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

Status unconfirmed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Rhegmatogenous Retinal Detachment, Proliferative Vitreoretinopathy

In brief

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').

Key facts

Study ID

NCT05660447

Run by

Wills Eye

People needed

80

Starts

2023-02-06

Expected to finish

2025-01-31

Last updated by the study team

2024-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.