Gel Stent for Glaucoma
Recruiting in Palo Alto (17 mi)
+7 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: AbbVie
Must be taking: IOP-lowering medications
Disqualifiers: Angle-closure glaucoma, Secondary open-angle glaucoma, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?Glaucoma is the second most common cause of blindness in the world, second only to cataracts. This study will assess how safe and effective a glaucoma gel stent is when implanted using the ab interno (inside the eye) and ab externo (outside the eye) approach. Adverse events and intraocular pressure will be assessed.
XEN63 is an investigational device for the treatment of intraocular pressure (IOP) in patients with glaucoma when both medical and conventional surgical treatments have failed (for US approval) and when medical treatments have failed (for outside US \[OUS\] approval). Participants will be placed in one of two groups called study arms. One group will receive the XEN63 gel stent ab interno (inside the eye) and the other group will receive the XEN63 gel stent ab externo (outside the eye). Approximately 130 participants aged 45 years or older with glaucoma will be enrolled in this study at approximately 32 sites in select countries in North America and Europe.
Participants will receive XEN63 implanted using either the ab interno approach or the ab externo approach on Day 1 and will be followed for 12 months.
Participants will attend regular visits during the study at a hospital or clinic. The safety and effect of the gel stent on your glaucoma will be checked by medical assessments and eye examinations.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop your current medications. However, it mentions that participants have glaucoma uncontrolled by maximal medical therapy, which suggests you may continue your current medications if they are not effectively managing your condition.
What data supports the effectiveness of the XEN63 Glaucoma Treatment System?
Research shows that the XEN63 Gel Stent is effective in reducing eye pressure in patients with open-angle glaucoma, which is a common form of glaucoma. Studies have followed patients for up to five years, indicating that the treatment can help manage the condition over the long term.
12345Is the Gel Stent for Glaucoma safe for humans?
The XEN Gel Stent, used for treating glaucoma, has been studied for safety and generally shows a good safety profile in humans. Some complications like intraoperative bleeding and stent blockage have been reported, but these were managed effectively.
15678How is the XEN63 Gel Stent treatment different from other glaucoma treatments?
The XEN63 Gel Stent is a minimally invasive surgical treatment for glaucoma that involves implanting a tiny tube to help drain fluid from the eye, reducing pressure. This approach is less invasive than traditional surgeries and offers a unique option for managing open-angle glaucoma.
12589Eligibility Criteria
This trial is for adults aged 45 or older with glaucoma, specifically when medical and conventional surgical treatments haven't worked (in the US) or when only medical treatments have failed (outside the US). Participants will be enrolled worldwide and must attend regular hospital or clinic visits.Inclusion Criteria
My eye has glaucoma that hasn't improved with treatment.
I have had glaucoma surgery or treatments that did not work.
I have conditions that could cause standard glaucoma surgery to fail.
+1 more
Exclusion Criteria
I have had angle-closure glaucoma without corrective surgery.
I have had open-angle glaucoma in my right eye.
I have active eye inflammation.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive XEN63 gel stent implantation using either the ab interno or ab externo approach
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment through regular visits and assessments
12 months
Regular visits (in-person)
Participant Groups
The study tests the safety and effectiveness of a gel stent called XEN63 in treating glaucoma. It compares two ways of implanting it: ab interno (inside the eye) versus ab externo (outside the eye). About 130 participants will receive this treatment on Day 1 and be monitored for a year.
2Treatment groups
Experimental Treatment
Group I: XEN63 Ab InternoExperimental Treatment1 Intervention
Participants will be implanted with XEN63 via ab interno surgical approach in the study eye. Participants will be followed for up to 12 months.
Group II: XEN63 Ab ExternoExperimental Treatment1 Intervention
Participants will be implanted with XEN63 via ab externo surgical approach in the study eye. Participants will be followed for up to 12 months.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Coastal Research Associates - Roswell /ID# 268458Roswell, GA
Arizona Advanced Eye Research Institute /ID# 268363Glendale, AZ
New Vision Eye Center /ID# 269955Vero Beach, FL
Minnesota Eye Consultants - Minneapolis /ID# 272445Minneapolis, MN
More Trial Locations
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Who Is Running the Clinical Trial?
AbbVieLead Sponsor
References
XEN 63 gel stent device in glaucoma surgery: A 5-years follow-up prospective study. [2022]To evaluate the efficacy and safety of the XEN63 Gel Stent in patients with open-angle glaucoma (OAG).
