Pilot Clinical Trial of Topical Netarsudil to Lower Risk of Proliferative Vitreoretinopathy in High-Risk Primary Retinal Detachment
Bita Momenaei, Roselind Ni, Jingwen Zhang, Yoshihiro Yonekawa, Ajay E. Kuriyan, Meera D. Sivalingam, Jordan D. Deaner, Anton Orlin, Michael N. Cohen, Michael A. Klufas, Sunir J. Garg, Allen C. Ho, David Xu, James F. Vander, Allen Chiang, Richard S. Kaiser, Jason HsuPurpose:
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 (
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.