Netarsudil for Retinal Detachment

Overseen By Jason Hsu, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Wills Eye

Disqualifiers: Age < 18, Diabetic retinopathy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether netarsudil (an ophthalmic solution) can safely prevent scar tissue formation after retinal detachment surgery. Retinal detachment occurs when the retina, a layer of tissue in the eye, pulls away from its normal position. The study seeks participants at high risk for scar tissue formation after retinal detachment repair, particularly those with multiple retinal breaks or a detachment lasting over three weeks. Participants will use either netarsudil eye drops or a placebo (artificial tears) following surgery. This trial suits individuals willing to adhere to study procedures and without certain eye conditions or treatments. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that netarsudil 0.02% is generally well-tolerated by patients. In earlier studies, some experienced side effects like eye redness, known as conjunctival hyperemia, occurring in about 42% of participants. However, many found the treatment manageable and continued its use.

Netarsudil is already approved for lowering eye pressure in other eye conditions, indicating its relative safety. Current research explores its use for preventing scar tissue after retinal detachment surgery. While this new application is still under study, safety data from past studies provides some reassurance. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for retinal detachment?

Unlike the standard treatments for retinal detachment, which typically involve surgical repair techniques, netarsudil offers a unique approach by using a rho-kinase (ROCK) inhibitor. This medication is applied as an eye drop, making it less invasive compared to traditional methods. Researchers are excited because netarsudil targets the cellular mechanisms that may promote healing and reduce complications, potentially improving outcomes for patients after surgery. This novel mechanism and delivery method could represent a significant advancement in retinal detachment care.

What evidence suggests that netarsudil might be an effective treatment for retinal detachment?

Research has shown that netarsudil eye drops effectively lower eye pressure, crucial for treating certain eye conditions. Studies have found that netarsudil performs as well as timolol, a common eye pressure medication. It blocks a protein called rho-kinase, aiding eye fluid drainage and influencing scar formation. In this trial, one group of participants will receive netarsudil to explore its potential to reduce scarring after retinal detachment surgery, especially in high-risk patients. Meanwhile, the control group will receive artificial tears as a placebo. ^{1 3 5 6 7}

Who Is on the Research Team?

Jason Hsu, MD

Principal Investigator

Wills Eye Physicians-Mid Atlantic Retina, Wills Eye Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Willing and able to comply with clinic visits and study-related procedures

Able to provide a signed informed consent

A patient must meet the following criteria to be eligible for inclusion in the study: Diagnosed with primary RRD at high risk for PVR development. Specifically, the enrolled eye must include at least 1 but no more than 3 high risk features, which are designated as follows: multiple retinal breaks (3 or more); detachments involving two or more quadrants of the retina; duration of detachment > 3 weeks; vitreous hemorrhage; and choroidal detachment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either netarsudil or placebo once daily in the evening starting on postoperative day 1 after RRD repair surgery, till post-operative day 56

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments for proliferative vitreoretinopathy and visual acuity

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Glycerin 0.2%/Hypromellose 0.2%/Peg 1%/Soln,Oph,Ud
• Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA]

Trial Overview

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.

How Is the Trial Designed?

Group I: Netarsudil 0.02% Experimental Treatment 1 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 tears Placebo Group 1 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

Who Is Running the Clinical Trial?

Wills Eye

Lead Sponsor

Trials

81

Recruited

15,400+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05660447

A Multi-Center Study on the Use of Rho-Kinase Inhibitor to ...

The purpose of this study is to determine if a drug called netarsudil is safe and able to prevent the development of scar tissue after retinal detachment repair ...

2.

withpower.com

withpower.com/trial/phase-2-and-3-retinal-detachment-11-2022-3e1c0

Netarsudil for Retinal Detachment · Info for Participants

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 ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7647436/

Pooled Efficacy and Safety Profile of Netarsudil Ophthalmic ...

In pooled phase III analyses, once-daily netarsudil 0.02% resulted in intraocular pressure (IOP) reduction that was noninferior to twice-daily timolol 0.5%, ...

4.

rhopressa.myalcon.com

rhopressa.myalcon.com/ecp/efficacy/

Efficacy | RHOPRESSA® for ECPs

Take control with RHOPRESSA®. (netarsudil ophthalmic solution) 0.02%. RHOPRESSA® provided IOP reduction up to 5 mmHg in patients with baselines <25 mmHg1.

5.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/nda/2019/208259Orig1s000MedR.pdf

208259Orig1s000 CLINICAL REVIEW(S) - accessdata.fda.gov

Integrated Assessment of Effectiveness. The data contained in this submission establishes the efficacy of netarsudil/latanoprost ophthalmic ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8328041/

Real-World Clinical Impact of Netarsudil 0.02% at ...

The IOP reduction from baseline was about 3 mmHg. Fifty-four patients (42%) experienced an AE (eg, conjunctival hyperemia). Thirty-eight patients (29%) started ...

7.

cdek.pharmacy.purdue.edu

cdek.pharmacy.purdue.edu/trial/NCT05660447/

Trial | NCT05660447

The purpose of this study is to determine if a drug called netarsudil is safe and able to prevent the development of scar tissue after retinal detachment ...