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NCT05411198RECRUITINGIRB Ready

Study to Assess Change in Disease Activity and Adverse Events of Ab Externo Approach for Glaucoma Gel Stent (XEN45) Implantation In Participants Aged 45 Years or Older With Open-Angle Glaucoma

Sponsored by AbbVie

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...
๐Ÿ“Š
1 of 65 participants interested
2% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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.

Who Can Participate

Inclusion Criteria

Glaucoma in the study eye. 1. Study eye diagnosed with open-angle glaucoma uncontrolled by medical therapy 2. Study eye that meet at least one of the following criteria:
Failed one or more incisional intraocular glaucoma surgeries (e.g., glaucoma filtering surgery or tube shunt) (a minimum of approximately 15 subjects will be enrolled)
Failed one or more cilioablative procedures (e.g., cryotherapy, cyclodiode therapy)
Have neovascular glaucoma
Have any other condition (e.g., conjunctival scarring, uveitis) in which a conventional incisional glaucoma surgery like trabeculectomy would be more likely to fail than for a person with uncomplicated primary open-angle glaucoma (OAG). Note: To allow for a subgroup of participants who only have OAG uncontrolled by medical therapy (non-refractory glaucoma), a maximum of 10 participants who meet only criterion a (and not b) will be enrolled.

Exclusion Criteria

A lack of health

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

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Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

65 participants

โšง

Gender

ALL

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Sponsor

AbbVie

Study Locations

Choose your preferred location or select flexible during enrollment

Unknown

Fayetteville

Arkansas

Location available
View Fayetteville location page
Unknown

Pasadena

California

Location available
View Pasadena location page
Unknown

Ventura

California

Location available
View Ventura location page
Unknown

Jacksonville

Florida

Location available
View Jacksonville location page
Unknown

Sarasota

Florida

Location available
View Sarasota location page
Unknown

Vero Beach

Florida

Location available
View Vero Beach location page
Unknown

Atlanta

Georgia

Location available
View Atlanta location page
Unknown

Overland Park

Kansas

Location available
View Overland Park location page
Unknown

Bethesda

Maryland

Location available
View Bethesda location page

๐Ÿ“ And 14 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Looking for Open-Angle Glaucoma Treatment in Fayetteville?

Join others in Arkansas exploring innovative treatment options through clinical research

Open-Angle Glaucoma Treatment Options in Fayetteville, Arkansas

If you're searching for Open-Angle Glaucoma treatment in Fayetteville, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Fayetteville, Pasadena, Ventura and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Open-Angle Glaucoma. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Arkansas
Now Enrolling
Up to 65 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Open-Angle Glaucoma?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Open-Angle Glaucoma

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Open-Angle Glaucoma Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05411198. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.