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Trial record 44 of 1614 for:    glaucoma

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

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ClinicalTrials.gov Identifier: NCT02174991
Recruitment Status : Unknown
Verified April 2015 by Jessica Jasien, New York Glaucoma Research Institute.
Recruitment status was:  Active, not recruiting
First Posted : June 26, 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 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.


Condition or disease Intervention/treatment Phase
Glaucoma Drug: Rho-Kinase Inhibitor (AR-12286) 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: 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 : June 2014
Actual Primary Completion Date : February 2015

Resource links provided by the National Library of Medicine


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)



Primary Outcome Measures :
  1. IOP Reduction [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02174991


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: NCT02174991     History of Changes
Other Study ID Numbers: 14.15
First Posted: June 26, 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