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New eye implant aims to lower glaucoma pressure

NCT ID NCT06844240

Disease control Sponsor: Mario Stirpe Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a device called XEN63, a small implant placed in the eye to help drain fluid and lower pressure in people with glaucoma. Researchers will follow 96 patients for 24 months to see if the implant safely reduces eye pressure and the need for daily eye drops. The study is observational, meaning patients receive the implant as part of routine care, and no new treatment is being tested.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
XEN63 implant
What this could lead to
If successful, this could confirm that the XEN63 implant safely lowers eye pressure and reduces the need for daily eye drops in glaucoma patients.
What could go wrong
This is an observational study, not a controlled trial, so results may be less definitive. Complications or limited long-term benefit are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 96 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Glaucoma patients attending the hospital

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

glaucoma open-angle glaucoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Glaucoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    19 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • ASST Papa Giovanni XXIII

    Bergamo, Italy

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

    Piacenza, Italy, 29121, Italy

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

    Sassari, Italy, 07100, Italy

  • Azienda ospedaliera 'C.Panico' Tricase Lecce

    Tricase, Italy

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

    Torino, Italy

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

    Pisa, Italy

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

    Padova, Italy

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

    Cagliari, Italy

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

    Triggiano, Italy

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

    Pescara, Italy

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

    Pavia, Italy

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

    Acquaviva delle Fonti, Italy, 70021, Italy

  • IRCCS-Fondazione GB Bietti

    Rome, 00184, Italy

  • Ospedale Ca'Foncello AULSS 2 Marca Trevigiana

    Treviso, Italy

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

    Vercelli, Italy, Italy

  • Ospedale Santa Croce e Carle di Cuneo

    Cuneo, Italy, 12100, Italy

  • Ospedale della Murgia "Fabio Perinei"

    Altamura, Italy, 70022, Italy

  • SOD Oculistica - AOU Careggi, Firenze

    Florence, Italy, 50134, Italy

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

    Venezia, Italy, 30027, Italy

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