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

Last updated: July 27, 2024
Sponsor: Wills Eye
Overall Status: Active - Not Recruiting

Phase

2/3

Condition

Retina

Macular Degeneration

Treatment

Glycerin 0.2%/Hypromellose 0.2%/Peg 1%/Soln,Oph,Ud

Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA]

Clinical Study ID

NCT05660447
IRB #2022-77
  • Ages > 18
  • All Genders

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').

Eligibility Criteria

Inclusion

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, theenrolled eye must include at least 1 but no more than 3 high risk features, whichare designated as follows: multiple retinal breaks (3 or more); detachmentsinvolving 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 scleralbuckling

  3. Willing and able to comply with clinic visits and study-related procedures

  4. Able to provide a signed informed consent

Exclusion

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 PVRclassification system) at time of surgical repair

  3. Primary RRD repair is primary laser demarcation, primary cryotherapy, pneumaticretinopexy, 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, diabeticretinopathy, retinal vein occlusion, exudative age-related macular degeneration,macular hole, epiretinal membrane, sickle cell disease, uveitis or intraocularinfectious 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

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Glycerin 0.2%/Hypromellose 0.2%/Peg 1%/Soln,Oph,Ud
Phase: 2/3
Study Start date:
February 06, 2023
Estimated Completion Date:
January 31, 2025

Connect with a study center

  • Wills Eye Physicians - Mid Atlantic Retina

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

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