What side effects are associated with this type of intervention?

Common treatments for ocular hypertension, such as prostaglandin analogs, beta-blockers, alpha agonists, carbonic anhydrase inhibitors, and Rho kinase inhibitors, have various side effects. Prostaglandin analogs may cause eye redness, eyelash growth, and iris color changes. Beta-blockers can lead to systemic effects like bradycardia and respiratory issues. Alpha agonists might cause dry mouth and fatigue. Carbonic anhydrase inhibitors can result in a metallic taste and tingling in extremities. Rho kinase inhibitors, similar to AGN-193408 SR, often cause eye redness, corneal verticillata, and conjunctival hemorrhage.

What prior FDA approvals exist?

Several FDA-approved treatments for ocular hypertension focus on lowering intraocular pressure. These include prostaglandin analogs like latanoprost, beta-blockers such as timolol, and carbonic anhydrase inhibitors like dorzolamide. Additionally, combination therapies, such as latanoprost/timolol, have been approved for enhanced efficacy. Sustained-release formulations, similar to AGN-193408 SR, aim to provide consistent IOP reduction over an extended period, improving patient adherence and outcomes.

What other types of research exist?

Promising novel alternatives to AGN-193408 SR for ocular hypertension patients include: 1) Sustained drug delivery systems, which offer prolonged IOP control and improved patient compliance. 2) Prostaglandin DP receptor agonists like AL-6598, which increase uveoscleral outflow. 3) Personalized medicine approaches that tailor treatments based on individual patient profiles. These alternatives are in line with future trends in glaucoma therapy and may provide effective IOP reduction.

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Prostaglandin Analog

AGN-193408 SR for Glaucoma

Phase 1 & 2

Recruiting

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of either OAG [open-angle glaucoma] (ie, primary OAG, pseudoexfoliation glaucoma,pigmentary glaucoma) or OHT (ocular hypertension) in both eyes.

Diagnosis of either OAG [open-angle glaucoma] (ie, primary OAG, pseudoexfoliation glaucoma, pigmentary glaucoma) or OHT (ocular hypertension) in both eyes.

Must not have

Any history of corneal graft, including partial grafts (eg, Descemet's Stripping Endothelial Keratoplasty [DSEK], Descemet's Membrane Endothelial Keratoplasty [DMEK]); or incisional refractive surgery (eg, radial keratotomy), other than astigmatic keratotomy or limbal relaxing incisions in the study eye.

History or evidence of a peripheral iridotomy/iridectomy in the inferior iris in the study eye.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to month 36

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Possible side effects aren't detailed here but may include typical reactions related to ocular medications such as redness, discomfort at the application site, changes in vision, itching or swelling of the eyes. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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

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I plan to use eye drops not allowed by the study.

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I have had complex cataract or lens surgery with complications.

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I expect to need eye surgery during the study.

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I have had swelling in the retina of one or both eyes.

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I have had surgery for glaucoma in at least one eye.

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I have had eye infections caused by herpes viruses.

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I have had a significant eye injury in the past.

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I have a history of narrow angle or closed angle glaucoma in one eye.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to month 36

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to month 36

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to month 36 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline in Hour 0 Intraocular Pressure (IOP) in the Study Eye

Secondary study objectives

Time to Rescue Treatment or Re-Treatment in the Study Eye

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for ocular hypertension aim to lower intraocular pressure (IOP) to prevent damage to the optic nerve and progression to glaucoma. Prostaglandins increase the outflow of aqueous humor from the eye, effectively reducing IOP. Beta-blockers decrease the production of aqueous humor, thereby lowering IOP. Carbonic anhydrase inhibitors also reduce aqueous humor production by inhibiting the enzyme carbonic anhydrase. Alpha agonists work by both decreasing aqueous humor production and increasing its outflow. Sustained-release formulations like AGN-193408 SR are designed to provide a consistent therapeutic effect over a longer period, improving patient compliance and maintaining stable IOP levels. These mechanisms are crucial for managing ocular hypertension and preventing vision loss.

Average versus highest intraocular pressure analyses in glaucoma clinical trials.