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Pilot Clinical Trial of Topical Netarsudil to Lower Risk of Proliferative Vitreoretinopathy in High-Risk Primary
Bita Momenaei1, Roselind Ni1,2, Jingwen Zhang1
1The Retina Service of Wills Eye Hospital, Wills Eye Physicians-Mid Atlantic Retina, Thomas Jefferson University, Philadelphia, PA, USA.
Purpose:
To determine whether a topical rho-kinase inhibitor used in eyes with primary rhegmatogenous retinal detachment (RRD) at high risk for proliferative vitreoretinopathy (PVR) reduces the rate of recurrent RD due to grade C or worse PVR.
Methods:
This randomized, double-masked, placebo-controlled trial (ClinicalTrials.gov: NCT05660447) included patients with primary RRD undergoing pars plana vitrectomy (PPV), with or without scleral buckling, who had 1 to 3 PVR risk factors: 3 or more breaks, 2 or more quadrants of RD, RD for longer than 3 weeks, vitreous hemorrhage, or choroidal detachment. Participants were randomized to netarsudil 0.02% or artificial tears, administered once daily for 8 weeks starting on postoperative day 1. The primary outcome was the rate of recurrent RD due to grade C PVR at 6 months.
Results:
A total of 79 patients were randomized (40 to netarsudil, 39 to placebo). After excluding dropouts and those lost to follow-up, 38 netarsudil and 34 placebo participants were analyzed. There was no significant difference in baseline high-risk features for PVR between the netarsudil and placebo arms. Eight eyes (21.1%) in the netarsudil arm vs 6 eyes (17.6%) in the placebo arm developed redetachment (P = .77), with 4 vs 6 of the redetachments due to PVR (10.5% vs 17.6%; P = .5). At 6 months, epiretinal membrane was found in 55.2% of eyes in the netarsudil group and in 63.6% in the placebo group (P > .99). Median logMAR (Snellen equivalent) visual acuity in the netarsudil vs placebo arm was 1.24 (20/350) vs 1.35 (20/450) at baseline (P = .87), 0.7 (20/100) vs 0.48 (20/60) at month 3 (P = .27), and 0.48 (20/60) vs 0.54 (20/70) at month 6 (P = .91).
Conclusions:
Treatment of eyes with primary RRD at high risk for PVR with netarsudil 0.02% once daily for 8 weeks after PPV with or without scleral buckling did not appear to affect PVR redetachment or visual outcomes compared with placebo.