Rhopressa for Glaucoma

Overseen By Rebecca Goldfaden, PharmD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: East Coast Institute for Research

Must not be taking: Rho kinase inhibitors

Disqualifiers: Advanced glaucoma, Retinal disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to collect data about how Rhopressa affects IOP in patients who have had an SLT procedure in both eyes.

Will I have to stop taking my current medications?

If you are currently taking IOP-lowering medications, you must be willing to stop them to participate in this trial. There is a required washout period (time without taking certain medications) before starting the study.

Is Rhopressa (netarsudil) safe for humans?

Rhopressa (netarsudil) is generally considered safe for humans, with the most common side effect being mild redness in the eyes. Serious side effects are rare, likely because the drug doesn't spread much beyond the eye. ^{1 2 3 4 5}

How is the drug Rhopressa unique for treating glaucoma?

Rhopressa (netarsudil) is unique because it lowers eye pressure by increasing fluid outflow through the eye's natural drainage system, the trabecular meshwork, using a once-daily evening dose. This mechanism is different from many other glaucoma treatments, which often reduce fluid production or increase outflow through alternative pathways. ^{1 2 3 5 6}

What data supports the effectiveness of the drug Rhopressa (netarsudil) for treating glaucoma?

Research shows that Rhopressa (netarsudil) effectively lowers eye pressure in people with open-angle glaucoma or high eye pressure, with studies indicating it works as well as another common treatment, timolol. It helps by improving fluid drainage in the eye, and most side effects are mild, like eye redness. ^{1 2 3 5 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with primary open-angle glaucoma or ocular hypertension who've had SLT surgery in the last 90 days. They should have an IOP of 16-28 mmHg and could benefit from further IOP reduction. Women must use birth control if capable of pregnancy. Exclusions include more than one SLT treatment, prior MIGS, current rho kinase inhibitor use, advanced glaucoma, unreliable tonometry readings, active eye infections or inflammation, retinal disease, recent investigational drug/device involvement.

Inclusion Criteria

I have been diagnosed with glaucoma or high eye pressure in both eyes.

I had laser eye surgery in both eyes within the last 3 months.

Mean diurnal intraocular pressure (IOP) of 16 to 28 mmHg at Randomization (V2)

Exclusion Criteria

I have had SLT treatment in my eye more than once.

I have had surgery for glaucoma.

I cannot or do not want to stop my current eye pressure medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Rhopressa or placebo for IOP reduction post-SLT

6 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Netarsudil ophthalmic solution 0.02%

Trial Overview The study tests Rhopressa's effect on intraocular pressure (IOP) in patients post-selective laser trabeculoplasty (SLT). Participants will receive Netarsudil ophthalmic solution 0.02% to see if it can further reduce their IOP compared to artificial tears as a control.

How Is the Trial Designed?

Group I: Rhopressa Experimental Treatment 1 Intervention

Group II: Artificial Tears Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

East Coast Institute for Research

Lead Sponsor

Trials

4

Recruited

340+

Alcon, a Novartis Company

Industry Sponsor

Trials

15

Recruited

2,600+

Florida Eye Specialists

Collaborator

Trials

2

Recruited

170+

Published Research Related to This Trial

In a study of 133 glaucoma patients prescribed netarsudil, the medication led to a modest average reduction in intra-ocular pressure (IOP) of -0.8 mmHg, with 67% of eyes showing a decrease, indicating variable efficacy in this population.

However, netarsudil had a high discontinuation rate of 52%, primarily due to reasons such as the need for surgery, allergies, and cost, highlighting challenges in patient compliance and the need for careful consideration of treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pragmatic adjunctive usage of netarsudil: A retrospective chart review from a tertiary care center. Goergen, NS., Gagrani, M., Gulati, V., et al.[2022]

Netarsudil ophthalmic solution 0.02% is a newly approved treatment for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension, working by enhancing aqueous humour outflow through the trabecular meshwork.

The recommended dosage is one drop in the affected eye(s) once daily in the evening, and further clinical development is ongoing in Europe and Japan.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Netarsudil Ophthalmic Solution 0.02%: First Global Approval. Hoy, SM.[2019]

Netarsudil ophthalmic solution 0.02% effectively lowers intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, showing significant reductions in IOP comparable to the standard treatment of twice-daily timolol over three months in phase III trials.

The most common side effect was mild conjunctival hyperemia, which did not worsen with continued use, and netarsudil had minimal serious or systemic adverse effects, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Netarsudil ophthalmic solution 0.02% for the treatment of patients with open-angle glaucoma or ocular hypertension. Kopczynski, CC., Heah, T.[2019]

Rhopressa (netarsudil) is an effective treatment for open-angle glaucoma that works by inhibiting norepinephrine transport and Rho-associated protein kinase (ROCK), but it can cause side effects like conjunctival hyperemia.

This case report highlights a unique instance of Rhopressa-induced corneal edema in a 79-year-old woman without prior corneal issues, suggesting that there may be unknown effects of the treatment that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rhopressa-induced corneal edema: a case report. Chu, MJ., Song, M., Palmares, T., et al.[2021]

In a study of 340 eyes from 233 glaucoma patients, netarsudil 0.02% significantly reduced intraocular pressure (IOP) by at least 20% in 48% of eyes after one month, with effects maintained over six months, even in patients already using multiple glaucoma medications.

While netarsudil was generally safe, 27.6% of patients reported conjunctival hyperemia and 31.1% experienced blurred vision, though these did not lead to significant visual acuity loss; 15.6% discontinued due to insufficient IOP-lowering effects or side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness and safety profile of netarsudil 0.02% in glaucoma treatment: real-world 6-month outcomes. Shiuey, EJ., Mehran, NA., Ustaoglu, M., et al.[2022]

Citations

1. India pubmed.ncbi.nlm.nih.gov

Pragmatic adjunctive usage of netarsudil: A retrospective chart review from a tertiary care center. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Netarsudil Ophthalmic Solution 0.02%: First Global Approval. [2019]

3. Spain pubmed.ncbi.nlm.nih.gov

Netarsudil ophthalmic solution 0.02% for the treatment of patients with open-angle glaucoma or ocular hypertension. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Long-term Safety and Ocular Hypotensive Efficacy Evaluation of Netarsudil Ophthalmic Solution: Rho Kinase Elevated IOP Treatment Trial (ROCKET-2). [2019]

5. England pubmed.ncbi.nlm.nih.gov

Rhopressa-induced corneal edema: a case report. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

The effectiveness and safety profile of netarsudil 0.02% in glaucoma treatment: real-world 6-month outcomes. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of topically administered netarsudil (Rhopressa™) in normal and glaucomatous dogs with ADAMTS10-open-angle glaucoma (ADAMTS10-OAG). [2022]