XEN45 Gel Stent for Open-Angle Glaucoma

Recruiting in Palo Alto (17 mi)

+24 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: AbbVie

Disqualifiers: Unhealthy conjunctiva, Excessive bleeding, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

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 externo approach. Adverse events and intraocular pressure will be assessed. XEN45 is an approved device for the treatment of glaucoma implanted using the ab interno approach (inside the eye). XEN45 implanted using the ab externo approach (outside the eye) is being studied in this study. Approximately 65 participants aged 45 years or older with open-angle glaucoma will be enrolled in this study at approximately 22 sites in the United States. All participants will receive XEN45 implanted using 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 protocol does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the XEN45 Gel Stent treatment for open-angle glaucoma?

Research shows that the XEN45 Gel Stent, a small device used in eye surgery, is effective in treating open-angle glaucoma by helping to lower eye pressure. Studies have found it to be promising in terms of safety and effectiveness, even when used with or without cataract surgery. ^{1 2 3 4 5}

Is the XEN45 Gel Stent safe for humans?

The XEN45 Gel Stent has been studied for safety in treating open-angle glaucoma, showing a generally safe profile, though some complications like stent occlusion can occur. ^{4 6 7 8 9}

How is the XEN45 Gel Stent treatment different from other treatments for open-angle glaucoma?

The XEN45 Gel Stent is unique because it is a minimally invasive device that helps drain fluid from the eye to lower pressure, which is different from traditional surgeries or medications. It is implanted through a small incision and works by creating a new pathway for fluid to leave the eye, reducing the risk of complications compared to more invasive procedures. ^{1 2 3 4 10}

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

This trial is for people aged 45 or older with open-angle glaucoma who've had unsuccessful previous glaucoma surgeries, such as filtering surgery or tube shunt. It's also for those with conditions like conjunctival scarring or uveitis where standard surgery might fail. Participants should not have eye anatomy that limits the view of certain areas, excessive bleeding during operation, scarred conjunctiva in the target area, or other complications affecting stent placement.

Inclusion Criteria

I have been diagnosed with neovascular glaucoma.

Study eye that meet at least one of the following criteria:

I have a condition that makes standard glaucoma surgery likely to fail.

Exclusion Criteria

Other surgical complication that in the opinion of the investigator could impede proper placement of the Gel Stent.

My eye's outer layer is healthy and moves freely, with no scars or past surgeries.

I experienced heavy bleeding in my eye during surgery, affecting my vision.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive XEN45 implanted using the ab externo approach on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment through regular visits and medical assessments

12 months

Regular visits (in-person)

Treatment Details

Interventions

• XEN45 (Device)

Trial Overview The study tests the safety and effectiveness of a XEN45 Glaucoma Gel Stent implanted using an ab externo approach (outside the eye). All participants will receive this treatment on Day 1 and be monitored over 12 months through regular hospital visits to assess changes in intraocular pressure and overall impact on their glaucoma condition.

Participant Groups

Group I: XEN45 (Glaucoma Gel Stent) Experimental Treatment 1 Intervention

Participants will receive XEN45 implanted using an ab externo approach on Day 1.

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Findings from Research

The XEN45 Gel Stent is generally safe for treating open angle glaucoma, with a meta-analysis of 33 studies showing that 20% of patients experienced numerical hypotony as the most common complication.

Despite its safety, over one-third of patients (35%) required at least one post-operative bleb needling procedure, indicating a need for further high-quality studies to better understand the long-term outcomes and complications associated with this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications and post-operative interventions in XEN45 gel stent implantation in the treatment of open angle glaucoma-a systematic review and meta-analysis. Betzler, BK., Lim, SY., Lim, BA., et al.[2023]

In a study of 148 glaucoma patients, the XEN45 gel stent implantation led to significant reductions in intraocular pressure (IOP) after 12 months, achieving qualified success rates of 76% in patients without prior interventions and 72% in those with prior interventions.

