A Multi-Center Study on the Use of Rho-Kinase Inhibitor to Reduce or Prevent PVR in RRD Eyes at High Risk for PVR
Rhegmatogenous Retinal Detachment, Proliferative Vitreoretinopathy
About this trial
This is an interventional treatment trial for Rhegmatogenous Retinal Detachment focused on measuring retinal detachment, rhegmatogenous, proliferative vitreoretinopathy, rho kinase, netarsudil, rhopressa
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 buckling Willing and able to comply with clinic visits and study-related procedures Able to provide a signed informed consent Exclusion Criteria: A patient who meets any of the following criteria will be excluded from the study: Age < 18 years Presence of PVR grade B or worse (as defined by the revised Retina Society PVR classification system) at time of surgical repair Primary RRD repair is primary laser demarcation, primary cryotherapy, pneumatic retinopexy, or scleral buckling procedure alone. Primary use of silicone oil or retinectomy during surgical repair Prior incisional ocular surgery other than cataract extraction History 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 disease Not willing or unable to comply with clinic visits and study-related procedures Unable to provide a signed informed consent
Sites / Locations
- Wills Eye Physicians - Mid Atlantic RetinaRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Netarsudil 0.02%
Artificial tears
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
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