Efficacy and Safety of XEN63 Gel Implant

NCT06844240 | Enrolling By Invitation

• 1 other identifier: GLC06-23
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 19

Brief Summary

The study is prospective, observational, multicenter and has the aim of evaluating the efficacy and safety of the XEN63 implant in patients with primary or secondary glaucoma who require surgery in association or not with cataract surgery, for IOP not controlled by medical therapy, disease progression or intolerance to topical therapy, comparing IOP values before and 24 months after implantation.

Conditions

Glaucoma

Keywords

glaucoma; surgery; XEN63

Outcome Measures

Primary Outcomes (2)

• IOP

  IOP values before and after 24 months of XEN63 implant.

  up to 2 years

• Number of hypotensive eye drops

  Number of hypotensive eye drops

  up to 2 years

Secondary Outcomes (11)

• IOP

  From enrollment to 12 months after surgery

• Number of hypotensive eye drops

  From enrollment to 12 months after surgery

• Complications

  up to 2 years

• Quality of life after XEN63 implant

  up to 2 years

• Surgical tecnique

  during the intervention/procedure/surgery

Study Arms (1)

Glaucoma

Diagnosis of primary or secondary open-angle glaucoma according to the diagnostic criteria of 4th edition of the European Glaucoma Society Guidelines.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Glaucoma patients attending the hospital

You may qualify if:

• Age ≥ 18 years
• Diagnosis of primary or secondary open-angle glaucoma according to the diagnostic criteria of 4th edition of the European Glaucoma Society Guidelines.
• Need for XEN63 implantation for IOP not controlled by medical therapy, progression of disease or intolerance to topical therapy, in association or not with cataract surgery.
• Informed consent freely given and obtained before the start of the study.
• The participant has the ability to understand and the willingness to follow the study instructions and is likely to complete all required visits and procedures.

You may not qualify if:

• Closed-angle glaucoma
• Previous trabeculectomy or valve or tube placement.
• Presence of conjunctival scarring, previous conjunctival surgery or other conjunctival pathologies (e.g. pterygium) in the target quadrant.
• Signs of active inflammation (e.g. blepharitis, conjunctivitis, keratitis, uveitis)
• Active iris neovascularization or presence of iris new vessels within 6 months of the date of surgery
• Anterior chamber lenses
• Presence of intraocular silicone oil
• Vitreous in anterior chamber
• Altered episcleral venous drainage (e.g. Sturge Webwer syndrome, nanophthalmos)
• Known or suspected allergy or sensitization to medications required for the surgical procedure or some component of the device (e.g. glutaraldehyde or porcine derivatives)
• History of predisposition to the formation of keloids.
• Pregnancy or breastfeeding.

Sponsors & Collaborators

• Mario Stirpe: lead

Study Sites (19)

Ente ecclesiastico Ospedale Generale Regionale F. Miulli-Acquaviva delle Fonti Bari

Acquaviva delle Fonti, Italy, 70021, Italy

Location

Ospedale della Murgia "Fabio Perinei"

Altamura, Italy, 70022, Italy

Location

Ospedale Santa Croce e Carle di Cuneo

Cuneo, Italy, 12100, Italy

Location

SOD Oculistica - AOU Careggi, Firenze

Florence, Italy, 50134, Italy

Location

AUSL di Piacenza UOC Oculistica, Ospedale "Guglielmo da Saliceto

Piacenza, Italy, 29121, Italy

Location

Azienda Ospedaliera Universitaria di Sassari, Dipartimento di Medicina, Chirurgia e Farmacologia Università di Sassari

Sassari, Italy, 07100, Italy

Location

UOC Oculistica Aulss 4, Ospedale di San Donà Di Piave.

