NCT05660447

A Multi-Center Study on the Use of Rho-Kinase Inhibitor to Reduce or Prevent PVR in RRD Eyes at High Risk for PVR

A Multi-Center, Randomized, Double-Blind, Placebo Controlled, Study on the Use of Rho-Kinase Inhibitor to Reduce Ore Prevent Proliferative Vitreoretinopathy (PVR) in Eyes With Rhegmatogenous Retinal Detachment (RRD) at High Risk of PVR

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Wills Eye · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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. Patients eligible for this study are those diagnosed with a rhegmatogenous retinal detachment deemed at high risk for scar tissue formation (a process called 'proliferative vitreoretinopathy').

Conditions

• Rhegmatogenous Retinal Detachment
• Proliferative Vitreoretinopathy

Interventions

Type	Name	Description
DRUG	Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA]	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
DRUG	Glycerin 0.2%/Hypromellose 0.2%/Peg 1%/Soln,Oph,Ud	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

Timeline

• Start date: 2023-02-06
• Primary completion: 2024-12-31
• Completion: 2025-01-31
• First posted: 2022-12-21
• Last updated: 2024-07-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study