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

80 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jason Hsu, MD

Principal Investigator

Wills Eye Physicians-Mid Atlantic Retina, Wills Eye Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+