Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion

Description

Summary

The aim of this study is to compare the effectiveness and safety of XEN to trabeculectomy in subjects with open angle glaucoma refractory to topical medical therapy

Official Title

XEN45 Gel Stent Versus Trabeculectomy in Open-angle Glaucoma

Details

This is a multi-center, randomized, parallel group, prospective, open-label clinical trial to evaluate the ability of XEN to reduce IOP and reduce the amount of topical IOP-lowering medications in subjects poorly controlled on topical therapy. Patients will be randomized 2:1, resulting in approximately 190 eyes being implanted with XEN and approximately 95 eyes will be receiving trabeculectomy. Subjects will be screened for enrollment and eligible candidates will be approached to ascertain interest in study participation. Study duration will be approximately 12 months.

Keywords

Glaucoma XEN group Trabeculectomy

Eligibility

You can join if…

Open to people ages 18 years and up

  • Open-angle glaucoma where the Intraocular pressure (IOP) is not controlled when using topical IOP-lowering glaucoma medication
  • Best-corrected baseline Snellen visual acuity of 20/80 or better
  • Visual field mean deviation no worse than -15.0 dB
  • Medicated IOP ≥18 mmHg and ≤44 mmHg
  • Subjects not anticipated to require any ocular surgery (e.g., cataract surgery) in either eye up to 12 months from the time of inclusion
  • Area of healthy, free, and mobile conjunctiva in the target area (superior bulbar conjunctiva)
  • Trabecular meshwork must be visible (with Shaffer angle grade ≥2 in the target quadrant)
  • Failed ab-interno canal or suprachoroidal MIGS procedures (such as i-Stent, CyPass, GATT, ABiC, Kahook dual blade goniotomy, etc.) are allowed.

You CAN'T join if...

  • Subject has active neovascular, uveitic or angle recession glaucoma or any glaucoma associated with vascular disorders
  • Subject has had prior ab externo incisional glaucoma surgery (such as trabeculectomy, viscocanalostomy, canaloplasty, tube shunts of any type, collagen implants, etc.), conjunctival filtering surgery, transscleral cycloablative procedures (such as cyclophotocoagulation, micro pulse cyclophotocoagulation, cryotherapy, UC3, etc.) or prior major conjunctival surgery (i.e., scleral buckle)

-. Clinically significant inflammation or infection within 30 days before the preoperative visit (e.g., blepharitis, conjunctivitis, severe ocular surface disease, keratitis, uveitis, herpes simplex infection)

  • Presence of conjunctival scarring or prior conjunctival surgery or other conjunctival pathologies (e.g., pterygium) in the target area
  • History of corneal surgery, corneal opacities, or corneal disease
  • Central corneal thickness ≤490μm or ≥620μm
  • Vitreous present in the anterior chamber
  • Aphakic
  • Subject has had prior intraocular surgery in either eye within ≤3 months before the preoperative visit (including phacoemulsification)
  • History of complicated cataract surgery (e.g. with visual impairment, e.g. vitreous loss, ACIOL, perhaps sutured IOL or scleral fixated IOL, prior CME, etc.)
  • Presence of intraocular silicone oil
  • Active diabetic retinopathy, proliferative retinopathy, choroidal neovascularization, branch retinal vein occlusion, central retinal vein occlusion, geographic atrophy, or other ophthalmic disease or disorder that could confound study results or impaired episcleral venous drainage (e.g., Sturge-Weber or nanophthalmos, Axenfeld-Reiger, ICE, etc.
  • Known or suspected allergy or sensitivity to drugs required for the protocol (including anesthesia), or any of the device components (e.g., bovine or porcine products, or glutaraldehyde)
  • Pregnant or nursing women and those planning a pregnancy during the study period.
  • Participation in another drug or device clinical trial concluding within 30 days before the preoperative visit

Locations

  • UCSD- Shiley Eye Center not yet accepting patients
    La Jolla California 92093 United States
  • Sacramento Eye Consultants not yet accepting patients
    Sacramento California 95815 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Allergan
Links
Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR‐CTRegistration@Allergan.com for assistance
ID
NCT03654885
Phase
Phase 4
Study Type
Interventional
Last Updated