Trial Outcomes & Findings for Chart Review of XEN 45 Gel Stent: Long Term Performance and Safety Assessment (XEN LT) (NCT NCT03868254)

Results Overview

IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement.

Recruitment status

COMPLETED

Target enrollment

174 participants

Primary outcome timeframe

Baseline (Day decision was made to implant XEN 45 Gel Stent) to 36 months after implantation

Results posted on

2020-11-17

Participant Flow

Unit of analysis: Eyes

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	98 116	76 96
Overall Study COMPLETED	98 116	76 96
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Chart Review of XEN 45 Gel Stent: Long Term Performance and Safety Assessment (XEN LT)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Implant n=98 eyes 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 n=76 eyes 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.	Total n=174 eyes Total of all reporting groups
Age, Continuous	69.40 years STANDARD_DEVIATION 12.193 • n=5 Participants	75.95 years STANDARD_DEVIATION 7.107 • n=7 Participants	72.26 years STANDARD_DEVIATION 10.764 • n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	39 Participants n=7 Participants	91 Participants n=5 Participants
Sex: Female, Male Male	46 Participants n=5 Participants	37 Participants n=7 Participants	83 Participants n=5 Participants
Race/Ethnicity, Customized White, Caucasian	91 Participants n=5 Participants	75 Participants n=7 Participants	166 Participants n=5 Participants
Race/Ethnicity, Customized Latin American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day decision was made to implant XEN 45 Gel Stent) to 36 months after implantation

Population: 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.

IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement.

Outcome measures

Outcome measures
Measure	Implant n=90 eyes 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 n=73 eyes 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.
Change From Baseline in Mean Intraocular Pressure (IOP) to 36 Months After Implantation Baseline	21.03 mm Hg Standard Deviation 4.638	20.21 mm Hg Standard Deviation 5.640
Change From Baseline in Mean Intraocular Pressure (IOP) to 36 Months After Implantation Change from Baseline to Month 36	-6.42 mm Hg Standard Deviation 5.655	-6.73 mm Hg Standard Deviation 7.620

PRIMARY outcome

Timeframe: Baseline (Day decision was made to implant XEN 45 Gel Stent) to 36 months after implantation

Population: 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.

IOP-lowering medications included Beta blocking agents, Carbonic anhydrase inhibitors, Parasympathomimetics, Prostaglandin analogues, and Sympathomimetics in glaucoma therapy.

Outcome measures

Outcome measures
Measure	Implant n=90 eyes 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 n=73 eyes 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.
Change From Baseline in the Number of Topical IOP-lowering Medications 36 Months After Implantation Baseline	2.6 medications Standard Deviation 0.98	2.4 medications Standard Deviation 1.02
Change From Baseline in the Number of Topical IOP-lowering Medications 36 Months After Implantation Change from Baseline to Month 36	-1.6 medications Standard Deviation 1.49	-1.2 medications Standard Deviation 1.52

SECONDARY outcome

Timeframe: Baseline (Day decision was made to implant XEN 45 Gel Stent) to 48 months after implantation

Population: 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.

IOP is a measurement of the fluid pressure inside the eye. A negative change from Baseline indicates an improvement.

Outcome measures

Outcome measures
Measure	Implant n=90 eyes 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 n=73 eyes 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.
Change From Baseline in Mean IOP to 48 Months After Implantation Baseline	21.03 mm Hg Standard Deviation 4.638	20.21 mm Hg Standard Deviation 5.640
Change From Baseline in Mean IOP to 48 Months After Implantation Change from Baseline to Month 48	-5.46 mm Hg Standard Deviation 4.998	-5.27 mm Hg Standard Deviation 5.298

SECONDARY outcome

Timeframe: Baseline (Day decision was made to implant XEN 45 Gel Stent) to 48 months after implantation

Population: 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.

IOP-lowering medications included Beta blocking agents, Carbonic anhydrase inhibitors, Parasympathomimetics, Prostaglandin analogues, and Sympathomimetics in glaucoma therapy.

