Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Rhegmatogenous Retinal Detachment
Proliferative Vitreoretinopathy
Keywords: retinal detachment
rhegmatogenous
proliferative vitreoretinopathy
rho kinase
netarsudil
rhopressa
Lead sponsor: Wills Eye
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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:

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

Primary outcomes:
measure: Single surgery anatomic success (retinal re-attachment) rate
timeFrame: Six months
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as assessed on ophthalmic examination at all time points.
timeFrame: Six months
measure: The number of participants with evidence of grade C proliferative vitreoretinopathy (PVR) on retinal examination.
timeFrame: Six months
measure: The number of participants with an epiretinal membrane as assessed on ocular examination or optical coherence tomography imaging
timeFrame: Six months
measure: Change from baseline in visual acuity (Snellen) wearing habitual correction.
timeFrame: Six months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Wills Eye Physicians - Mid Atlantic Retina
state: Pennsylvania
Study officials:
affiliation: Wills Eye Physicians-Mid Atlantic Retina, Wills Eye Hospital
name: Jason Hsu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.