Netarsudil vs Brimonidine for Normal Tension Glaucoma
Recruiting in Palo Alto (17 mi)
+3 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Westlake Eye Specialists
Must be taking: Latanoprost
Must not be taking: Brimonidine, Netarsudil
Disqualifiers: Angle closure glaucoma, Secondary glaucoma, others
No Placebo Group
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?A randomized, multicenter, investigator-masked prospective study of NTG patients currently on latanoprost 0.005% monotherapy, to study the effect of IOP change with the introduction of netarsudil 0.02% vs brimonidine 0.1%. Subjects will be assessed at a screening visit, and 1 follow-up visit. Clinical evaluations will include visual acuity and IOP .
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does require that you continue using latanoprost 0.005% monotherapy.
What data supports the effectiveness of the drug Netarsudil for treating normal tension glaucoma?
Research shows that Netarsudil is effective in lowering eye pressure in patients with open-angle glaucoma and ocular hypertension, which are conditions similar to normal tension glaucoma. It works by increasing the outflow of fluid in the eye, leading to significant reductions in eye pressure.
12345Is Netarsudil safe for use in humans?
Netarsudil has been shown to be generally safe in humans, with the most common side effect being mild redness in the eyes. Serious side effects are rare, likely because the drug does not spread much beyond the eye.
12356What makes the drug Netarsudil unique for treating normal tension glaucoma?
Netarsudil is unique because it is a Rho kinase inhibitor that lowers intraocular pressure by increasing the outflow of fluid through the eye's trabecular meshwork, which is different from other treatments that often reduce fluid production or increase outflow through different pathways. It is administered as an eye drop once daily in the evening, and it has a mild side effect profile with minimal systemic exposure.
24789Eligibility Criteria
This trial is for patients with Normal Tension Glaucoma (NTG) who are already using latanoprost. Participants should be stable on their current treatment and available for a screening visit and at least one follow-up. Specific inclusion or exclusion criteria were not provided.Inclusion Criteria
I am 18 years old or older.
I have normal tension glaucoma and have been on latanoprost for 6 weeks.
Exclusion Criteria
I have a type of glaucoma that is not primary.
I have a specific type of glaucoma not caused by high eye pressure alone.
I am an adult without cognitive impairments and not critically ill.
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
1 visit (in-person)
Treatment
Participants receive either netarsudil 0.02% or brimonidine 0.1% in addition to latanoprost 0.005% for 6 weeks
6 weeks
Regular assessments including visual acuity and IOP
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
1 visit (in-person)
Participant Groups
The study compares the effect of adding netarsudil versus brimonidine to NTG patients' existing latanoprost regimen on intraocular pressure (IOP). It's a randomized, multicenter trial where participants won't know which additional medication they're receiving.
2Treatment groups
Experimental Treatment
Active Control
Group I: NetarsudilExperimental Treatment1 Intervention
netarsudil 0.02%
Group II: BrimonidineActive Control1 Intervention
brimonidine 0.1%
Netarsudil is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Rhopressa for:
- Open-angle glaucoma
- Ocular hypertension
🇪🇺 Approved in European Union as Rhokiinsa for:
- Open-angle glaucoma
- Ocular hypertension
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Westlake Eye Specialists - Austin OfficeAustin, TX
Westlake Eye Specialists - Killeen OfficeKilleen, TX
Westlake Eye Specialists - Kyle OfficeKyle, TX
Westlake Eye Specialists - New Braunfels OfficeNew Braunfels, TX
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Who Is Running the Clinical Trial?
Westlake Eye SpecialistsLead Sponsor
SengiIndustry Sponsor
References
The effectiveness and safety profile of netarsudil 0.02% in glaucoma treatment: real-world 6-month outcomes. [2022]To evaluate the efficacy and safety profile of netarsudil 0.02% ophthalmic solution in a tertiary glaucoma referral center.
Netarsudil ophthalmic solution 0.02% for the treatment of patients with open-angle glaucoma or ocular hypertension. [2019]Once-daily (p.m.) netarsudil ophthalmic solution 0.02% (Rhopressa) is approved in the United States for lowering elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Netarsudil, a Rho kinase (ROCK) inhibitor that lowers IOP primarily by increasing trabecular outflow, produces statistically and clinically significant reductions in mean IOP from baseline, with comparable effects on nocturnal and diurnal IOP. In three phase III trials of patients with elevated IOP, the ocular hypotensive efficacy of once-daily netarsudil 0.02% met the criteria for noninferiority to twice-daily timolol 0.5% at all time points over 3 months in patients with baseline IOP less than 25 mmHg. The most frequent adverse event (AE) was generally mild conjunctival hyperemia, the severity of which did not increase with continued dosing. Netarsudil was associated with minimal treatment-related serious or systemic AEs, likely due to the lack of systemic exposure. This report summarizes the available preclinical and clinical data on netarsudil.