Comparing Medium-Term Clinical Outcomes following XEN® 45 and XEN® 63 Device Implantation. [2022]Label="PURPOSE" NlmCategory="OBJECTIVE">To evaluate medium-term clinical outcomes with XEN® 45 or XEN® 63 Gel Stent (Allergan, Dublin, Ireland) for treatment of primary open angle glaucoma (POAG). Materials and Methods. Retrospective, descriptive, and observational study involving 40 patients implanted with a XEN® 45 Gel Stent and 34 implanted with a XEN® 63 Gel Stent who had undergone POAG surgery and had been followed up and controlled between 12 and 36 months.
Two-year outcomes of minimally invasive XEN Gel Stent implantation in primary open-angle and pseudoexfoliation glaucoma. [2021]Label="PURPOSE" NlmCategory="OBJECTIVE">The aim of this study was to evaluate the efficacy of XEN® Gel Stent implantation in the treatment of primary open-angle glaucoma (POAG) and pseudoexfoliation glaucoma (XFG) regarding the reduction of intraocular pressure (IOP) and number of IOP-lowering medications over 2 years.
[XEN 45® gel stent implantation in glaucoma surgery: Dual-center comparative study between steroid-induced glaucoma and primary open angle glaucoma]. [2022]XEN 45® gel stent is an ab interno aqueous humor drainage device indicated for moderate glaucoma refractory to medical management. Its efficacy has been demonstrated in primary open-angle glaucoma (POAG). However, there are few studies on secondary glaucoma, including steroid-induced glaucoma (CG), defined as optic neuropathy induced by using local or systemic corticosteroids without increased flare.
XEN Gel Stent in the management of primary open-angle glaucoma. [2020]To assess the efficacy and safety of the XEN Gel Stent in patients with primary open-angle glaucoma.
[Efficacy of the XEN gel stent on intraocular pressure lowering in glaucoma patients]. [2021]Objective: To evaluate the efficacy and safety of the XEN gel implant in the treatment of glaucoma. Methods: It was a retrospective case series study. Eight patients (8 eyes) in the First Affiliated Hospital of Fujian Medical University from January 2020 to September 2020 were included, including six males and two females, aged 29 to 74 years. The patients treated with the XEN gel implanting for glaucoma. After detailed ophthalmic examination, all the patients met the surgical indications for the XEN gel implanting. Preoperative and postoperative intraocular pressure (IOP), anterior segment and fundus examination results, medication, and surgical complications were evaluated. Results: There were seven patients with primary open-angle glaucoma and one patient with glaucomatocyclitic syndrome. Five patients had received anti-glaucoma surgeries, and the remaining three patients had not received surgical treatment. All XEN gel stents were implanted successfully. All patients were followed up for 4 to 12 months. The preoperative maximum IOP ranged from 11 to 44 mmHg (median, 28 mmHg, 1 mmHg=0.133 kPa), and the IOP was 10 to 18 mmHg (median, 13 mmHg) at the last follow-up. Two to 4 types of medication were used for glaucoma preoperatively (median, 3), while 0 to 2 types (median, 0) were used at the last follow-up. During the follow-up, 7 cases were completely successful and only one case failed. Intraoperative hemorrhage occurred in two patients, and after effective treatment, the IOP decreased to below 20 mmHg. One patient was found to have an increased IOP with the XEN luminal obstruction, and the XEN drainage tube was recanalized. The IOP was about 10 mmHg at the last follow-up, and no anti-glaucoma drugs were used, but the surgery was assessed as failure by standard. The remaining patients had no other serious complications. Conclusion: This preliminary study shows that the XEN gel drainage may be a safe and effective treatment for patients with glaucoma. (Chin J Ophthalmol, 2021, 57: 679-684).
XEN implant in primary and secondary open-angle glaucoma: A 12-month retrospective study. [2022]The aim of this study was to compare the efficacy and safety of the XEN45 gel stent implant in patients with primary open-angle glaucoma or secondary open-angle glaucoma.
Recanalization of Xen45 gel stent implant occlusion using 10 - 0 nylon suture in refractory glaucoma: a case report. [2023]Xen Gel Stent implant is a new minimally invasive surgical treatment for glaucoma that has been proven effectiveness and safety profile. However, it may also lead to some complications. Xen Gel Stent occlusion is a relatively rare complication reported less frequently and has limited treatment experience. In our case report, we proposed a novel surgical treatment using a 10 - 0 nylon suture to successfully recanalize the occluded Xen45 Gel Stent.
"Culture-positive exogenous endophthalmitis related to XEN45 gel stent implantation". [2022]The XEN45 gel stent implant (Allergen, CA, USA) is one of many micro-invasive surgical options available to glaucomatologists. Our case series describes the presentation, treatment, and possible risk factors of XEN45 gel stent related endophthalmitis.