Apply to Trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

96 Participants Needed

AGN-193408 SR for Glaucoma

Recruiting at 57 trial locations

Overseen ByABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: AbbVie

Must not be taking: Corticosteroids

Disqualifiers: Ocular trauma, Herpetic ocular diseases, others

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

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

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

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

Ahmed glaucoma valve (AGV) implantation was effective in treating refractory glaucoma in Asian patients, with a success rate of 74.5% and significant reductions in intraocular pressure post-surgery.

The procedure had a low complication rate, with hyphaemia being the most common issue (12.77%), and no serious complications leading to loss of vision, making AGV a safe option for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermediate outcomes of Ahmed glaucoma valve surgery in Asian patients with intractable glaucoma.Tai, MC., Cheng, JH., Chen, JT., et al.[2022]

The Baerveldt 250-mm2 Glaucoma Implant significantly reduced intraocular pressure (IOP) from a mean of 36.3 mmHg preoperatively to 15.8 mmHg postoperatively over an average follow-up of 22.8 months, indicating its efficacy in managing glaucoma.

Success rates for the implant were high, with 79% of patients maintaining target IOP levels without further surgery or severe complications at 24 months, demonstrating its reliability as a treatment option for adult refractory glaucoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical experience with the Baerveldt 250-mm2 Glaucoma Implant.WuDunn, D., Phan, AD., Cantor, LB., et al.[2006]

The 350-mm2 Baerveldt glaucoma implant demonstrated a higher overall success rate of 87% in controlling intraocular pressure (IOP) compared to 70% for the 500-mm2 implant over an average follow-up of 37 months.

Both implants showed similar rates of visual acuity improvement and complications, indicating that while the 350-mm2 implant is more effective for IOP control, both options are comparably safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized clinical trial of the 350-mm2 versus the 500-mm2 Baerveldt implant: longer term results: is bigger better?Britt, MT., LaBree, LD., Lloyd, MA., et al.[2022]