Gel Stent for Glaucoma

Recruiting at 11 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Must be taking: IOP-lowering medications

Disqualifiers: Angle-closure glaucoma, Secondary open-angle glaucoma, 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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

130 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{1 5 6 7 8}

How 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. ^{1 2 5 8 9}

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility 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.

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.

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)

Treatment Details

Interventions

• XEN63 Glaucoma Treatment System

Trial Overview 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.

Participant Groups

Group I: XEN63 Ab Interno Experimental Treatment 1 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 Externo Experimental Treatment 1 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.

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 XEN63 Gel Stent significantly reduced intraocular pressure (IOP) in patients with open-angle glaucoma, with 81.8% of treated eyes achieving an IOP of 18 mm Hg or lower, and 54.6% experiencing a reduction of 20% or more.

The procedure also decreased the need for ocular hypotensive medications, with no serious treatment-related adverse events reported, indicating a favorable safety profile for the XEN63 Gel Stent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

XEN 63 gel stent device in glaucoma surgery: A 5-years follow-up prospective study. Lavin-Dapena, C., Cordero-Ros, R., D'Anna, O., et al.[2022]

Both the XEN® 45 and XEN® 63 Gel Stents significantly reduced intraocular pressure (IOP) in patients with primary open angle glaucoma (POAG) over a follow-up period of 1 to 3 years, indicating their efficacy as treatment options.

The majority of procedures (over 90%) were performed without significant complications, suggesting that the implantation of these gel stents is a safe approach for managing POAG.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing Medium-Term Clinical Outcomes following XEN® 45 and XEN® 63 Device Implantation. Fernández-García, A., Zhou, Y., García-Alonso, M., et al.[2022]

The XEN® Gel Stent implantation significantly reduced intraocular pressure (IOP) in patients with primary open-angle glaucoma and pseudoexfoliation glaucoma, achieving an average IOP of 14.6 mmHg at 12 months and 14.8 mmHg at 24 months post-surgery, which is a reduction of 31% and 29% from baseline, respectively.

Patients also experienced a significant decrease in the number of IOP-lowering medications needed, dropping from an average of 2.7 medications before surgery to 1.0 at both 12 and 24 months after surgery, indicating the stent's efficacy in managing glaucoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-year outcomes of minimally invasive XEN Gel Stent implantation in primary open-angle and pseudoexfoliation glaucoma. Rauchegger, T., Angermann, R., Willeit, P., et al.[2021]

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]

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 gel implant was successfully used in 8 patients with glaucoma, resulting in a significant reduction in intraocular pressure (IOP) from a median of 28 mmHg preoperatively to 13 mmHg at the last follow-up, demonstrating its efficacy in managing glaucoma.

The procedure was generally safe, with 7 out of 8 patients achieving successful outcomes and only minor complications reported, such as intraoperative hemorrhage and one case of luminal obstruction, indicating that the XEN gel implant is a promising treatment option for glaucoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficacy of the XEN gel stent on intraocular pressure lowering in glaucoma patients]. Yao, YH., Ye, Q., Wang, XH., et al.[2021]

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 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 implant can lead to rare but serious complications like endophthalmitis, as seen in two patients who developed this condition months after surgery, highlighting the need for careful monitoring post-implantation.

Identified risk factors for endophthalmitis include multiple post-operative procedures, bleb exposure, and the use of antifibrotics, suggesting that individualized treatment plans are essential to minimize infection risks while managing intraocular pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Culture-positive exogenous endophthalmitis related to XEN45 gel stent implantation". Ng, AW., Yip, VC., Ang, BC., et al.[2022]

References

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

XEN 63 gel stent device in glaucoma surgery: A 5-years follow-up prospective study. [2022]

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

Comparing Medium-Term Clinical Outcomes following XEN® 45 and XEN® 63 Device Implantation. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Two-year outcomes of minimally invasive XEN Gel Stent implantation in primary open-angle and pseudoexfoliation glaucoma. [2021]

4. 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]

5. Netherlands pubmed.ncbi.nlm.nih.gov

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

6. China pubmed.ncbi.nlm.nih.gov

[Efficacy of the XEN gel stent on intraocular pressure lowering in glaucoma patients]. [2021]

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

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

8. 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]

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

"Culture-positive exogenous endophthalmitis related to XEN45 gel stent implantation". [2022]