Venezia, Italy, 30027, Italy

Location

Ospedale S. Andrea, S.O.C. Oculistica

Vercelli, Italy, Italy

Location

ASST Papa Giovanni XXIII

Bergamo, Italy

Location

Clinica Oculistica, Ospedale San Giovanni di Dio, Azienda Ospedaliero-Universitaria di Cagliari

Cagliari, Italy

Location

Clinica Oculistica c/o Azienda Ospedale - Università di Padova

Padova, Italy

Location

Dipartimento di Scienze Clinico-Chirurgiche, Diagnostiche e Pediatriche, Fondazione IRCCS policlinico San Matteo di Pavia

Pavia, Italy

Location

Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G.D'Annunzio di Chieti-Pescara

Pescara, Italy

Location

Clinica Oculistica Universitaria Ospedale Santa Chiara, AOUP-Ospedale Cisanello

Pisa, Italy

Location

IRCCS-Fondazione GB Bietti

Rome, 00184, Italy

Location

CET Interaziendale AOU Città della Salute e della Scienza di Torino

Torino, Italy

Location

Ospedale Ca'Foncello AULSS 2 Marca Trevigiana

Treviso, Italy

Location

Azienda ospedaliera 'C.Panico' Tricase Lecce

Tricase, Italy

Location

Day service di Oculistica del PPA "F.Fallacara"

Triggiano, Italy

Location

Related Publications (8)

• Fea AM, Menchini M, Rossi A, Posarelli C, Malinverni L, Figus M. Early Experience with the New XEN63 Implant in Primary Open-Angle Glaucoma Patients: Clinical Outcomes. J Clin Med. 2021 Apr 12;10(8):1628. doi: 10.3390/jcm10081628.

  PMID: 33921311 BACKGROUND

• Lavia C, Dallorto L, Maule M, Ceccarelli M, Fea AM. Minimally-invasive glaucoma surgeries (MIGS) for open angle glaucoma: A systematic review and meta-analysis. PLoS One. 2017 Aug 29;12(8):e0183142. doi: 10.1371/journal.pone.0183142. eCollection 2017.

  PMID: 28850575 BACKGROUND

• Fannin LA, Schiffman JC, Budenz DL. Risk factors for hypotony maculopathy. Ophthalmology. 2003 Jun;110(6):1185-91. doi: 10.1016/S0161-6420(03)00227-6.

  PMID: 12799246 BACKGROUND

• Bashford KP, Shafranov G, Shields MB. Bleb revision for hypotony maculopathy after trabeculectomy. J Glaucoma. 2004 Jun;13(3):256-60. doi: 10.1097/00061198-200406000-00015.

  PMID: 15118473 BACKGROUND

• Bitrian E, Song BJ, Caprioli J. Bleb revision for resolution of hypotony maculopathy following primary trabeculectomy. Am J Ophthalmol. 2014 Sep;158(3):597-604.e1. doi: 10.1016/j.ajo.2014.05.021. Epub 2014 May 27.

  PMID: 24874999 BACKGROUND

• Oyakhire JO, Moroi SE. Clinical and anatomical reversal of long-term hypotony maculopathy. Am J Ophthalmol. 2004 May;137(5):953-5. doi: 10.1016/j.ajo.2003.11.019.

  PMID: 15126172 BACKGROUND

• Costa VP, Arcieri ES. Hypotony maculopathy. Acta Ophthalmol Scand. 2007 Sep;85(6):586-97. doi: 10.1111/j.1600-0420.2007.00910.x. Epub 2007 Jun 2.

  PMID: 17542978 BACKGROUND

• Jampel HD, Musch DC, Gillespie BW, Lichter PR, Wright MM, Guire KE; Collaborative Initial Glaucoma Treatment Study Group. Perioperative complications of trabeculectomy in the collaborative initial glaucoma treatment study (CIGTS). Am J Ophthalmol. 2005 Jul;140(1):16-22. doi: 10.1016/j.ajo.2005.02.013.

  PMID: 15939389 BACKGROUND

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Francesco Oddone, MD, PhD

  IRCCS-Fondazione GB Bietti

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 25, 2025
• Study Start: November 28, 2024
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (19)