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Rho-Kinase Inhibitor

Rho-Kinase Inhibitor for Advanced Glaucoma

Phase 2

Waitlist Available

Research Sponsored by New York Glaucoma Research Institute

Eligibility Criteria Checklist

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

Must have

Patients with open-angle glaucoma with prior glaucoma filtering surgery

Be older than 18 years old

Must not have

Inability to perform reliable visual field testing

Patients not able to understand the nature of the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will evaluate the efficacy of AR-12286 in delaying or avoiding the necessity of further surgical intervention in glaucoma patients with failed prior glaucoma filtering surgery and uncontrolled IOP.

Who is the study for?

This trial is for adults over 18 with advanced glaucoma who've had unsuccessful surgery to lower eye pressure and are at risk of more surgery. They must be able to attend treatment for 6 months, have high eye pressure or worsening vision, and not use other eye meds except for specific exceptions.

What is being tested?

The study tests two strengths (0.5% and 0.7%) of a Rho-Kinase Inhibitor eyedrop, AR-12286, on patients with uncontrolled glaucoma after previous surgeries failed. It aims to see if the drops can reduce eye pressure effectively over six months and possibly delay or avoid further surgery.

What are the potential side effects?

Possible side effects may include reactions at the application site like discomfort or redness, potential allergic reactions if sensitive to ingredients in the solution such as benzalkonium chloride, and general ocular irritation.

Eligibility Criteria

Inclusion Criteria

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

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I have open-angle glaucoma and had surgery to lower eye pressure.

Exclusion Criteria

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

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I cannot complete reliable vision field tests.

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I understand what this study is about.

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I have been diagnosed with closed angle glaucoma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Effect of study drug to reduce IOP

Secondary study objectives

IOP Reduction

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: 0.7% Rho-Kinase InhibitorExperimental Treatment1 Intervention

AR-12286 is a novel Rho-kinase inhibitor developed by Aerie Pharmaceuticals, Inc., Bridgewater, NJ. It is a potent Rho-kinase inhibitor with single-digit nanomolar inhibitory activity against Rho-kinase in enzymatic inhibition assays (deLong MA, et al. IOVS 2009; 50: ARVO E-abstract 4058). Mechanism-of action studies in monkeys demonstrate that AR-12286 lowers IOP primarily by increasing aqueous humor outflow through the trabecular meshwork (Wang RF, et al. IOVS 2009; 50:ARVO E-abstract 1465). Rho-kinase AR-12286 is well tolerated and produces clinically and statistically significant ocular hypotensive efficacy in patients with ocular hypertension and glaucoma. It is well tolerated by most of patients and the only side effect was ocular hyperemia in a minority of subjects (Williams, Novack, Van Haarlem, \& Kopczynski, 2011). It is currently in phase II testing.

Group II: 0.5% Rho-Kinase InhibitorExperimental Treatment1 Intervention

0 / 4Eligibility criteria met