Outcome measures

Outcome measures
Measure	Implant n=90 eyes 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 n=73 eyes 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.
Change From Baseline in the Number of Topical IOP-lowering Medications 48 Months After Implantation Baseline	2.6 medications Standard Deviation 0.98	2.4 medications Standard Deviation 1.02
Change From Baseline in the Number of Topical IOP-lowering Medications 48 Months After Implantation Change from Baseline to Month 48	-1.1 medications Standard Deviation 1.08	-0.8 medications Standard Deviation 1.42

SECONDARY outcome

Timeframe: Baseline (Day decision was made to implant XEN 45 Gel Stent), Month 36

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Implant n=46 eyes 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 n=30 eyes 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.
Percentage of Eyes Achieving Qualified Success at Month 36	23.9 percentage of eyes	40.0 percentage of eyes

SECONDARY outcome

Timeframe: Baseline (Day decision was made to implant XEN 45 Gel Stent), Month 48

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Implant n=12 eyes 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 n=15 eyes 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.
Percentage of Eyes Achieving Qualified Success at Month 48	25.0 percentage of eyes	33.3 percentage of eyes

SECONDARY outcome

Timeframe: Baseline (Day decision was made to implant XEN 45 Gel Stent), Month 36

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Implant n=46 eyes 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 n=30 eyes 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.
Percentage of Eyes Achieving Complete Success at Month 36	45.7 percentage of eyes	20.0 percentage of eyes

SECONDARY outcome

Timeframe: Baseline (Day decision was made to implant XEN 45 Gel Stent), Month 48

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Implant n=12 eyes 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 n=15 eyes 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.
Percentage of Eyes Achieving Complete Success at Month 48	33.3 percentage of eyes	20.0 percentage of eyes

SECONDARY outcome

Timeframe: Baseline (Day decision was made to implant XEN 45 Gel Stent) to approximately 51 Months

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Implant n=116 eyes 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 n=96 eyes 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.
Percentage of Eyes With Adverse Events of Special Interest (AESIs)	18.1 percentage of eyes	10.4 percentage of eyes

Adverse Events

Implant

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Implant + Phaco

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Implant n=98 participants at risk 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 n=76 participants at risk 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.
Eye disorders Bleb leak	1.0% 1/98 • Baseline (Day decision was made to implant XEN 45 Gel Stent) to approximately 51 Months Only AESIs were collected for this study.	0.00% 0/76 • Baseline (Day decision was made to implant XEN 45 Gel Stent) to approximately 51 Months Only AESIs were collected for this study.
Eye disorders Endophthalmitis	1.0% 1/98 • Baseline (Day decision was made to implant XEN 45 Gel Stent) to approximately 51 Months Only AESIs were collected for this study.	0.00% 0/76 • Baseline (Day decision was made to implant XEN 45 Gel Stent) to approximately 51 Months Only AESIs were collected for this study.
Eye disorders Persistent Hypotony	1.0% 1/98 • Baseline (Day decision was made to implant XEN 45 Gel Stent) to approximately 51 Months Only AESIs were collected for this study.	0.00% 0/76 • Baseline (Day decision was made to implant XEN 45 Gel Stent) to approximately 51 Months Only AESIs were collected for this study.
Eye disorders Clinical Hypotony	1.0% 1/98 • Baseline (Day decision was made to implant XEN 45 Gel Stent) to approximately 51 Months Only AESIs were collected for this study.	0.00% 0/76 • Baseline (Day decision was made to implant XEN 45 Gel Stent) to approximately 51 Months Only AESIs were collected for this study.
Eye disorders Anterior chamber defects	1.0% 1/98 • Baseline (Day decision was made to implant XEN 45 Gel Stent) to approximately 51 Months Only AESIs were collected for this study.	0.00% 0/76 • Baseline (Day decision was made to implant XEN 45 Gel Stent) to approximately 51 Months Only AESIs were collected for this study.

Other adverse events

Adverse event data not reported

Additional Information

Therapeutic Area, Head

Allergan

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER