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
| Registry | NCT05660447 |
|---|---|
| Status | Unknown |
| Phase | Phase 2 / Phase 3 |
| Study type | Interventional; randomized, parallel, masking: triple, treatment |
| Enrollment | 80 (Estimated) |
| Sponsor | Wills Eye (Other) |
| Conditions | Rhegmatogenous Retinal Detachment, Proliferative Vitreoretinopathy |
| Interventions | Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA], Glycerin 0.2%/Hypromellose 0.2%/Peg 1%/Soln,Oph,Ud (Drug) |
| Dates | start 2023-02-06, primary completion 2024-12-31 (estimated), completion 2025-01-31 (estimated), first posted 2022-12-21, last updated 2024-07-30 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Rhegmatogenous Retinal Detachment All trials for Proliferative Vitreoretinopathy All trials of Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA] All trials of Glycerin 0.2%/Hypromellose 0.2%/Peg 1%/Soln,Oph,Ud
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').
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Netarsudil 0.02% | Experimental | Drug: 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 |
| Artificial tears | Placebo comparator | Drug: 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 |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Wills Eye Physicians - Mid Atlantic Retina | Philadelphia, Pennsylvania | United States |