Chronic Angle-closure GlaucomaPhase 2ROCK - CACGNCT02152774
A Study to Assess the Effect of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Patients With Chronic Angle-closure Glaucoma
A Phase 2 study testing Rho-Kinase Inhibitor in people with Chronic Angle-closure Glaucoma, run by New York Glaucoma Research Institute at 1 site in United States.
Trial summary
To evaluate the ocular hypotensive efficacy of Rho kinase Inhibitor (AR-12286 0.5% and 0.7%) ophthalmic solutions in patients diagnosed with chronic angle-closure glaucoma treated for 6 months. Secondary Outcome Secondary objectives are: 1. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Chronic Angle-closure Glaucoma
- What is being tested?
- Rho-Kinase Inhibitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Feb 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 50 and 85 years old; of either sex.
- Patients with CACG with ≥180⁰ PAS
- IOP ≥22 mmHg prior to initiation of treatment in one or both eyes with two measurements taken two hours apart
- No previous intraocular surgery except clear cornea phacoemulsification.
- Corrected visual acuity in both eyes ≥20/50 in the eligible eye
- Not more than 6 diopters spherical equivalent on the study eye
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- Not more than 3 diopters cylinder equivalent on the study eye
- Have given written informed consent, prior to any investigational procedures.
- Ability to attend for the 6-month duration of the study
Who cannot join
- Open angle glaucoma
- Closed angle glaucoma with <180⁰ PAS
- Intraocular pressure >35 mmHg
- Severe glaucomatous damage
- Known hypersensitivity to any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics.
- Previous intraocular surgery except clear cornea phacoemulsification.
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- Clinically significant ocular disease (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study.
- Ocular medication of any kind within 30 days of base-line visit, with the exception of ocular hypotensive medications and/or drops for treatment of dry eye syndrome (which may be used throughout the study).
- Any abnormality preventing reliable applanation tonometry of either eye.
- Clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study.
- Changes of systemic medication that could have a substantial effect on IOP anticipated during the study.
- Participation in any investigational study within the past 30 days.
- Inability to perform reliable VF 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Glaucoma Associates of New York
New York, New York, 10003
About this study
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 Chronic Angle-closure Glaucoma
To evaluate the ocular hypotensive efficacy of Rho kinase Inhibitor (AR-12286 0.5% and 0.7%) ophthalmic solutions in patients diagnosed with chronic angle-closure glaucoma treated for 6 months.
Secondary Outcome
Secondary objectives are:
- To evaluate the early effect of Rho kinase Inhibitor (AR-12286) in reducing intraocular pressure (IOP).
- To evaluate the long term effect of the drug on IOP.
- To determine if AR-12286 can be used as directed therapy for CACG, reducing or eliminating the structural blockage of the trabecular meshwork that leads to development of elevated IOP.
- Conditions
- Chronic Angle-closure Glaucoma
- Being tested
- Rho-Kinase Inhibitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rho-Kinase InhibitorDrug
| Study group | Role | What they receive |
|---|---|---|
| 0.5% Rho-Kinase Inhibitor | Experimental | AR-12286 is a novel, potent Rho-kinase inhibitor developed by Aerie Pharmaceuticals, Inc., Bridgewater, NJ. It has single-digit nanomolar inhibitory activity against Rho-kinase in enzymatic inhibition assays. Mechanism-of action studies in monkeys demonstrate that AR-12286 lowers IOP primarily by increasing aqueous humor outflow through the trabecular meshwork 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 patients and the only side effect was ocular hyperemia in a minority of subjects. It is currently in phase II testing. Receives: Drug: Rho-Kinase Inhibitor |
| 0.7% Rho-Kinase Inhibitor | Experimental | AR-12286 is a novel, potent Rho-kinase inhibitor developed by Aerie Pharmaceuticals, Inc., Bridgewater, NJ. It has single-digit nanomolar inhibitory activity against Rho-kinase in enzymatic inhibition assays. Mechanism-of action studies in monkeys demonstrate that AR-12286 lowers IOP primarily by increasing aqueous humor outflow through the trabecular meshwork 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 patients and the only side effect was ocular hyperemia in a minority of subjects. It is currently in phase II testing. Receives: Drug: Rho-Kinase Inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long Lasting 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 diagnosed with CACG treated for 6 months.
