A Compassionate Case Study to Assess the Hypotensive Efficacy of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Glaucoma Patients With Uncontrolled Intraocular Pressure to Avoid Surgical Intervention

NCT02174991 | Unknown Phase 2

• 1 other identifier: 14.15
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

A. To evaluate the ocular hypotensive efficacy of the rho-kinase Inhibitor (AR-12286 0.5% and 0.7%) ophthalmic solutions in open-angle glaucoma patients with uncontrolled IOP who are facing surgical intervention. Patients will be treated for 6 months in this initial trial. B. To evaluate the efficacy of AR-12286 in enabling treated patients to delay or avoid the necessity of surgical intervention.

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

• IOP Reduction

  Avoid surgical intervention of glaucoma treatment with use of AR-12286; long lasting effect of study drug to reduce IOP by increase of aqueous outflow

  6 Months

Secondary Outcomes (1)

• Tolerance and Lasting IOP Effect

  6 Months

Study Arms (2)

0.5% Rho-Kinase Inhibitor

EXPERIMENTAL

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.

Drug: Rho-Kinase Inhibitor (AR-12286)

0.7% Rho-Kinase Inhibitor

EXPERIMENTAL

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.

Drug: Rho-Kinase Inhibitor (AR-12286)

Interventions

Rho-Kinase Inhibitor (AR-12286) DRUG

0.5% Rho-Kinase Inhibitor; 0.7% Rho-Kinase Inhibitor

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with open-angle glaucoma.
• IOP above the target range or visual field progression with use of maximum standard drug therapy.
• Have given written informed consent, prior to any investigational procedures.
• Ability to attend for the 6-month duration of treatment.

You may not qualify if:

• Angle-closure glaucoma
• Eyes having had previous incisional glaucoma surgery
• Known hypersensitivity to any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics.
• Ocular medication of any kind within 30 days of base-line visit, with the exception of ocular hypotensive medications and/or lubricating drops for dry eye (which may be used throughout the study).
• Any abnormality preventing reliable applanation tonometry of the treated eye.
• Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study.
• Participation in any investigational study within the past 30 days.
• Inability to perform reliable visual field testing.
• Unwilling to sign the consent form approved by the Institutional Review Board (IRB) of the New York Eye and Ear Infirmary.
• Self-reported poor compliance to treatment.
• Reluctance to return for scheduled follow-up visits.
• Patients not able to understand the nature of the study.

Sponsors & Collaborators

• New York Glaucoma Research Institute: lead

Study Sites (1)

Glaucoma Associates of New York

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Glaucoma

Interventions

AR-12286

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Investigator

Study Record Dates

• First Submitted: June 17, 2014
• First Posted: June 26, 2014
• Study Start: June 1, 2014
• Primary Completion: February 1, 2015
• Last Updated: April 24, 2015

Record last verified: 2015-04

Locations

US (1)