Efficacy and Safety of XEN63 Gel Implant

NCT ID: NCT06844240

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 96 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-28
• Study Completion Date: 2030-12-31

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.

Conditions

Glaucoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Glaucoma

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

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mario Stirpe

OTHER

Sponsor Role: lead

Responsible Party

Mario Stirpe

Prof

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Francesco Oddone, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

IRCCS-Fondazione GB Bietti

Locations

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

Acquaviva delle Fonti, Italy, Italy

Ospedale della Murgia "Fabio Perinei"

Altamura, Italy, Italy

Ospedale Santa Croce e Carle di Cuneo

Cuneo, Italy, Italy

SOD Oculistica - AOU Careggi, Firenze

Florence, Italy, Italy

AUSL di Piacenza UOC Oculistica, Ospedale "Guglielmo da Saliceto

Piacenza, Italy, Italy

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

Sassari, Italy, Italy

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

Venezia, Italy, Italy

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

Vercelli, Italy, Italy

ASST Papa Giovanni XXIII

Bergamo, , Italy

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

Cagliari, , Italy

Clinica Oculistica c/o Azienda Ospedale - Università di Padova

Padua, , Italy

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

Pavia, , Italy

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

Pescara, , Italy

Clinica Oculistica Universitaria Ospedale Santa Chiara, AOUP-Ospedale Cisanello

Pisa, , Italy

IRCCS-Fondazione GB Bietti

Rome, , Italy

CET Interaziendale AOU Città della Salute e della Scienza di Torino

Torino, , Italy

Ospedale Ca'Foncello AULSS 2 Marca Trevigiana

Treviso, , Italy

Azienda ospedaliera 'C.Panico' Tricase Lecce

Tricase, , Italy

Day service di Oculistica del PPA "F.Fallacara"

Triggiano, , Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 28850575 (View on PubMed)

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.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

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Other Identifiers

GLC06-23

Identifier Type: -

Identifier Source: org_study_id