A Phase 2 interventional study of Rho-Kinase Inhibitor in Advanced Glaucoma, sponsored by New York Glaucoma Research Institute. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-24.
Sponsored by New York Glaucoma Research Institute · Phase 2, Interventional, and Treatment
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.
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's planned enrollment of 10 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.
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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 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
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.
Time frame: 6 Months
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.
Time frame: 6 Months
This study is status unknown, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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New York Glaucoma Research Institute