A Multi-Center Study on the Use of Rho-Kinase Inhibitor to Reduce or Prevent PVR in RRD Eyes at H… (NCT05660447) | Clinical Trial Compass
Active — Not RecruitingPhase 2/3
A Multi-Center Study on the Use of Rho-Kinase Inhibitor to Reduce or Prevent PVR in RRD Eyes at High Risk for PVR
United States80 participantsStarted 2023-02-06
Plain-language 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').
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
✕. 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
✕
What they're measuring
1
Single surgery anatomic success (retinal re-attachment) rate