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

Phase 2

Active, not recruiting

• Conditions: Proliferative Vitreoretinopathy; Rhegmatogenous Retinal Detachment
• Interventions: Drug: Glycerin 0.2%/Hypromellose 0.2%/Peg 1%/Soln,Oph,Ud; Drug: Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA]

• Registration Number: NCT05660447
• Lead Sponsor: Wills Eye

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').

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-03
• Study First Submitted QC: 2022-12-13
• Study First Posted: 2022-12-21
• Study Start: 2023-02-06
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-27
• Last Update Posted: 2024-07-30
• Primary Completion: 2024-12-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Artificial tears	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
Netarsudil 0.02%	Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA]	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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Wills Eye Physicians - Mid Atlantic Retina; 🇺🇸 Philadelphia, Pennsylvania, United States