What side effects are associated with this type of intervention?

Common treatments for Proliferative Vitreoretinopathy (PVR) include surgical interventions and pharmacological agents aimed at reducing fibrosis and scar tissue formation. Netarsudil, a Rho kinase inhibitor, is being studied for its potential to prevent scar tissue after retinal detachment repair. Known side effects of Rho kinase inhibitors like Netarsudil may include conjunctival hyperemia (eye redness), corneal verticillata (whorled patterns on the cornea), and increased intraocular pressure. Other treatments for PVR, such as corticosteroids and anti-VEGF agents, can have side effects including cataracts, elevated intraocular pressure, and potential for infection. It is important to discuss these potential side effects with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved drugs exclusively for the treatment of Proliferative Vitreoretinopathy (PVR). However, various approaches have been explored, including the use of corticosteroids and anti-inflammatory agents to manage inflammation and fibrosis. Netarsudil, a Rho kinase inhibitor, is currently being studied for its potential to reduce fibrosis and scar tissue formation in PVR, representing a novel therapeutic approach. Other treatments under investigation include different anti-fibrotic agents and inhibitors targeting cellular pathways involved in scar tissue formation.

What other types of research exist?

Promising alternatives to Netarsudil for Proliferative Vitreoretinopathy (PVR) patients include aflibercept, which has shown efficacy in treating retinal conditions such as retinopathy of prematurity and diabetic retinopathy, and RNA interference targeting HIF-1α, which has been effective in reducing retinal neovascularization in retinopathy of prematurity. These treatments could potentially be explored for their applicability in PVR.

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Rho-Kinase Inhibitor

Netarsudil for Retinal Detachment

Phase 2 & 3

Waitlist Available

Led By Jason Hsu, MD

Research Sponsored by Wills Eye

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up six months

Summary

This trial is testing if the drug netarsudil can safely prevent scar tissue after surgery for a detached retina. It focuses on patients with a high risk of developing scar tissue, which can make recovery harder. The drug works by stopping the cells from forming this problematic scar tissue.

Who is the study for?

This trial is for adults with a specific type of retinal detachment at high risk for scar tissue formation after surgery. Participants must be willing to follow the study plan and have had no prior significant eye surgeries, except cataract extraction.

What is being tested?

The study tests if netarsudil can prevent scar tissue in eyes at risk after retinal detachment repair. Patients will receive netarsudil or a control solution post-surgery to see which is more effective in preventing proliferative vitreoretinopathy.

What are the potential side effects?

Netarsudil may cause side effects like redness, discomfort in the eye, cornea problems, and changes in vision. The severity of these side effects varies from person to person.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ six months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~six months

This trial's timeline: 3 weeks for screening, Varies for treatment, and six months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Single surgery anatomic success (retinal re-attachment) rate

Secondary study objectives

Change from baseline in visual acuity (Snellen) wearing habitual correction.

Number of participants with treatment-related adverse events as assessed on ophthalmic examination at all time points.

The number of participants with an epiretinal membrane as assessed on ocular examination or optical coherence tomography imaging

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Netarsudil 0.02%Experimental Treatment1 Intervention

For the study arm: one drop of rho-kinase (ROCK) inhibitor in the vitrectomized eye, once daily in the evening starting on postoperative day 1 after RRD repair surgery, till post-operative day 56

Group II: Artificial tearsPlacebo Group1 Intervention

Patients enrolled in the control group will receive a placebo (one drop of artificial tears) once daily in the evening starting on postoperative day 1 after RRD repair surgery, till post-operative day 56

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Proliferative Vitreoretinopathy (PVR) is characterized by the formation of scar tissue that can lead to retinal detachment. Treatments like Rho kinase inhibitors, such as Netarsudil, work by reducing fibrosis and scar tissue formation, which are critical in preventing the progression of PVR. These inhibitors block the Rho/ROCK pathway, which is involved in cellular contraction, migration, and extracellular matrix production, thereby minimizing the formation of fibrotic tissue. This mechanism is crucial for PVR patients as it helps maintain retinal attachment and preserves vision. Other treatments may include anti-inflammatory agents and anti-proliferative drugs, which also aim to reduce cellular proliferation and inflammation, further preventing scar tissue development.

Vascular Normalization by ROCK Inhibitor: Therapeutic Potential of Ripasudil (K-115) Eye Drop in Retinal Angiogenesis and Hypoxia.