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

Study Overview
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Brief Summary
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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').

Official Title
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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

Conditions
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Rhegmatogenous Retinal Detachment, Proliferative Vitreoretinopathy

Intervention / Treatment
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* Drug: Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA]
* Drug: Glycerin 0.2%/Hypromellose 0.2%/Peg 1%/Soln,Oph,Ud


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Netarsudil 0.02%<br>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 | Drug: Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA]<br>* 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<br>* Other names: Rhopressa;|
| Placebo Comparator: Artificial tears<br>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 | Drug: Glycerin 0.2%/Hypromellose 0.2%/Peg 1%/Soln,Oph,Ud<br>* 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<br>* Other names: Geri-Care Artificial Tears;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Single surgery anatomic success (retinal re-attachment) rate | Successful retinal re-attachment after the primary surgery without requiring additional surgical interventions. | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed on ophthalmic examination at all time points. | Adverse events of interest include endophthalmitis, intraocular inflammation, or retinal tear/detachment. | Six months | 
| The number of participants with evidence of grade C proliferative vitreoretinopathy (PVR) on retinal examination. | PVR Grade C is defined by preretinal or subretinal retinal membrane, including a retinal star fold | Six months | 
| The number of participants with an epiretinal membrane as assessed on ocular examination or optical coherence tomography imaging | Epiretinal membrane is defined as preretinal membrane overlying the macula. | Six months | 
| Change from baseline in visual acuity (Snellen) wearing habitual correction. | Visual acuity will be measured using a typical Snellen chart. | Six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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retinal detachment, rhegmatogenous, proliferative vitreoretinopathy, rho kinase, netarsudil, rhopressa