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A Study to Assess Adverse Events and Effectiveness of Gel Stent (XEN63) Implantation Using Ab Interno and Ab Externo Approaches in Adult Participants With Glaucoma

Study on safety and effectiveness of Gel Stent for glaucoma treatment.

Recruiting
45 years and older
All
Phase 3

Glaucoma can cause blindness and is the second most common cause after cataracts. This study looks at how safe and effective a gel stent, called XEN63, is for treating glaucoma. The study will compare two methods of placing the stent: ab interno (inside the eye) and ab externo (outside the eye). The study will check for any bad side effects and will also measure the eye pressure, known as intraocular pressure (IOP).

The study will have about 130 adults with glaucoma, age 45 or older, from around the world. Participants will be in one of two groups, receiving the XEN63 stent either inside or outside the eye on the first day. They will be followed for 12 months with regular hospital or clinic visits to monitor the safety and effects of the stent through eye exams and medical checks.

  • The study lasts for 12 months with regular check-ups.
  • Participants are divided into two groups for different treatments.
  • The study involves eye procedures that carry some risks.
Study details
    Primary Open Angle Glaucoma

NCT06822738

AbbVie

16 February 2025

Step 1 Get in touch with the nearest study center
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  • You can expect the study team to contact you via email or phone in the next few days.
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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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