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Trial record 37 of 1614 for:    glaucoma

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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ClinicalTrials.gov Identifier: NCT02173223
Recruitment Status : Unknown
Verified April 2015 by Jessica Jasien, New York Glaucoma Research Institute.
Recruitment status was:  Active, not recruiting
First Posted : June 24, 2014
Last Update Posted : April 24, 2015
Sponsor:
Information provided by (Responsible Party):
Jessica Jasien, New York Glaucoma Research Institute

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.


Condition or disease Intervention/treatment Phase
Advanced Glaucoma Drug: Rho-Kinase Inhibitor Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : June 2014
Actual Primary Completion Date : February 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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



Primary Outcome Measures :
  1. Effect of study drug to reduce IOP [ Time Frame: 6 Months ]
    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 :
  1. IOP Reduction [ Time Frame: 6 Months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients older than 18 years of either sex.
  2. Patients with open-angle glaucoma with prior glaucoma filtering surgery.
  3. IOP above the target range or visual field progression.
  4. Have given written informed consent, prior to any investigational procedures.
  5. Ability to attend for the 6-month duration of treatment.

Exclusion Criteria:

  1. Closed angle glaucoma (primary or secondary).
  2. Known hypersensitivity to any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics.
  3. 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).
  4. Any abnormality preventing reliable applanation tonometry of the treated eye.
  5. Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study.
  6. Participation in any investigational study within the past 30 days.
  7. Inability to perform reliable visual field testing.
  8. Unwilling to sign the consent form approved by the Institutional Review Board (IRB) of the New York Eye and Ear Infirmary.
  9. Self-reported poor compliance to treatment.
  10. Reluctance to return for scheduled follow-up visits.
  11. Patients not able to understand the nature of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02173223


Locations
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United States, New York
Glaucoma Associates of New York
New York, New York, United States, 10003
Sponsors and Collaborators
New York Glaucoma Research Institute

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Responsible Party: Jessica Jasien, Co-Investigator, New York Glaucoma Research Institute
ClinicalTrials.gov Identifier: NCT02173223     History of Changes
Other Study ID Numbers: 14.14
First Posted: June 24, 2014    Key Record Dates
Last Update Posted: April 24, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases
Ophthalmic Solutions
Antihypertensive Agents
Pharmaceutical Solutions