Back to resultsA Study to Assess the Effect of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Patients With Uncontrolled Advanced Glaucoma With Prior Failed Trabeculectomy or Tube Shunt
Primary Purpose
Advanced Glaucoma
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Rho-Kinase Inhibitor
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Glaucoma
Eligibility Criteria
Inclusion Criteria:
- Patients older than 18 years of either sex.
- Patients with open-angle glaucoma with prior glaucoma filtering surgery.
- IOP above the target range or visual field progression.
- Have given written informed consent, prior to any investigational procedures.
- Ability to attend for the 6-month duration of treatment.
Exclusion Criteria:
- Closed angle glaucoma (primary or secondary).
- 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.
Sites / Locations
- Glaucoma Associates of New York
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
0.7% Rho-Kinase Inhibitor
0.5% Rho-Kinase Inhibitor
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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 with uncontrolled Advanced Glaucoma with Prior Failed Trabeculectomy or Tube Shunt. The long lasting effect of the AR-12286 drug is hoped to increase aqueous outflow and clear the trabecular meshwork of material and reduce IOP.
Secondary Outcome Measures
IOP Reduction
To determine if AR-12286 can be used as directed therapy for Advanced Glaucoma with Prior Failed Trabeculectomy or Tube Shunt to avoid additional surgical intervention.
Full Information
NCT ID
NCT02173223
First Posted
June 17, 2014
Last Updated
April 23, 2015
Sponsor
New York Glaucoma Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02173223
Brief Title
A Study to Assess the Effect of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Patients With Uncontrolled Advanced Glaucoma With Prior Failed Trabeculectomy or Tube Shunt
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 Uncontrolled Advanced Glaucoma With Prior Failed Trabeculectomy or Tube Shunt
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 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
A. To evaluate the ocular hypotensive efficacy of the rho-kinase Inhibitor (AR-12286 0.5% and 0.7%) ophthalmic solutions in glaucoma patients with failed prior glaucoma filtering surgery and uncontrolled IOP who are facing further 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 further surgical intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced 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
0.7% Rho-Kinase Inhibitor
Arm Type
Experimental
Arm Description
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.
Arm Title
0.5% Rho-Kinase Inhibitor
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Rho-Kinase Inhibitor
Primary Outcome Measure Information:
Title
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 with uncontrolled Advanced Glaucoma with Prior Failed Trabeculectomy or Tube Shunt. The long lasting effect of the AR-12286 drug is hoped to increase aqueous outflow and clear the trabecular meshwork of material and reduce IOP.
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
IOP Reduction
Description
To determine if AR-12286 can be used as directed therapy for Advanced Glaucoma with Prior Failed Trabeculectomy or Tube Shunt to avoid additional surgical intervention.
Time Frame
6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients older than 18 years of either sex.
Patients with open-angle glaucoma with prior glaucoma filtering surgery.
IOP above the target range or visual field progression.
Have given written informed consent, prior to any investigational procedures.
Ability to attend for the 6-month duration of treatment.
Exclusion Criteria:
Closed angle glaucoma (primary or secondary).
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.
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 Uncontrolled Advanced Glaucoma With Prior Failed Trabeculectomy or Tube Shunt
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