XEN45 Gel Stent for Open-Angle Glaucoma

Recruiting at 24 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Disqualifiers: Unhealthy conjunctiva, Excessive bleeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

65 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for using the XEN45 Gel Stent to treat open-angle glaucoma, a common eye condition that can lead to blindness. Researchers aim to determine if placing the stent outside the eye (ab externo approach) is safe and effective. Participants with open-angle glaucoma not controlled by medication, or who have had unsuccessful eye surgeries, might be suitable candidates. During the trial, participants will receive the stent and undergo regular check-ups for a year to monitor their eye health. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

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 prior data suggests that this device is safe for treating open-angle glaucoma?

Research has shown that the XEN45 gel stent is generally safe and effective for treating open-angle glaucoma. In studies where the stent was placed inside the eye, many patients experienced a significant drop in eye pressure. Specifically, after one year, 76.3% of patients had much lower eye pressure, although some required additional surgeries later.

While the XEN45 stent is approved for use inside the eye, this trial tests a new method of placing it outside the eye. Since this trial is in an advanced stage, earlier safety tests have already been completed. Thus, while the new method is still under study, the stent itself is known to be safe. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for glaucoma?

The XEN45 Gel Stent is unique because it uses a minimally invasive approach to treat open-angle glaucoma. Traditional treatments often involve medications or more invasive surgeries to lower eye pressure. However, XEN45 is implanted using an ab externo approach, which means it's placed outside the eye, potentially reducing recovery time and surgical risks. Researchers are excited about its ability to consistently lower intraocular pressure with less trauma to the eye compared to conventional methods. This innovative method could make a significant difference for patients looking for safer and more effective glaucoma management.

What evidence suggests that the XEN45 Gel Stent is effective for open-angle glaucoma when implanted using the ab externo approach?

Research has shown that the XEN45 gel stent effectively treats open-angle glaucoma. Studies have found that the stent safely lowers eye pressure and reduces the need for medications. Over five years, patients experienced a significant drop in eye pressure and used fewer medications. Although the stent has been successful when placed inside the eye, this trial tests a new method of placing it outside the eye to determine if it can provide similar benefits. Overall, the stent has a proven track record of effectively managing glaucoma. ^{1 2 3 6 7}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• XEN45

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.

How Is the Trial Designed?

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

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

XEN45 is already approved in United States, European Union for the following indications:

Approved in United States as XEN Gel Stent for:

• Primary open-angle glaucoma
• Pseudoexfoliative glaucoma
• Pigmentary glaucoma
• Refractory open-angle glaucoma

Approved in European Union as XEN Gel Stent for:

• Open-angle glaucoma unresponsive to maximum tolerated medical therapy

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

Published Research Related to This Trial

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]

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]

The Xen Gel Stent is an effective minimally invasive treatment for glaucoma, but it can occasionally become occluded, as seen in a case where a 16-year-old patient experienced increased intraocular pressure after implantation.

A novel surgical technique using a 10-0 nylon suture to recanalize the occluded stent proved successful, allowing for effective control of intraocular pressure without the need to remove the stent, demonstrating a safe and effective solution for this complication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recanalization of Xen45 gel stent implant occlusion using 10 - 0 nylon suture in refractory glaucoma: a case report. Zhang, Y., Xiang, H., Zhang, Y., et al.[2023]

The XEN45 Gel Stent significantly reduced intraocular pressure (IOP) in East Asian patients with primary open angle glaucoma, lowering it from an average of 21.7 mmHg to 15.0 mmHg after 12 months, while also decreasing the average number of glaucoma medications from 3.4 to 1.3.

While the procedure showed effectiveness with no major complications, 45.9% of patients required additional postoperative interventions, indicating that careful monitoring and potential follow-up treatments may be necessary for optimal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

XEN45 Gel Stent implantation in eyes with primary open angle glaucoma: A study from a single hospital in Taiwan. Chao, YJ., Ko, YC., Chen, MJ., et al.[2023]

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]

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]

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]

The XEN45 gel stent significantly reduced intraocular pressure in patients with primary and secondary open-angle glaucoma, lowering it from an average of 22.3 mmHg to 15.3 mmHg after 12 months, with a success rate of 72.6%.

While the treatment effectively decreased the need for antiglaucoma medications, there were safety concerns, including complications such as implant extrusion and one case of endophthalmitis requiring surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

XEN implant in primary and secondary open-angle glaucoma: A 12-month retrospective study. Ibáñez-Muñoz, A., Soto-Biforcos, VS., Rodríguez-Vicente, L., et al.[2022]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38789132/

Two-year outcomes of Xen 45 gel stent implantation in ... The Xen 45 gel stent implant offers acceptable long-term efficacy for the treatment of open-angle glaucoma. However, there is a significant rate of reoperation ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37725786/

XEN 45 Gel Stent Implantation in Open Angle Glaucoma At 5 years, XEN gel stent implantation was a safe procedure and achieved clinically meaningful IOP and medication reduction.

3. nature.com nature.com/articles/s41433-024-03042-z

Three-year clinical outcome of XEN45 Gel Stent ... showed a decrease in mean number of glaucoma medications from 2.0 ± 1.2 after XEN Gel in patients suffering from primary open angle glaucoma and ...

4. bjo.bmj.com bjo.bmj.com/content/108/12/1672

Two-year outcomes of Xen 45 gel stent implantation in ... The Xen 45 gel stent implant offers acceptable long-term efficacy for the treatment of open-angle glaucoma. However, there is a significant rate of reoperation ...

5. hcp.xengelstent.com hcp.xengelstent.com/clinical-efficacy

Clinical Effectiveness *In the XEN® Gel Stent clinical study, baseline medicated IOP ranged from 20.0 to 33.7 mm Hg.7. XEN® Gel Stent provided consistent efficacy from a range of ...

6. hcp.xengelstent.com hcp.xengelstent.com/

Home Page - XEN® Gel Stent DOCUMENTED XEN® GEL STENT OUTCOMES​​ In the primary analysis at 12 months, 76.3% (95% CI = 65.8, 86.8%) of subjects achieved ≥ 20% mean diurnal IOP reduction on ...

7. bmcophthalmol.biomedcentral.com bmcophthalmol.biomedcentral.com/articles/10.1186/s12886-024-03522-6

Long-term efficacy and safety of XEN-45 gel stent implantation ... The primary outcome measure was surgical success after three years defined as lowering of intraocular pressure (IOP) of ≥ 20%, with target IOP ...