Status unknownNCT05660447Updated Jul 30, 2024

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 Phase 2/3 interventional study of Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA] and Glycerin 0.2%/Hypromellose 0.2%/Peg 1%/Soln,Oph,Ud in Rhegmatogenous Retinal Detachment and Proliferative Vitreoretinopathy, sponsored by Wills Eye. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-30.

Sponsored by Wills Eye · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2024), so the status shown — last known as Active, not recruiting — may be out of date.

Phase: Phase 2/3
Study type: Interventional
Enrollment: 80
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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').

Conditions studied

Rhegmatogenous Retinal Detachment
Proliferative Vitreoretinopathy

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Keywords

retinal detachment
rhegmatogenous
proliferative vitreoretinopathy
rho kinase
netarsudil
rhopressa

In context

Vitreoretinopathy, Proliferative

39 studies on the registry are indexed under Vitreoretinopathy, Proliferative; 9 are open to participants now.

This study's planned enrollment of 80 is above the median of 61 across 28 interventional studies indexed under Vitreoretinopathy, Proliferative.

Browse Vitreoretinopathy, Proliferative studies →

Lead sponsor

Wills Eye is the lead sponsor of 77 studies on the registry; 2 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 10 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

Study design

Phase: Phase 2 / Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Outcomes assessor)
Enrollment: 80 participants (estimated)

Study arms

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]
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

Interventions

DrugNetarsudil 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
Also known as: Rhopressa
DrugGlycerin 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
Also known as: Geri-Care Artificial Tears

What researchers measure

Primary outcomes

Single surgery anatomic success (retinal re-attachment) rate
Successful retinal re-attachment after the primary surgery without requiring additional surgical interventions.
Time frame: Six months

Secondary outcomes

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.
Time frame: 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
Time frame: 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.
Time frame: Six months
Change from baseline in visual acuity (Snellen) wearing habitual correction.
Visual acuity will be measured using a typical Snellen chart.
Time frame: Six months

Study locations

1 site

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

References and documents

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. PubMed 28660097 ↗
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. PubMed 32235252 ↗
Momenaei B, Ni R, Zhang J, Yonekawa Y, Kuriyan AE, Sivalingam MD, Deaner JD, Orlin A, Cohen MN, Klufas MA, Garg SJ, Ho AC, Xu D, Vander JF, Chiang A, Kaiser RS, Hsu J. Pilot Clinical Trial of Topical Netarsudil to Lower Risk of Proliferative Vitreoretinopathy in High-Risk Primary Retinal Detachment. J Vitreoretin Dis. 2026 Aug 6:24741264261469002. doi: 10.1177/24741264261469002. Online ahead of print. PubMed 42568743 ↗

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Started Feb 2023 (actual). Primary completion is estimated for Dec 2024, 22 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered: Dec 3, 2022
First posted: Dec 21, 2022
StartActual: Feb 6, 2023
Primary completionEst.: Dec 31, 2024
CompletionEst.: Jan 31, 2025
Last update: Jul 30, 2024

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jul 30, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05660447
Lead sponsor: Wills Eye
Responsible party: Jason Hsu, MD (Co-Director, Retina Research; Associate Professor, Sidney Kimmel Medical College at Thomas Jefferson University, Wills Eye) — Principal investigator
First posted: Dec 21, 2022
Start date: Feb 6, 2023
Primary completion: Dec 31, 2024 (estimated)
Completion: Jan 31, 2025 (estimated)
Last update: Jul 30, 2024

Study contacts

Jason Hsu, MD

principal investigator · Wills Eye Physicians-Mid Atlantic Retina, Wills Eye Hospital

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Netarsudil

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