NCT02036541

Brief Summary

To establish the safety and performance of the AqueSys XEN 45 Glaucoma Implant in eyes with refractory glaucoma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 13, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
10 months until next milestone

Results Posted

Study results publicly available

June 1, 2017

Completed
Last Updated

June 1, 2017

Status Verified

May 1, 2017

Enrollment Period

3.1 years

First QC Date

January 13, 2014

Results QC Date

May 1, 2017

Last Update Submit

May 30, 2017

Conditions

GlaucomaGlaucoma, Open Angle

Keywords

Glaucoma ImplantTrabeculectomyPOAGPrimary Open Angle GlaucomaPseudoexfoliation GlaucomaPigmentary Glaucoma

Outcome Measures

Primary Outcomes (2)

  • Proportion of Subjects Achieving a 20% or Greater Reduction in IOP From Baseline on the Same or Less Number of Medications

    Proportion of subjects achieving a 20% or greater reduction in IOP from baseline on the same or less number of medications. Subjects who underwent a glaucoma-related secondary surgical intervention prior to the 12-month visit were considered failures in this analysis.

    12 Months

  • Mean Change in IOP From Baseline

    Mean change in IOP from baseline was calculated for subjects who completed the 12-month visit and the worst within-eye IOP was used for subjects who underwent a glaucoma-related secondary surgical intervention.

    12 Months

Study Arms (1)

AqueSys XEN 45 Glaucoma Implant

EXPERIMENTAL
Device: AqueSys XEN 45 Glaucoma Implant

Interventions

AqueSys XEN 45 Glaucoma ImplantDEVICE

Placement of the AqueSys XEN 45 Glaucoma Implant in the study eye

AqueSys XEN 45 Glaucoma Implant

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Refractory Glaucoma
  • Maximally-tolerated medicated IOP at two preoperative visits of ≥20 mmHg and ≤35 mmHg
  • Visual field mean deviation score of -3 dB or worse
  • Shaffer Angle Grade ≥ 3
  • Area of free, healthy and mobile conjunctiva in the targeted quadrant

You may not qualify if:

  • Active Neovascular Glaucoma
  • Previous glaucoma shunt/valve in the targeted quadrant
  • History of corneal surgery, opacities or disease/pathology
  • Anticipated need for ocular surgery
  • Non-study eye with BCVA of 20/200 or worse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

George R. Reiss, MD PC

Glendale, Arizona, 85306, United States

Location

Vold Vision

Fayetteville, Arkansas, 72704, United States

Location

Montebello Eye Center

Montebello, California, 90640, United States

Location

San Diego Eye Care Center

Oceanside, California, 92056, United States

Location

Palo Alto Eye Group

Palo Alto, California, 94306, United States

Location

Eye Center of Northern Colorado

Fort Collins, Colorado, 80525, United States

Location

Stiles Eyecare Excellence & Glaucoma Institute

Overland Park, Kansas, 66213, United States

Location

Washington University in St. Louis, Department of Ophthalmology

St Louis, Missouri, 63110, United States

Location

New York Eye and Ear Infirmary

New York, New York, 10003, United States

Location

Glaucoma Associates of Texas

Dallas, Texas, 75231, United States

Location

R and R Eye Research, LLC

San Antonio, Texas, 78229, United States

Location

Spokane Eye Clinic

Spokane, Washington, 99204, United States

Location

Related Publications (1)

  • Ozal SA, Kaplaner O, Basar BB, Guclu H, Ozal E. An innovation in glaucoma surgery: XEN45 gel stent implantation. Arq Bras Oftalmol. 2017 Nov-Dec;80(6):382-385. doi: 10.5935/0004-2749.20170093.

    PMID: 29267575DERIVED

MeSH Terms

Conditions

GlaucomaGlaucoma, Open-AngleExfoliation Syndrome

Condition Hierarchy (Ancestors)

Ocular HypertensionEye DiseasesIris DiseasesUveal Diseases

Results Point of Contact

Title
Rupali Nangia
Organization
Allergan plc
rupali.nangia@allergan.com
714-246-6020

Study Officials

  • Richard A Lewis, M.D.

    Grutzmacher, Lewis & Sierra Surgical Eye Specialists

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2014

First Posted

January 15, 2014

Study Start

January 1, 2013

Primary Completion

February 1, 2016

Study Completion

August 1, 2016

Last Updated

June 1, 2017

Results First Posted

June 1, 2017

Record last verified: 2017-05

Locations

US(12)