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GlaucomaXEN63NCT06844240

Efficacy and Safety of XEN63 Gel Implant

An observational study of Glaucoma, run by Mario Stirpe at 19 sites in Italy.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glaucoma
How many people
96 participants
Where
19 sitesItaly
Study dates
28 Nov 2024to 31 Dec 2030
How long will I take part?
24 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Glaucoma patients attending the hospital

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 12Show fewer
  • 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.

Trial locations and contacts

19 sites in 1 country. Contact the study team or a site near you to ask about taking part.

19 sites in 1 country

Italy19 sites

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

    Acquaviva delle Fonti, Italy, 70021

  • Ospedale della Murgia "Fabio Perinei"

    Altamura, Italy, 70022

  • ASST Papa Giovanni XXIII

    Bergamo

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

    Cagliari

  • Ospedale Santa Croce e Carle di Cuneo

    Cuneo, Italy, 12100

  • SOD Oculistica - AOU Careggi, Firenze

    Florence, Italy, 50134

  • Clinica Oculistica c/o Azienda Ospedale - Università di Padova

    Padova

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

    Pavia

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

    Pescara

  • AUSL di Piacenza UOC Oculistica, Ospedale "Guglielmo da Saliceto

    Piacenza, Italy, 29121

  • Clinica Oculistica Universitaria Ospedale Santa Chiara, AOUP-Ospedale Cisanello

    Pisa

  • IRCCS-Fondazione GB Bietti

    Rome, 00184

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

    Sassari, Italy, 07100

  • CET Interaziendale AOU Città della Salute e della Scienza di Torino

    Torino

  • Ospedale Ca'Foncello AULSS 2 Marca Trevigiana

    Treviso

  • Azienda ospedaliera 'C.Panico' Tricase Lecce

    Tricase

  • Day service di Oculistica del PPA "F.Fallacara"

    Triggiano

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

    Venezia, Italy, 30027

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

    Vercelli, Italy

Other trials in Italy

About this study

Official title: Efficacy and Safety of the XEN63: a Prospective Observational Multicenter Study.

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.

Read the 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
Keywords
glaucoma, surgery, XEN63
Medical subject headings
Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06844240
Study groupRoleWhat they receive
GlaucomaDiagnosis of primary or secondary open-angle glaucoma according to the diagnostic criteria of 4th edition of the European Glaucoma Society Guidelines.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. IOP

    IOP values before and after 24 months of XEN63 implant.

    Measured: up to 2 years

  2. Number of hypotensive eye drops

    Number of hypotensive eye drops

    Measured: up to 2 years

Secondary outcomes (11)

  1. IOP

    IOP values before and after 12 months of XEN63 implant.

    Measured: From enrollment to 12 months after surgery

  2. Number of hypotensive eye drops

    Number of hypotensive eye drops before and after 12 months of XEN63 implant

    Measured: From enrollment to 12 months after surgery

  3. Complications

    • Type and number of intraoperative and postoperative complications.

    Measured: up to 2 years

  4. Quality of life after XEN63 implant

    Quality of life questionnaire (National Eye Institute Visual Function Questionnaire-25) scores over time. The minimum value is 0, the maximum value is 100. Higher score means a better outcome.

    Measured: up to 2 years

  5. Surgical tecnique

    Data on surgical technique: site of XEN63 implant

    Measured: during the intervention/procedure/surgery

  6. Post operative management

    Post operative treatment: type of steroids used

    Measured: up to 2 years

  7. Post operative needling

    Number of needling

    Measured: up to 2 years

  8. Surgical revision

    Number of surgical revision

    Measured: up to 2 years

  9. Glaucoma Symptom Scale

    A brief symptom survey specific for persons with glaucoma. This score is transformed to a 0 to 100 scale, with 0 representing presence of a very bothersome problem and 100 representing absence of a problem.

    Measured: up to 2 years

  10. Surgical technique

    Data on surgical technique: type of viscoelastic used

    Measured: during the intervention/procedure/surgery

  11. Post operative management

    Type and number of hypotensive drops used to control IOP after surgery if needed.

    Measured: up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2025
  2. Study start28 Nov 2024
  3. Primary completion31 Dec 2030 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
96 participants (estimated)
Target duration
24 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT06844240
Sponsor's protocol ID
GLC06-23
Acronym
XEN63
Status last verified
May 2026
First submitted
31 Jan 2025
Last updated
1 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 33921311

  • 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.

    PubMed 28850575

  • 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.

    PubMed 12799246

  • 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.

    PubMed 15118473

  • 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.

    PubMed 24874999

  • 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.

    PubMed 15126172

  • 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.

    PubMed 17542978

  • 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.

    PubMed 15939389

Questions about this trial

What is this clinical trial studying?

An observational study of Glaucoma, run by Mario Stirpe at 19 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

IOP (time frame: up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06844240, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.

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