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Enzyme Inhibitor

Rho-Kinase Inhibitor for Glaucoma (ROCK - CACG Trial)

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

No previous intraocular surgery except clear cornea phacoemulsification

Patients with CACG with ≥180⁰ PAS

Must not have

Open angle glaucoma

Closed angle glaucoma with <180⁰ PAS

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a Rho kinase inhibitor as a potential treatment for chronic angle-closure glaucoma. The objectives are to evaluate the efficacy of the drug in reducing intraocular pressure, both in the short and long term, and to determine if the drug can be used to reduce or eliminate the structural blockage that leads to the development of elevated intraocular pressure in chronic angle-closure glaucoma.

Who is the study for?

This trial is for people aged 50-85 with chronic angle-closure glaucoma, vision of at least 20/50, and eye pressure ≥22 mmHg. They must be able to attend a 6-month study and have not had certain eye surgeries or systemic diseases that could affect the study.

What is being tested?

The trial tests Rho-Kinase Inhibitor (AR-12286) ophthalmic solutions at two different strengths (0.5% and 0.7%) to see if they lower eye pressure in patients with chronic angle-closure glaucoma over six months.

What are the potential side effects?

Possible side effects may include mild discomfort in the eyes, potential allergic reactions to ingredients like benzalkonium chloride, or other unspecified effects related to lowering intraocular pressure.

Eligibility Criteria

Inclusion Criteria

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

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I have only had cataract surgery on my eye.

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I have advanced angle-closure glaucoma.

Exclusion Criteria

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

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I have been diagnosed with open angle glaucoma.

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I have a type of glaucoma with less than half my eye's angle blocked.

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I have severe damage from glaucoma.

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I do not have serious eye conditions that could affect the study.

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I cannot perform vision field tests accurately.

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I understand what this study involves.

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I have had eye surgery, but only cataract removal with a clear cornea method.

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

Long Lasting effect of study drug to reduce IOP

Secondary study objectives

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, potent Rho-kinase inhibitor developed by Aerie Pharmaceuticals, Inc., Bridgewater, NJ. It has single-digit nanomolar inhibitory activity against Rho-kinase in enzymatic inhibition assays. Mechanism-of action studies in monkeys demonstrate that AR-12286 lowers IOP primarily by increasing aqueous humor outflow through the trabecular meshwork 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 patients and the only side effect was ocular hyperemia in a minority of subjects. It is currently in phase II testing.

Group II: 0.5% Rho-Kinase InhibitorExperimental Treatment1 Intervention

0 / 9Eligibility criteria met