Trial Outcomes & Findings for Safety and Effectiveness of the XEN45 Glaucoma Treatment System in Patients With Angle Closure Glaucoma (NCT NCT03362931)
NCT ID: NCT03362931
Last Updated: 2023-05-17
Results Overview
IOP will be measured using a Goldmann applanation tonometer
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
65 participants
Primary outcome timeframe
Month 12
Results posted on
2023-05-17
Participant Flow
Participant milestones
| Measure |
Experimental: XEN45 Glaucoma Treatment System (Hereafter Referred to as XEN)
XEN45 unilaterally implanted in the study eye
|
|---|---|
|
Overall Study
STARTED
|
62
|
|
Overall Study
COMPLETED
|
59
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Experimental: XEN45 Glaucoma Treatment System (Hereafter Referred to as XEN)
XEN45 unilaterally implanted in the study eye
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Death
|
2
|
Baseline Characteristics
Safety and Effectiveness of the XEN45 Glaucoma Treatment System in Patients With Angle Closure Glaucoma
Baseline characteristics by cohort
| Measure |
XEN45 Glaucoma Treatment System (Hereafter Referred to as XEN)
n=62 Participants
XEN45 unilaterally implanted in the study eye
|
|---|---|
|
Age, Continuous
|
68.0 years
STANDARD_DEVIATION 9.64 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
62 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
8 participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Singapore
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
9 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 12Population: 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.)
IOP will be measured using a Goldmann applanation tonometer
Outcome measures
| Measure |
XEN45 Glaucoma Treatment System (Hereafter Referred to as XEN)
n=56 Participants
XEN45 unilaterally implanted in the study eye
|
|---|---|
|
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
|
80.5 percentage of participants
Interval 68.4 to 88.8
|
SECONDARY outcome
Timeframe: Month 12Population: Implanted population, defined as all subjects implanted with XEN45, with data at visit.
The number of concomitant IOP-lowering medications following implantation will be compared with the number prior to implantation.
Outcome measures
| Measure |
XEN45 Glaucoma Treatment System (Hereafter Referred to as XEN)
n=56 Participants
XEN45 unilaterally implanted in the study eye
|
|---|---|
|
Change From Baseline the Number of Concomitant IOP-lowering Medications
|
-1.6 Number of medications in study eye
Standard Deviation 1.33
|
Adverse Events
Experimental: XEN45 Glaucoma Treatment System (Hereafter Referred to as XEN)
Serious events: 12 serious events
Other events: 44 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Experimental: XEN45 Glaucoma Treatment System (Hereafter Referred to as XEN)
n=62 participants at risk
XEN45 unilaterally implanted in the study eye
|
|---|---|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
1.6%
1/62 • Number of events 1 • Up tp 12 months after the initiation of XEN45 Implant related procedures
|
|
Eye disorders
ANGLE CLOSURE GLAUCOMA
|
1.6%
1/62 • Number of events 1 • Up tp 12 months after the initiation of XEN45 Implant related procedures
|
|
Eye disorders
CONJUNCTIVAL EROSION
|
4.8%
3/62 • Number of events 3 • Up tp 12 months after the initiation of XEN45 Implant related procedures
|
|
Eye disorders
SUBCONJUNCTIVAL FIBROSIS
|
1.6%
1/62 • Number of events 1 • Up tp 12 months after the initiation of XEN45 Implant related procedures
|
|
Infections and infestations
PNEUMONIA
|
1.6%
1/62 • Number of events 1 • Up tp 12 months after the initiation of XEN45 Implant related procedures
|
|
Infections and infestations
SEPTIC SHOCK
|
1.6%
1/62 • Number of events 1 • Up tp 12 months after the initiation of XEN45 Implant related procedures
|
|
Injury, poisoning and procedural complications
FALL
|
1.6%
1/62 • Number of events 1 • Up tp 12 months after the initiation of XEN45 Implant related procedures
|
|
Injury, poisoning and procedural complications
SKIN LACERATION
|
1.6%
1/62 • Number of events 1 • Up tp 12 months after the initiation of XEN45 Implant related procedures
|
|
Injury, poisoning and procedural complications
SPINAL COMPRESSION FRACTURE
|
1.6%
1/62 • Number of events 1 • Up tp 12 months after the initiation of XEN45 Implant related procedures