Two Phase 3 Clinical Trials Comparing the Safety and Efficacy of Netarsudil to Timolol in Patients With Elevated Intraocular Pressure: Rho Kinase Elevated IOP Treatment Trial 1 and 2 (ROCKET-1 and ROCKET-2). [2019]To evaluate the efficacy and ocular and systemic safety of netarsudil 0.02% ophthalmic solution, a rho-kinase inhibitor and norepinephrine transporter inhibitor, in patients with open-angle glaucoma and ocular hypertension.
Comparison of Netarsudil/Latanoprost Therapy with Latanoprost Monotherapy for Lowering Intraocular Pressure: A Systematic Review and Meta-analysis. [2022]Netarsudil is a Rho kinase inhibitor and the first new class of clinically useful ocular hypotensive agents. In this study, we conducted a systematic literature review and meta-analysis to summarize and synthesize the available evidence on the efficacy and safety of fixed-dose combination (FDC) therapy with netarsudil/latanoprost in patients with glaucoma.
Pragmatic adjunctive usage of netarsudil: A retrospective chart review from a tertiary care center. [2022]This retrospective chart review of netarsudil (Rhopressa) characterizes intra-ocular pressure (IOP) reduction, drug tolerance, drug cost, and compliance in a tertiary university Midwest clinic in a variety of glaucoma diagnoses on patients prescribed netarsudil 01/2017 to 5/2020.
The Effects of Netarsudil Ophthalmic Solution on Aqueous Humor Dynamics in a Randomized Study in Humans. [2019]Netarsudil, an inhibitor of Rho kinase and a norepinephrine transporter, has been shown to lower elevated intraocular pressure (IOP) in controlled studies of patients with open-angle glaucoma and ocular hypertension, and in healthy volunteers. The mechanism of this ocular hypotensive effect in humans is unknown.
Rhopressa-induced corneal edema: a case report. [2021]Rhopressa (netarsudil) has recently been added to the arsenal of treatment for open-angle glaucoma. It is an effective norepinephrine transporter and Rho-associated protein kinase (ROCK) inhibitor used to decrease intraocular pressure (IOP), with the most common side effect being conjunctival hyperemia.
Netarsudil Ophthalmic Solution 0.02%: First Global Approval. [2019]Netarsudil ophthalmic solution 0.02% (hereafter referred to as netarsudil 0.02%) [Rhopressa®] is a Rho-associated protein kinase inhibitor that is thought to lower intraocular pressure (IOP) by increasing aqueous humour outflow through the trabecular meshwork. It has been developed by Aerie Pharmaceuticals and was recently approved in the USA for the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension. The recommended dosage is one drop in the affected eye(s) once daily in the evening. Phase III development in the EU and phase II development in Japan are underway for this indication. This article summarizes the milestones in the development of netarsudil 0.02% leading to this first approval for the reduction of elevated IOP in patients with open-angle glaucoma or ocular hypertension.
[ROCK (RHO-KINASE INHIBITORS) FOR THE TREATMENT OF OPEN-ANGLE GLAUCOMA AND OCULAR HYPERTENSION]. [2023]Netarsudil ophthalmic solution 0.02% is a new treatment for open-angle glaucoma and ocular hypertension, which was approved for treatment in the United States and in the European Commission. The drug is a rho- kinase inhibitor (ROCK) that lowers intraocular pressure by enhancing the outflow at the trabecular meshwork and decreasing both aqueous humor production and episcleral venous pressure. This literature review aims to present this new treatment, characterize its specific mechanism of action, and discuss its effect and adverse events profile. The efficacy and safety of the drug were studied in the ROCKET and MERCURY clinical trials, in which Netarsudil was compared to other common drugs, including Timolol (Beta-blocker), Latanoprost (Prostaglandin analog), and a combination drop containing Netarsudil and Latanoprost. These trials showed a reduction of 16%-21% in the intraocular pressure (IOP) when using Netarsudil. Moreover, it was found that when using a combination of Netarsudil and Latanoprost, 64.5% of these patients achieved ≥30% reduction in mean diurnal IOP versus 28.8% of patients treated only with Netarsudil and 37.2% of patients treated only with Latanoprost (P