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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
Conditions: Rhegmatogenous Retinal Detachment, Proliferative Vitreoretinopathy
Sex: All
Ages: 18 Years – N/A
Phase: PHASE2, PHASE3
Enrollment: 80
Sponsor: Wills Eye
Location: United States
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').
Eligibility Criteria
Inclusion Criteria: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.Consents to surgical repair with pars plana vitrectomy with or without scleral bucklingWilling and able to comply with clinic visits and study-related proceduresAble to provide a signed informed consentExclusion Criteria:A patient who meets any of the following criteria will be excluded from the study:Age < 18 yearsPresence of PVR grade B or worse (as defined by the revised Retina Society PVR classification system) at time of surgical repairPrimary RRD repair is primary laser demarcation, primary cryotherapy, pneumatic retinopexy, or scleral buckling procedure alone.Primary use of silicone oil or retinectomy during surgical repairPrior incisional ocular surgery other than cataract extractionHistory of or concurrent ruptured globe, intraocular foreign body, diabetic retinopathy, retinal vein occlusion, exudative age-related macular degeneration, macular hole, epiretinal membrane, sickle cell disease, uveitis or intraocular infectious diseaseNot willing or unable to comply with clinic visits and study-related proceduresUnable to provide a signed informed consent
Source: ClinicalTrials.gov (NCT05660447). StuddyBuddy aggregates publicly available trial information.