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AGN-193408 SR for Glaucoma

Recruiting in Palo Alto (17 mi)

+55 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: AbbVie

Must not be taking: Corticosteroids

Disqualifiers: Ocular trauma, Herpetic ocular diseases, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called AGN-193408 SR to see if it can safely lower eye pressure in people with open-angle glaucoma or ocular hypertension.

Do I need to stop my current medications for the trial?

Participants must stop their current intraocular pressure (IOP) treatments as required by the study, but the protocol does not specify other medications. It's best to discuss your specific medications with the study team.

How is the AGN-193408 SR treatment for glaucoma different from other treatments?

The AGN-193408 SR is a sustained-release implant, which means it gradually releases medication over time, potentially reducing the need for frequent dosing compared to traditional eye drops or other implants. This unique delivery method may offer more consistent control of intraocular pressure (pressure inside the eye) with fewer applications.¹ ² ³ ⁴ ⁵

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

This trial is for people with open-angle glaucoma or ocular hypertension in both eyes. Participants must be willing to stop their current eye pressure treatments for the study without risk, as judged by the investigator. They can't join if they've had certain eye procedures recently, use other eye meds, have allergies to study materials, are in another drug/device study, or have a history of specific eye conditions.

Inclusion Criteria

I have been diagnosed with glaucoma or high eye pressure in both eyes.

Participant is willing to withhold his/her IOP (Intraocular Pressure) treatments according to the study requirements, and in the opinion of the investigator, can do so without significant risk.

Exclusion Criteria

I have had corneal graft surgery or specific eye surgeries other than for astigmatism.

I have had a specific eye surgery in the lower part of my iris.

I am not allergic to any study drugs, their components, or related materials.

See 16 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of AGN-193408 SR and daily vehicle eye drops or Lumigan in the study eye

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

Regular visits as per study protocol

Treatment Details

Interventions

AGN-193408 SR (Prostaglandin Analog)

Trial OverviewThe trial is testing AGN-193408 SR's safety and effectiveness compared to sham administration (placebo), Lumigan Vehicle (inactive form), and Lumigan (active treatment). It starts with dose escalation then moves into randomized groups where participants don't know which treatment they're getting.

Participant Groups

6Treatment groups

Experimental Treatment

Group I: Cohort 3 - Dose BExperimental Treatment4 Interventions

AGN-193408 SR Dose B (single dose on Day 1) + vehicle eye drops (once daily in the evening starting on Day 1) administered in the study eye. Lumigan (once daily in the evening starting on Day 1) + Sham AGN-193408 SR (single administration on Day 1) administered in the non-study eye.

Group II: Cohort 3 - Dose AExperimental Treatment4 Interventions

AGN-193408 SR Dose A (single dose on Day 1) + vehicle eye drops (once daily in the evening starting on Day 1) administered in the study eye. Lumigan (once daily in the evening starting on Day 1) + Sham AGN-193408 SR (single administration on Day 1) administered in the non-study eye.

Group III: Cohort 2 - Dose BExperimental Treatment4 Interventions

Group IV: Cohort 2 - Dose AExperimental Treatment4 Interventions

Group V: Cohort 1 -Dose AExperimental Treatment2 Interventions

Single dose of AGN-193408 SR Dose A administered in the study eye on Day 1. One drop of Lumigan 0.01% administered in the non-study eye once daily every evening starting on Day 1.

Group VI: Cohort 1 - Dose BExperimental Treatment2 Interventions

Single dose of AGN-193408 SR Dose B administered in the study eye on Day 1. One drop of Lumigan 0.01% administered in the non-study eye once daily every evening starting on Day 1.

Find a Clinic Near You

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

Findings from Research

The XEN gel stent implantation significantly reduced intraocular pressure (IOP) in patients with open-angle glaucoma who had previously undergone filtering surgeries, achieving a 49.5% reduction in IOP over 18 months.

The procedure demonstrated high safety, with no intraoperative or postoperative complications reported, and 70% of eyes maintained controlled IOP without the need for anti-glaucomatous medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

XEN Gel Stent Implantation in Eyes With Previous Glaucoma Filtering Surgeries: A Case Series.Vieira, R., Leite, J., Figueiredo, A., et al.[2023]

Baerveldt glaucoma implants significantly reduced intraocular pressure (IOP) from an average of 36.5 mmHg preoperatively to 15.3 mmHg postoperatively in a study of 124 Asian patients over an average follow-up of 33.4 months.

The implants demonstrated a satisfactory success rate, with 54% of eyes achieving complete success, while complications occurred in 34.7% of cases, indicating that while effective, some patients may require further surgical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermediate-term outcome of Baerveldt glaucoma implants in Asian eyes.Seah, SK., Gazzard, G., Aung, T.[2022]