XEN45 in Angle Closure Glaucoma
Research type
Research Study
Full title
A Prospective, Multicentre Clinical Trial Designed to Evaluate the Safety and Effectiveness of the XEN45 Glaucoma Treatment System in Patients with Angle Closure Glaucoma.
IRAS ID
240879
Contact name
Maria Francesca Cordeiro
Contact email
Sponsor organisation
Allergan
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 3 months, 2 days
Research summary
Glaucoma is an eye condition where the optic nerve is damaged by the high pressure of the fluid in the eye (aqueous humour). Aqueous humour is produced by a ring of eye tissue called the ciliary body, located behind the iris (coloured part of the eye). It flows through the pupil and drains out through a spongy network of holes called the trabecular meshwork (which sits in the angle formed where the iris meets the cornea). In Angle Closure Glaucoma (ACG), the outer edge of the iris and cornea come in contact, closing the drainage angle. This prevents the aqueous humour from draining and causes the pressure in the eye to build up.
Currently available treatment for ACG consists of procedures to reduce eye pressure, including laser treatment, lens extraction, eye pressure-lowering medications, and incisional surgeries. There are no minimally invasive glaucoma surgery options available for ACG. XEN45 Glaucoma Treatment System (referred to as XEN) potentially alleviates this unmet need. XEN comprises of the Gel Implant and the Injector. The Gel implant is a soft gelatinous implant, approximately 6 mm long and as wide as a human hair. After implantation in the eye, it acts as a conduit for the drainage of aqueous humour in the eye.
The current study, sponsored by Allergan, is a prospective, multicentre, single arm, open-label (the participants and study team will know which treatment the participant is assigned to) clinical trial in patients with ACG. Approximately 65 patients will be implanted with XEN in one eye and followed for 12 months to evaluate its safety and effectiveness. Participants will be enrolled at approximately 15 research sites in the Asia-Pacific and European regions.
REC name
London - Stanmore Research Ethics Committee
REC reference
18/LO/0797
Date of REC Opinion
23 Jul 2018
REC opinion
Further Information Favourable Opinion