Measured: 6 Months
Secondary outcomes (1)
Secondary Outcome
To determine if AR-12286 can be used as directed therapy for CACG, reducing or eliminating the structural blockage of the trabecular meshwork that leads to development of elevated IOP.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Angle-closure GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York Glaucoma Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica Jasien, New York Glaucoma Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02152774
- Sponsor's protocol ID
- 14.12
- Acronym
- ROCK - CACG
- Status last verified
- Apr 2015
- First submitted
- 23 May 2014
- Last updated
- 24 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Chronic Angle-closure Glaucoma
- ClinicalTrials.gov ID
- NCT02152774
- Acronym / sponsor ID
- ROCK - CACG / 14.12
- Conditions
- Chronic Angle-closure Glaucoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- New York Glaucoma Research InstituteUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Feb 2015 (actual)
- First posted
- 2 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the ocular hypotensive efficacy of Rho kinase Inhibitor (AR-12286 0.5% and 0.7%) ophthalmic solutions in patients diagnosed with chronic angle-closure glaucoma treated for 6 months.
Secondary Outcome
Secondary objectives are:
- To evaluate the early effect of Rho kinase Inhibitor (AR-12286) in reducing intraocular pressure (IOP).
- To evaluate the long term effect of the drug on IOP.
- To determine if AR-12286 can be used as directed therapy for CACG, reducing or eliminating the structural blockage of the trabecular meshwork that leads to development of elevated IOP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.5% Rho-Kinase Inhibitor | Experimental | Drug: Rho-Kinase InhibitorAR-12286 is a novel, potent Rho-kinase inhibitor developed by Aerie Pharmaceuticals, Inc., Bridgewater, NJ. It has single-digit nanomolar inhibitory activity against Rho-kinase in enzymatic inhibition assays. Mechanism-of action studies in monkeys demonstrate that AR-12286 lowers IOP primarily by increasing aqueous humor outflow through the trabecular meshwork 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 patients and the only side effect was ocular hyperemia in a minority of subjects. It is currently in phase II testing. |
| 0.7% Rho-Kinase Inhibitor | Experimental | Drug: Rho-Kinase InhibitorAR-12286 is a novel, potent Rho-kinase inhibitor developed by Aerie Pharmaceuticals, Inc., Bridgewater, NJ. It has single-digit nanomolar inhibitory activity against Rho-kinase in enzymatic inhibition assays. Mechanism-of action studies in monkeys demonstrate that AR-12286 lowers IOP primarily by increasing aqueous humor outflow through the trabecular meshwork 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 patients and the only side effect was ocular hyperemia in a minority of subjects. It is currently in phase II testing. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients between 50 and 85 years old; of either sex.
- Patients with CACG with ≥180⁰ PAS
- IOP ≥22 mmHg prior to initiation of treatment in one or both eyes with two measurements taken two hours apart
- No previous intraocular surgery except clear cornea phacoemulsification.
- Corrected visual acuity in both eyes ≥20/50 in the eligible eye
Key exclusion criteria (17 listed)
- Open angle glaucoma
- Closed angle glaucoma with <180⁰ PAS
- Intraocular pressure >35 mmHg
- Severe glaucomatous damage
- Known hypersensitivity to any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rho-Kinase Inhibitor | Drug | 0.5% Rho-Kinase Inhibitor, 0.7% Rho-Kinase Inhibitor |
Primary outcome
Long Lasting 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 diagnosed with CACG treated for 6 months.
1 secondary outcome
Secondary Outcome
Time frame: 6 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rho-Kinase Inhibitor in people with Chronic Angle-closure Glaucoma, run by New York Glaucoma Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long Lasting effect of study drug to reduce IOP (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2015.