Clinical trial NCT06844240: Efficacy and Safety of XEN63 Gel Implant
Official title: Efficacy and Safety of the XEN63: a Prospective Observational Multicenter Study.
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Glaucoma
Keywords: glaucoma
surgery
XEN63
Lead sponsor: Fondazione G.B. Bietti, IRCCS
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Glaucoma patients attending the hospital

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.

Detailed description: 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. Every patients will be followed for 24 months.

Secondary aims of the study are:

* Evaluating the hypotensive efficacy of the XEN63 12 months after implantation.
* Assessing the safety of the XEN63 device after 12 and 24 months after implantation.
* Comparing the hypotensive efficacy of the XEN63 in glaucomatous patients undergoing the solo procedure and in those undergoing the combo procedure
* Evaluating the quality of life of patients undergoing XEN63 implantation 12 and 24 months after implantation.
* Evaluating the association between factors related to the patient, the surgical technique or post-operative management and the hypotensive efficacy of the device during follow-up.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. Diagnosis of primary or secondary open-angle glaucoma according to the diagnostic criteria of 4th edition of the European Glaucoma Society Guidelines.
3. 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.
4. Informed consent freely given and obtained before the start of the study.
5. 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.

Exclusion Criteria:

1. Closed-angle glaucoma
2. Previous trabeculectomy or valve or tube placement.
3. Presence of conjunctival scarring, previous conjunctival surgery or other conjunctival pathologies (e.g. pterygium) in the target quadrant.
4. Signs of active inflammation (e.g. blepharitis, conjunctivitis, keratitis, uveitis)
5. Active iris neovascularization or presence of iris new vessels within 6 months of the date of surgery
6. Anterior chamber lenses
7. Presence of intraocular silicone oil
8. Vitreous in anterior chamber
9. Altered episcleral venous drainage (e.g. Sturge Webwer syndrome, nanophthalmos)
10. 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)
11. History of predisposition to the formation of keloids.
12. Pregnancy or breastfeeding.

Primary outcomes:
measure: IOP
timeFrame: up to 2 years
measure: Number of hypotensive eye drops
timeFrame: up to 2 years
Secondary outcomes:
measure: IOP
timeFrame: From enrollment to 12 months after surgery
measure: Number of hypotensive eye drops
timeFrame: From enrollment to 12 months after surgery
measure: Complications
timeFrame: up to 2 years
measure: Quality of life after XEN63 implant
timeFrame: up to 2 years
measure: Surgical tecnique
timeFrame: during the intervention/procedure/surgery
measure: Post operative management
timeFrame: up to 2 years
measure: Post operative needling
timeFrame: up to 2 years
measure: Surgical revision
timeFrame: up to 2 years
measure: Glaucoma Symptom Scale
timeFrame: up to 2 years
measure: Surgical technique
timeFrame: during the intervention/procedure/surgery
measure: Post operative management
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Acquaviva delle Fonti
country: Italy
facility: Ente ecclesiastico Ospedale Generale Regionale F. Miulli-Acquaviva delle Fonti Bari
city: Altamura
country: Italy
facility: Ospedale della Murgia "Fabio Perinei"
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII
city: Cagliari
country: Italy
facility: Clinica Oculistica, Ospedale San Giovanni di Dio, Azienda Ospedaliero-Universitaria di Cagliari
city: Cuneo
country: Italy
facility: Ospedale Santa Croce e Carle di Cuneo
city: Firenze
country: Italy
facility: SOD Oculistica - AOU Careggi, Firenze
city: Padova
country: Italy
facility: Clinica Oculistica c/o Azienda Ospedale - Università di Padova
city: Pavia
country: Italy
facility: Dipartimento di Scienze Clinico-Chirurgiche, Diagnostiche e Pediatriche, Fondazione IRCCS policlinico San Matteo di Pavia
city: Pescara
country: Italy
facility: Dipartimento di Medicina e Scienze dell'Invecchiamento, Università G.D'Annunzio di Chieti-Pescara
city: Piacenza
country: Italy
facility: AUSL di Piacenza UOC Oculistica, Ospedale "Guglielmo da Saliceto
city: Pisa
country: Italy
facility: Clinica Oculistica Universitaria Ospedale Santa Chiara, AOUP-Ospedale Cisanello
city: Rome
country: Italy
facility: IRCCS-Fondazione GB Bietti
city: Sassari
country: Italy
facility: Azienda Ospedaliera Universitaria di Sassari, Dipartimento di Medicina, Chirurgia e Farmacologia Università di Sassari
city: Torino
country: Italy
facility: CET Interaziendale AOU Città della Salute e della Scienza di Torino
city: Treviso
country: Italy
facility: Ospedale Ca'Foncello AULSS 2 Marca Trevigiana
city: Tricase
country: Italy
facility: Azienda ospedaliera 'C.Panico' Tricase Lecce
city: Triggiano
country: Italy
facility: Day service di Oculistica del PPA "F.Fallacara"
city: Venezia
country: Italy
facility: UOC Oculistica Aulss 4, Ospedale di San Donà Di Piave.
city: Vercelli
country: Italy
facility: Ospedale S. Andrea, S.O.C. Oculistica
Study officials:
affiliation: IRCCS-Fondazione GB Bietti
name: Francesco Oddone, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.