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
1.6%
1/62 • Number of events 1 • Up tp 12 months after the initiation of XEN45 Implant related procedures
|
|
Investigations
INTRAOCULAR PRESSURE INCREASED
|
1.6%
1/62 • Number of events 1 • Up tp 12 months after the initiation of XEN45 Implant related procedures
|
|
Metabolism and nutrition disorders
HYPOVOLAEMIA
|
1.6%
1/62 • Number of events 1 • Up tp 12 months after the initiation of XEN45 Implant related procedures
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
1.6%
1/62 • Number of events 1 • Up tp 12 months after the initiation of XEN45 Implant related procedures
|
|
Product Issues
DEVICE PHYSICAL PROPERTY ISSUE
|
1.6%
1/62 • Number of events 1 • Up tp 12 months after the initiation of XEN45 Implant related procedures
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
1.6%
1/62 • Number of events 1 • Up tp 12 months after the initiation of XEN45 Implant related procedures
|
|
Renal and urinary disorders
CALCULUS BLADDER
|
1.6%
1/62 • Number of events 1 • Up tp 12 months after the initiation of XEN45 Implant related procedures
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
1.6%
1/62 • Number of events 1 • Up tp 12 months after the initiation of XEN45 Implant related procedures
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
1.6%
1/62 • Number of events 1 • Up tp 12 months after the initiation of XEN45 Implant related procedures
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
1.6%
1/62 • Number of events 1 • Up tp 12 months after the initiation of XEN45 Implant related procedures
|
|
Vascular disorders
HYPOTENSION
|
1.6%
1/62 • Number of events 1 • Up tp 12 months after the initiation of XEN45 Implant related procedures
|
Other adverse events
| Measure |
Experimental: XEN45 Glaucoma Treatment System (Hereafter Referred to as XEN)
n=62 participants at risk
XEN45 unilaterally implanted in the study eye
|
|---|---|
|
Eye disorders
CHOROIDAL EFFUSION
|
8.1%
5/62 • Number of events 5 • Up tp 12 months after the initiation of XEN45 Implant related procedures
|
|
Eye disorders
CONJUNCTIVAL HAEMORRHAGE
|
9.7%
6/62 • Number of events 6 • Up tp 12 months after the initiation of XEN45 Implant related procedures
|
|
Eye disorders
CONJUNCTIVAL HYPERAEMIA
|
21.0%
13/62 • Number of events 18 • Up tp 12 months after the initiation of XEN45 Implant related procedures
|
|
Eye disorders
CONJUNCTIVAL OEDEMA
|
9.7%
6/62 • Number of events 8 • Up tp 12 months after the initiation of XEN45 Implant related procedures
|
|
Eye disorders
CORNEAL OEDEMA
|
6.5%
4/62 • Number of events 5 • Up tp 12 months after the initiation of XEN45 Implant related procedures
|
|
Eye disorders
DRY EYE
|
8.1%
5/62 • Number of events 6 • Up tp 12 months after the initiation of XEN45 Implant related procedures
|
|
Eye disorders
ERYTHEMA OF EYELID
|
6.5%
4/62 • Number of events 6 • Up tp 12 months after the initiation of XEN45 Implant related procedures
|
|
Eye disorders
EYE PAIN
|
6.5%
4/62 • Number of events 5 • Up tp 12 months after the initiation of XEN45 Implant related procedures
|
|
Eye disorders
EYELID OEDEMA
|
6.5%
4/62 • Number of events 5 • Up tp 12 months after the initiation of XEN45 Implant related procedures
|
|
Eye disorders
FOREIGN BODY SENSATION IN EYES
|
6.5%
4/62 • Number of events 4 • Up tp 12 months after the initiation of XEN45 Implant related procedures
|
|
Eye disorders
PUNCTATE KERATITIS
|
8.1%
5/62 • Number of events 7 • Up tp 12 months after the initiation of XEN45 Implant related procedures
|
|
Eye disorders
VISION BLURRED
|
6.5%
4/62 • Number of events 4 • Up tp 12 months after the initiation of XEN45 Implant related procedures
|
|
Eye disorders
VISUAL ACUITY REDUCED
|
9.7%
6/62 • Number of events 6 • Up tp 12 months after the initiation of XEN45 Implant related procedures
|
|
Injury, poisoning and procedural complications
HYPHAEMA
|
6.5%
4/62 • Number of events 4 • Up tp 12 months after the initiation of XEN45 Implant related procedures
|
|
Investigations
INTRAOCULAR PRESSURE INCREASED
|
40.3%
25/62 • Number of events 33 • Up tp 12 months after the initiation of XEN45 Implant related procedures
|
|
Product Issues
DEVICE OCCLUSION
|
6.5%
4/62 • Number of events 4 • Up tp 12 months after the initiation of XEN45 Implant related procedures
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER