stent), Month 36 |
| Percentage of Eyes Achieving Qualified Success at Month 48 | Qualified success of implantation of the XEN 45 Gel Stent is defined as ≥20% reduction in IOP from medicated baseline with no SSI for glaucoma and no clinical hypotony while staying on the same number or fewer topical IOP-lowering medications than at Baseline. | Baseline (Day decision was made to implant XEN 45 Gel Stent), Month 48 |
| Percentage of Eyes Achieving Complete Success at Month 36 | Complete success of implantation of the XEN 45 Gel Stent is defined as ≥20% reduction in IOP from Baseline with no SSI for glaucoma and no clinical hypotony while taking no topical IOP-lowering medications. | Baseline (Day decision was made to implant XEN 45 Gel Stent), Month 36 |
| Percentage of Eyes Achieving Complete Success at Month 48 | Complete success of implantation of the XEN 45 Gel Stent is defined as ≥20% reduction in IOP from Baseline with no SSI for glaucoma and no clinical hypotony while taking no topical IOP-lowering medications. | Baseline (Day decision was made to implant XEN 45 Gel Stent), Month 48 |
| Percentage of Eyes With Adverse Events of Special Interest (AESIs) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a drug whether or not it is considered related to drug. AESI include: Glaucoma, defined as damage to optic nerve with progressive vision loss, Intraocular hypertension, defined as IOP without meeting criteria for glaucoma, Hypotony, defined as low IOP ≤5 mmHg, Cataract or lens opacities, Ocular bleeding or hemorrhage, Retinal detachment, tear or hole, Vitreous detachment, Infection vs. Non-infection related Ocular inflammation, Significant vitreous loss, Mechanical failure of device and implant misplacement, Implant dislocation. Data of AESIs are presented based on eyes for this outcome measure. | Baseline (Day decision was made to implant XEN 45 Gel Stent) to approximately 51 Months |
| BG001 | Implant + Phaco | Chart review was conducted in participants with open angle glaucoma who underwent placement of the implant XEN 45 Gel Stent in combination with phacoemulsification (Phaco) from 1 January 2014 to 1 October 2015. For each eye selected, all retrospective data available from baseline (day when decision was made to implant XEN 45 Gel Stent) until the last visit was extracted from existing medical records. |
| BG002 | Total | Total of all reporting groups |
| eyes |
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| years |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants | Participants |
|
| OG001 | Implant + Phaco | Chart review was conducted in participants with open angle glaucoma who underwent placement of the implant XEN 45 Gel Stent in combination with phacoemulsification (Phaco) from 1 January 2014 to 1 October 2015. For each eye selected, all retrospective data available from baseline (day when decision was made to implant XEN 45 Gel Stent) until the last visit was extracted from existing medical records. |
|
|
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| Primary | Change From Baseline in the Number of Topical IOP-lowering Medications 36 Months After Implantation | IOP-lowering medications included Beta blocking agents, Carbonic anhydrase inhibitors, Parasympathomimetics, Prostaglandin analogues, and Sympathomimetics in glaucoma therapy. | Participants from effectiveness population, all eligible participant eyes with data available at Baseline.In instances when a participant contributed both eyes, eye that received XEN45Gel implant first was selected(primary eye).Analysis included 1 eye for each participant.Number analyzed:number of participants and eyes analyzed at given timepoint. | Posted | Mean | Standard Deviation | medications | Baseline (Day decision was made to implant XEN 45 Gel Stent) to 36 months after implantation | eyes | eyes |
|
|
|
|
| Secondary | Change From Baseline in Mean IOP to 48 Months After Implantation | IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement. | Participants from effectiveness population, all eligible participant eyes with data available at Baseline.In instances when a participant contributed both eyes, eye that received XEN45Gel implant first was selected(primary eye).Analysis included 1 eye for each participant.Number analyzed:number of participants and eyes analyzed at given timepoint. | Posted | Mean | Standard Deviation | mm Hg | Baseline (Day decision was made to implant XEN 45 Gel Stent) to 48 months after implantation | eyes | eyes |
|
|
|
|
| Secondary | Change From Baseline in the Number of Topical IOP-lowering Medications 48 Months After Implantation | IOP-lowering medications included Beta blocking agents, Carbonic anhydrase inhibitors, Parasympathomimetics, Prostaglandin analogues, and Sympathomimetics in glaucoma therapy. | Participants from effectiveness population, all eligible participant eyes with data available at Baseline.In instances when a participant contributed both eyes, eye that received XEN45Gel implant first was selected(primary eye).Analysis included 1 eye for each participant.Number analyzed:number of participants and eyes analyzed at given timepoint. | Posted | Mean | Standard Deviation | medications | Baseline (Day decision was made to implant XEN 45 Gel Stent) to 48 months after implantation | eyes | eyes |
|
|
|
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| Secondary | Percentage of Eyes Achieving Qualified Success at Month 36 | Qualified success of implantation of the XEN 45 Gel Stent is defined as ≥20% reduction in IOP from medicated baseline with no SSI for glaucoma and no clinical hypotony while staying on the same number or fewer topical IOP-lowering medications than at Baseline. | Participants from effectiveness population, consisting of all eligible participants eyes, with data available for analyses. In instances when a participant contributed both eyes in the study, the eye that received XEN 45 Gel implant first was selected (primary eye). Analysis included one eye for each participant. | Posted | Number | percentage of eyes | Baseline (Day decision was made to implant XEN 45 Gel Stent), Month 36 | eyes | eyes |
|
|
|
| Secondary | Percentage of Eyes Achieving Qualified Success at Month 48 | Qualified success of implantation of the XEN 45 Gel Stent is defined as ≥20% reduction in IOP from medicated baseline with no SSI for glaucoma and no clinical hypotony while staying on the same number or fewer topical IOP-lowering medications than at Baseline. | Participants from effectiveness population, consisting of all eligible participants eyes, with data available for analyses. In instances when a participant contributed both eyes in the study, the eye that received XEN 45 Gel implant first was selected (primary eye). Analysis included one eye for each participant. | Posted | Number | percentage of eyes | Baseline (Day decision was made to implant XEN 45 Gel Stent), Month 48 | eyes | eyes |
|
|
|
| Secondary | Percentage of Eyes Achieving Complete Success at Month 36 | Complete success of implantation of the XEN 45 Gel Stent is defined as ≥20% reduction in IOP from Baseline with no SSI for glaucoma and no clinical hypotony while taking no topical IOP-lowering medications. | Participants from effectiveness population, consisting of all eligible participants eyes, with data available for analyses. In instances when a participant contributed both eyes in the study, the eye that received XEN 45 Gel implant first was selected (primary eye). Analysis included one eye for each participant. | Posted | Number | percentage of eyes | Baseline (Day decision was made to implant XEN 45 Gel Stent), Month 36 | eyes | eyes |
|
|
|
| Secondary | Percentage of Eyes Achieving Complete Success at Month 48 | Complete success of implantation of the XEN 45 Gel Stent is defined as ≥20% reduction in IOP from Baseline with no SSI for glaucoma and no clinical hypotony while taking no topical IOP-lowering medications. | Participants from effectiveness population, consisting of all eligible participants eyes, with data available for analyses. In instances when a participant contributed both eyes in the study, the eye that received XEN 45 Gel implant first was selected (primary eye). Analysis included one eye for each participant. | Posted | Number | percentage of eyes | Baseline (Day decision was made to implant XEN 45 Gel Stent), Month 48 | eyes | eyes |
|
|
|
| Secondary | Percentage of Eyes With Adverse Events of Special Interest (AESIs) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a drug whether or not it is considered related to drug. AESI include: Glaucoma, defined as damage to optic nerve with progressive vision loss, Intraocular hypertension, defined as IOP without meeting criteria for glaucoma, Hypotony, defined as low IOP ≤5 mmHg, Cataract or lens opacities, Ocular bleeding or hemorrhage, Retinal detachment, tear or hole, Vitreous detachment, Infection vs. Non-infection related Ocular inflammation, Significant vitreous loss, Mechanical failure of device and implant misplacement, Implant dislocation. Data of AESIs are presented based on eyes for this outcome measure. | Safety Population consisted of all eligible participant eyes in the study population. For participants implanted bilaterally, both eyes were included for analysis if both met the eligibility criteria. | Posted | Number | percentage of eyes | Baseline (Day decision was made to implant XEN 45 Gel Stent) to approximately 51 Months | eyes | eyes |
|
|
|
| 0 |
| 98 |
| 2 |
| 98 |
| 0 |
| 98 |
| EG001 | Implant + Phaco | Chart review was conducted in participants with open angle glaucoma who underwent placement of the implant XEN 45 Gel Stent in combination with phacoemulsification (Phaco) from 1 January 2014 to 1 October 2015. For each eye selected, all retrospective data available from baseline (day when decision was made to implant XEN 45 Gel Stent) until the last visit was extracted from existing medical records. | 0 | 76 | 0 | 76 | 0 | 76 |
| Endophthalmitis | Eye disorders | Systematic Assessment |
|
| Persistent Hypotony | Eye disorders | Systematic Assessment |
|
| Clinical Hypotony | Eye disorders | Systematic Assessment |
|
| Anterior chamber defects | Eye disorders | Systematic Assessment |
|
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.
| D059708 | Ultrasonic Surgical Procedures |
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| Change from Baseline to Month 36 |
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| Other |
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| Change from Baseline to Month 48 |
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| Other |
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| Change from Baseline to Month 48 |
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| Other |