Trial Outcomes & Findings for Ab Interno Gelatin Stent With Mitomycin C Using Targeted Supra-tenon's Placement (NCT NCT04454138)
NCT ID: NCT04454138
Last Updated: 2020-08-14
Results Overview
Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤14 (mmHg) on no medications
Recruitment status
COMPLETED
Target enrollment
142 participants
Primary outcome timeframe
Post op year 1
Results posted on
2020-08-14
Participant Flow
Participant milestones
| Measure |
Non-targeted Placement of XEN 45
Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement.
XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area
|
Targeted Supratenon's Placement of XEN 45
Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency.
XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
77
|
|
Overall Study
COMPLETED
|
65
|
77
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ab Interno Gelatin Stent With Mitomycin C Using Targeted Supra-tenon's Placement
Baseline characteristics by cohort
| Measure |
Non-targeted Placement of XEN 45
n=65 Participants
Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement.
XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area
|
Targeted Supratenon's Placement of XEN 45
n=77 Participants
Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency.
XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area
|
Total
n=142 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.4 years
n=5 Participants
|
78 years
n=7 Participants
|
70.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
41 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
65 participants
n=5 Participants
|
77 participants
n=7 Participants
|
142 participants
n=5 Participants
|
|
Diabetic
|
22 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Preoperative Best Corrected Visual Acuity (BCVA)
|
0.2 logMAR
n=5 Participants
|
0.3 logMAR
n=7 Participants
|
0.2 logMAR
n=5 Participants
|
|
Number of Patients who received XEN 45 in Left Eye
|
32 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
IOP > 21 mmHg
|
32 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
IOP median
|
21 mmHg
n=5 Participants
|
22 mmHg
n=7 Participants
|
21 mmHg
n=5 Participants
|
|
Medication Classes
|
4 Medication Classes
n=5 Participants
|
4 Medication Classes
n=7 Participants
|
4 Medication Classes
n=5 Participants
|
|
Primary Open Angle Glaucoma
|
48 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Pseudoexfoliation
|
7 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Pigment Dispersion Glaucoma
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Primary Angle Closure Glaucoma
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Combined Mechanism Glaucoma
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Cup to Disk Ratio
|
0.9 Ratio
n=5 Participants
|
0.8 Ratio
n=7 Participants
|
0.8 Ratio
n=5 Participants
|
|
Preoperative Mean Deviation on Visual Field to Normal Population
|
-8.4 decibel
n=5 Participants
|
-1.7 decibel
n=7 Participants
|
-4 decibel
n=5 Participants
|
|
Mild Disease
|
22 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Moderate to Severe Disease
|
42 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Laser Peripheral Iridotomy
|
8 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Laser Trabeculoplasty
|
47 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Concomitant Cataract Surgery
|
24 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Post op year 1Population: Per protocol population
Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤14 (mmHg) on no medications
Outcome measures
| Measure |
Non-targeted Placement of XEN 45
n=65 Participants
Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement.
XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area
|
Targeted Supratenon's Placement of XEN 45
n=77 Participants
Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency.
XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area
|
|---|---|---|
|
Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement.
|
20 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: Post op Year 1Population: Per protocol population
Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤14 (mmHg) +/- Medications
Outcome measures
| Measure |
Non-targeted Placement of XEN 45
n=65 Participants
Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement.
XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area
|
Targeted Supratenon's Placement of XEN 45
n=77 Participants
Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency.
XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area
|
|---|---|---|
|
Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 2.
|
33 Participants
|
22 Participants
|
PRIMARY outcome
Timeframe: Post op year 1Population: Per protocol polulation
Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤17 (mmHg) on no medications
Outcome measures
| Measure |
Non-targeted Placement of XEN 45
n=65 Participants
Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement.
XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area
|
Targeted Supratenon's Placement of XEN 45
n=77 Participants
Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency.
XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area
|
|---|---|---|
|
Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 3.
|
28 Participants
|
18 Participants
|
PRIMARY outcome
Timeframe: Post op Year 1Population: per protocol population
Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤17 (mmHg) +/- medication
Outcome measures
| Measure |
Non-targeted Placement of XEN 45
n=65 Participants
Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement.
XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area
|
Targeted Supratenon's Placement of XEN 45
n=77 Participants
Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency.
XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area
|
|---|---|---|
|
Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 4.
|
41 Participants
|
26 Participants
|
PRIMARY outcome
Timeframe: Post op Year 1Population: per protocol population
Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤21 (mmHg) on no medications
Outcome measures
| Measure |
Non-targeted Placement of XEN 45
n=65 Participants
Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement.
XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area
|
Targeted Supratenon's Placement of XEN 45
n=77 Participants
Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency.
XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area
|
|---|---|---|
|
Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 5.
|
31 Participants
|
19 Participants
|
PRIMARY outcome
Timeframe: Post op year 1Population: per protocol population
Mean change in IOP from baseline, IOP thresholds of ≥6 and ≤14 (mmHg) +/- medications
Outcome measures
| Measure |
Non-targeted Placement of XEN 45
n=65 Participants
Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement.
XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area
|
Targeted Supratenon's Placement of XEN 45
n=77 Participants
Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency.
XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area
|
|---|---|---|
|
Postoperative Intraocular Pressure Changes Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Nontargeted Placement 6.
|
47 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Post op year 1Population: Per protocol population
Presence or absence of the following complications: i. Starting after POM1: shallow AC w/ iridocorneal touch, any hyphema, corneal edema, wound leak/dehiscience, choroidal effusion, malignant glaucoma, dellen/non-healing epithelial defect, ptosis, diplopia. ii. At any point: additional glaucoma surgery, loss of light perception vision, vitreous hemorrhage, ≥2mm hyphema, hypotony maculopathy, implant migration/blockage/exposure/extrusion, macular edema, choroidal effusion/hemorrhage requiring drainage, suprachoroidal hemorrhage, retinal detachment, suture abscess/blebitis/endophthalmitis
Outcome measures
| Measure |
Non-targeted Placement of XEN 45
n=65 Participants
Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement.
XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area
|
Targeted Supratenon's Placement of XEN 45
n=77 Participants
Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency.
XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area
|
|---|---|---|
|
Number of Participants With Postoperative Complications Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Non-targeted Placement.
|
35 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: Post op year 1Population: per protocol population
Presence or absence of the following management interventions (not considered complications): bleb needling, AC reformation, suture release, digital ocular compression, use of glaucoma medications, or laser/tpa to blocked ostomy or lumen.
Outcome measures
| Measure |
Non-targeted Placement of XEN 45
n=65 Participants
Implantation of the XEN-45 gelatin microstent within the subconjunctival space, avoiding intra-tenon's placement.
XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area
|
Targeted Supratenon's Placement of XEN 45
n=77 Participants
Placement of Xen-45 gelatin microstent in the supra-tenon's space to maximize aqueous outflow, while preventing obstruction, limiting fibrosis of the bleb, and promoting long-term patency.
XEN-45 gelatin microstent: Placement either in the subconjunctival space or supratenon's area
|
|---|---|---|
|
Number of Participants With Postoperative Interventions Between Targeted Supratenon's Placement of XEN-45 Gelatin Stent and Non-targeted Placement.
|
32 Participants
|
40 Participants
|
Adverse Events
Non-targeted Placement of XEN 45
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Targeted Supratenon's Placement of XEN 45
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place