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A Study to Assess the Effect of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Patients With Chronic Angle-closure Glaucoma (ROCK - CACG)

Primary Purpose

Chronic Angle-closure Glaucoma

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Rho-Kinase Inhibitor
Sponsored by
New York Glaucoma Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Angle-closure Glaucoma

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients between 50 and 85 years old; of either sex.
  2. Patients with CACG with ≥180⁰ PAS
  3. IOP ≥22 mmHg prior to initiation of treatment in one or both eyes with two measurements taken two hours apart
  4. No previous intraocular surgery except clear cornea phacoemulsification.
  5. Corrected visual acuity in both eyes ≥20/50 in the eligible eye
  6. Not more than 6 diopters spherical equivalent on the study eye
  7. Not more than 3 diopters cylinder equivalent on the study eye
  8. Have given written informed consent, prior to any investigational procedures.
  9. Ability to attend for the 6-month duration of the study

Exclusion Criteria:

  1. Open angle glaucoma
  2. Closed angle glaucoma with <180⁰ PAS
  3. Intraocular pressure >35 mmHg
  4. Severe glaucomatous damage
  5. Known hypersensitivity to any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics.
  6. Previous intraocular surgery except clear cornea phacoemulsification.
  7. Clinically significant ocular disease (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study.
  8. Ocular medication of any kind within 30 days of base-line visit, with the exception of ocular hypotensive medications and/or drops for treatment of dry eye syndrome (which may be used throughout the study).
  9. Any abnormality preventing reliable applanation tonometry of either eye.
  10. Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study.
  11. Changes of systemic medication that could have a substantial effect on IOP anticipated during the study.
  12. Participation in any investigational study within the past 30 days.
  13. Inability to perform reliable VF testing.
  14. Unwilling to sign the consent form approved by the Institutional Review Board (IRB) of the New York Eye and Ear Infirmary.
  15. Self-reported poor compliance to treatment.
  16. Reluctance to return for scheduled follow-up visits.
  17. Patients not able to understand the nature of the study.

Sites / Locations

  • Glaucoma Associates of New York

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

0.5% Rho-Kinase Inhibitor

0.7% Rho-Kinase Inhibitor

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Long Lasting effect of study drug to reduce IOP
To evaluate the ocular hypotensive efficacy of Rho kinase Inhibitor (AR-12286 0.5% and 0.7%) ophthalmic solutions in patients diagnosed with CACG treated for 6 months.

Secondary Outcome Measures

Secondary Outcome
To determine if AR-12286 can be used as directed therapy for CACG, reducing or eliminating the structural blockage of the trabecular meshwork that leads to development of elevated IOP.

Full Information

First Posted
May 23, 2014
Last Updated
April 23, 2015
Sponsor
New York Glaucoma Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02152774
Brief Title
A Study to Assess the Effect of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Patients With Chronic Angle-closure Glaucoma
Acronym
ROCK - CACG
Official Title
A Prospective Study to Assess the Hypotensive Efficacy of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Patients With Chronic Angle-closure Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York Glaucoma Research Institute

4. Oversight

5. Study Description

Brief Summary
To evaluate the ocular hypotensive efficacy of Rho kinase Inhibitor (AR-12286 0.5% and 0.7%) ophthalmic solutions in patients diagnosed with chronic angle-closure glaucoma treated for 6 months. Secondary Outcome Secondary objectives are: To evaluate the early effect of Rho kinase Inhibitor (AR-12286) in reducing intraocular pressure (IOP). To evaluate the long term effect of the drug on IOP. To determine if AR-12286 can be used as directed therapy for CACG, reducing or eliminating the structural blockage of the trabecular meshwork that leads to development of elevated IOP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Angle-closure Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
0.5% Rho-Kinase Inhibitor
Arm Type
Experimental
Arm Description
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.
Arm Title
0.7% Rho-Kinase Inhibitor
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Rho-Kinase Inhibitor
Primary Outcome Measure Information:
Title
Long Lasting effect of study drug to reduce IOP
Description
To evaluate the ocular hypotensive efficacy of Rho kinase Inhibitor (AR-12286 0.5% and 0.7%) ophthalmic solutions in patients diagnosed with CACG treated for 6 months.
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Secondary Outcome
Description
To determine if AR-12286 can be used as directed therapy for CACG, reducing or eliminating the structural blockage of the trabecular meshwork that leads to development of elevated IOP.
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients between 50 and 85 years old; of either sex. Patients with CACG with ≥180⁰ PAS IOP ≥22 mmHg prior to initiation of treatment in one or both eyes with two measurements taken two hours apart No previous intraocular surgery except clear cornea phacoemulsification. Corrected visual acuity in both eyes ≥20/50 in the eligible eye Not more than 6 diopters spherical equivalent on the study eye Not more than 3 diopters cylinder equivalent on the study eye Have given written informed consent, prior to any investigational procedures. Ability to attend for the 6-month duration of the study Exclusion Criteria: Open angle glaucoma Closed angle glaucoma with <180⁰ PAS Intraocular pressure >35 mmHg Severe glaucomatous damage Known hypersensitivity to any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics. Previous intraocular surgery except clear cornea phacoemulsification. Clinically significant ocular disease (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study. Ocular medication of any kind within 30 days of base-line visit, with the exception of ocular hypotensive medications and/or drops for treatment of dry eye syndrome (which may be used throughout the study). Any abnormality preventing reliable applanation tonometry of either eye. Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study. Changes of systemic medication that could have a substantial effect on IOP anticipated during the study. Participation in any investigational study within the past 30 days. Inability to perform reliable VF 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.
Facility Information:
Facility Name
Glaucoma Associates of New York
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Study to Assess the Effect of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Patients With Chronic Angle-closure Glaucoma

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