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

• Sponsor: New York Glaucoma Research Institute (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02174991
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arms: 2

Study Details

Study Description

Brief Summary

1. 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.

2. To evaluate the efficacy of AR-12286 in enabling treated patients to delay or avoid the necessity of surgical intervention.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Drug: Rho-Kinase Inhibitor (AR-12286)	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: A Prospective 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
• Study Start Date: Jun 1, 2014
• Actual Primary Completion Date: Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 0.5% Rho-Kinase Inhibitor 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)
Experimental: 0.7% Rho-Kinase Inhibitor 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)

Outcome Measures

Primary Outcome Measures

1. IOP Reduction [6 Months]

   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

Secondary Outcome Measures

1. Tolerance and Lasting IOP Effect [6 Months]

   To evaluate the ocular hypotensive safety (tolerance) of Rho-Kinase Inhibitor (AR-12286 0.5% and 0.7%) ophthalmic solution in patients who are avoiding surgical intervention and the long last effect of IOP reduction.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients with open-angle glaucoma.

2. IOP above the target range or visual field progression with use of maximum standard drug therapy.

3. Have given written informed consent, prior to any investigational procedures.

4. Ability to attend for the 6-month duration of treatment.

Exclusion Criteria:

1. Angle-closure glaucoma

2. Eyes having had previous incisional glaucoma surgery

3. Known hypersensitivity to any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics.

4. 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).

5. Any abnormality preventing reliable applanation tonometry of the treated eye.

6. Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study.

7. Participation in any investigational study within the past 30 days.

8. Inability to perform reliable visual field testing.

9. Unwilling to sign the consent form approved by the Institutional Review Board (IRB) of the New York Eye and Ear Infirmary.

10. Self-reported poor compliance to treatment.

11. Reluctance to return for scheduled follow-up visits.

12. Patients not able to understand the nature of the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Glaucoma Associates of New York	New York	New York	United States	10003

Sponsors and Collaborators

• New York Glaucoma Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jessica Jasien, Co-Investigator, New York Glaucoma Research Institute
• ClinicalTrials.gov Identifier: NCT02174991
• Other Study ID Numbers: 14.15
• First Posted: Jun 26, 2014
• Last Update Posted: Apr 24, 2015
• Last Verified: Apr 1, 2015

• Additional relevant MeSH terms: Glaucoma

Study Results

No Results Posted as of Apr 24, 2015