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

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').

Study Overview

• Status: Active, not recruiting
• Conditions: Rhegmatogenous Retinal Detachment; Proliferative Vitreoretinopathy
• Intervention / Treatment: Drug: Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA]; Drug: Glycerin 0.2%/Hypromellose 0.2%/Peg 1%/Soln,Oph,Ud

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Wills Eye Physicians - Mid Atlantic Retina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

A patient must meet the following criteria to be eligible for inclusion in the study:

1. 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.
2. Consents to surgical repair with pars plana vitrectomy with or without scleral buckling
3. Willing and able to comply with clinic visits and study-related procedures
4. Able to provide a signed informed consent

Exclusion Criteria:

A patient who meets any of the following criteria will be excluded from the study:

1. Age < 18 years
2. Presence of PVR grade B or worse (as defined by the revised Retina Society PVR classification system) at time of surgical repair
3. Primary RRD repair is primary laser demarcation, primary cryotherapy, pneumatic retinopexy, or scleral buckling procedure alone.
4. Primary use of silicone oil or retinectomy during surgical repair
5. Prior incisional ocular surgery other than cataract extraction
6. 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
7. Not willing or unable to comply with clinic visits and study-related procedures
8. Unable to provide a signed informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Netarsudil 0.02%; 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]; 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; Other Names: Rhopressa
Placebo Comparator: Artificial tears; 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; 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; Other Names: Geri-Care Artificial Tears

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Wills Eye
• Investigators: Principal Investigator: Jason Hsu, MD, Wills Eye Physicians-Mid Atlantic Retina, Wills Eye Hospital

Publications and helpful links

General Publications

• Townes-Anderson E, Wang J, Halasz E, Sugino I, Pitler A, Whitehead I, Zarbin M. Fasudil, a Clinically Used ROCK Inhibitor, Stabilizes Rod Photoreceptor Synapses after Retinal Detachment. Transl Vis Sci Technol. 2017 Jun 20;6(3):22. doi: 10.1167/tvst.6.3.22. eCollection 2017 Jun.
• Halasz E, Townes-Anderson E, Zarbin MA. Improving outcomes in retinal detachment: the potential role of rho-kinase inhibitors. Curr Opin Ophthalmol. 2020 May;31(3):192-198. doi: 10.1097/ICU.0000000000000658.

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: December 3, 2022
• First Submitted That Met QC Criteria: December 13, 2022
• First Posted (Actual): December 21, 2022

Study Record Updates

• Last Update Posted (Actual): July 30, 2024
• Last Update Submitted That Met QC Criteria: July 27, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: retinal detachment; proliferative vitreoretinopathy; rhegmatogenous; rho kinase; netarsudil; rhopressa
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Detachment; Vitreoretinopathy, Proliferative; Physiological Effects of Drugs; Protective Agents; Pharmaceutical Solutions; Cryoprotective Agents; Ophthalmic Solutions; Glycerol; Lubricant Eye Drops
• Other Study ID Numbers: IRB #2022-77

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes