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

Wills Eye

Status and phase: Active, not recruiting; Phase 3; Phase 2

Conditions: Proliferative Vitreoretinopathy; Rhegmatogenous Retinal Detachment

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05660447

IRB #2022-77

Details and patient eligibility

About

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').

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

Netarsudil 0.02%

Experimental group

Description:

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

Treatment:

Drug: Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA]

Artificial tears

Placebo Comparator group

Description:

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

Treatment:

Drug: Glycerin 0.2%/Hypromellose 0.2%/Peg 1%/Soln,Oph,Ud