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Active, Not Recruiting

NCT Number: NCT05660447

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

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').

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Rhegmatogenous Retinal Detachment Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Genetic Diseases, Inborn Hereditary Sensory and Autonomic Neuropathies Heredodegenerative Disorders, Nervous System Nervous System Diseases Nervous System Malformations Neurodegenerative Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Polyneuropathies Proliferative Vitreoretinopathy Retinal Detachment Retinal Diseases Vitreoretinopathy, Proliferative

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Wills Eye Physicians - Mid Atlantic Retina

Philadelphia, Pennsylvania, 19107, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA]

Drug

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

Other names: Rhopressa

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

Drug

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

Other names: Geri-Care Artificial Tears

Primary outcomes

  1. Single surgery anatomic success (retinal re-attachment) rate

    Time frame: Six months

    Successful retinal re-attachment after the primary surgery without requiring additional surgical interventions.

Secondary outcomes

  1. Number of participants with treatment-related adverse events as assessed on ophthalmic examination at all time points.

    Time frame: Six months

    Adverse events of interest include endophthalmitis, intraocular inflammation, or retinal tear/detachment.

  2. The number of participants with evidence of grade C proliferative vitreoretinopathy (PVR) on retinal examination.

    Time frame: Six months

    PVR Grade C is defined by preretinal or subretinal retinal membrane, including a retinal star fold

  3. The number of participants with an epiretinal membrane as assessed on ocular examination or optical coherence tomography imaging

    Time frame: Six months

    Epiretinal membrane is defined as preretinal membrane overlying the macula.

  4. Change from baseline in visual acuity (Snellen) wearing habitual correction.

    Time frame: Six months

    Visual acuity will be measured using a typical Snellen chart.

Sponsors and collaborators

Lead sponsor

Wills Eye

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Dec 21, 2022
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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