Both groups experienced a substantial decrease in the number of hypotensive medications needed, from an average of 3.6 to 0.3 in the no prior intervention group and from 3.0 to 0.3 in the prior intervention group, indicating the treatment's effectiveness regardless of previous glaucoma surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Minimally Invasive XEN45 Gel Stent Implantation in Glaucoma Patients Without and With Prior Interventional Therapies. Hengerer, FH., Auffarth, G., Conrad-Hengerer, I.[2020]

XEN45 gel stent implantation significantly lowers intraocular pressure (IOP) in glaucoma patients, with results showing lower IOP at all postoperative visits compared to preoperative levels, indicating its efficacy as a treatment.

Despite some patients experiencing elevated IOP after 12 months, these increases were manageable with medication, and no additional surgeries were required, highlighting the safety of this minimally invasive procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An innovation in glaucoma surgery: XEN45 gel stent implantation. Ozal, SA., Kaplaner, O., Basar, BB., et al.[2018]

The cross-linked gel stent (XEN45) significantly reduced intraocular pressure (IOP) and the number of medications needed for glaucoma patients over a 12-month period, with mean IOP dropping from 23.9 mmHg to 15.5 mmHg.

Both the Solo Group (115 patients) and Combo Group (56 patients) showed similar efficacy, indicating that the stent can be safely used alone or in combination with cataract surgery to manage open-angle glaucoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

European study of the efficacy of a cross-linked gel stent for the treatment of glaucoma. Fea, AM., Bron, AM., Economou, MA., et al.[2021]

In a study of 85 patients with open-angle glaucoma, the XEN45 gel stent significantly reduced intraocular pressure (IOP) from an average of 20.6 mmHg to 13.7 mmHg one year after implantation, indicating its efficacy in managing glaucoma.

The number of preoperative glaucoma medications influenced postoperative outcomes, with higher pre-surgery medication correlating with increased IOP and medication use after surgery, while the procedure demonstrated a strong safety profile with no sight-threatening adverse events reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glaucoma medical treatment as a predictor of XEN45 subconjunctival gel implant hypotensive efficacy. Méndez-Hernández, C., Palomino-Bautista, C., Torres-Imaz, R., et al.[2023]

The XEN Gel Stent significantly reduced intraocular pressure by 18% over one year in patients with primary open-angle glaucoma, while also decreasing the average number of anti-glaucoma medications needed from 3.2 to 1.6.

Despite some transient complications like hypotony in 90% of eyes, the overall safety profile was favorable, and the stent helped stabilize retinal function as indicated by consistent pattern electroretinogram (PERG) results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

XEN Gel Stent in the management of primary open-angle glaucoma. Post, M., Lubiński, W., Śliwiak, D., et al.[2020]

The XEN 45® gel stent demonstrated a 100% success rate in reducing intraocular pressure (IOP) in patients with steroid-induced glaucoma, compared to a 42.6% success rate in those with primary open-angle glaucoma (POAG).

Patients with steroid-induced glaucoma experienced a significant IOP reduction of 69.1% postoperatively, highlighting the stent's efficacy in this specific type of glaucoma, which is less studied than POAG.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[XEN 45® gel stent implantation in glaucoma surgery: Dual-center comparative study between steroid-induced glaucoma and primary open angle glaucoma]. Cornée, C., Orignac, I., Wargny, M., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Complications and post-operative interventions in XEN45 gel stent implantation in the treatment of open angle glaucoma-a systematic review and meta-analysis. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Comparison of Minimally Invasive XEN45 Gel Stent Implantation in Glaucoma Patients Without and With Prior Interventional Therapies. [2020]

3. Brazil pubmed.ncbi.nlm.nih.gov

An innovation in glaucoma surgery: XEN45 gel stent implantation. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

European study of the efficacy of a cross-linked gel stent for the treatment of glaucoma. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Glaucoma medical treatment as a predictor of XEN45 subconjunctival gel implant hypotensive efficacy. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

XEN Gel Stent in the management of primary open-angle glaucoma. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Recanalization of Xen45 gel stent implant occlusion using 10 - 0 nylon suture in refractory glaucoma: a case report. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

XEN implant in primary and secondary open-angle glaucoma: A 12-month retrospective study. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

XEN45 Gel Stent implantation in eyes with primary open angle glaucoma: A study from a single hospital in Taiwan. [2023]

10. France pubmed.ncbi.nlm.nih.gov

[XEN 45® gel stent implantation in glaucoma surgery: Dual-center comparative study between steroid-induced glaucoma and primary open angle glaucoma]. [2022]