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

Sponsor
Wills Eye (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05660447
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
12.4
Anticipated Duration (Months)
6.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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').

Condition or Disease Intervention/Treatment Phase
  • Drug: Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA]
  • Drug: Glycerin 0.2%/Hypromellose 0.2%/Peg 1%/Soln,Oph,Ud
 Phase 2/Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official 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
Anticipated Study Start Date :
Dec 19, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Netarsudil 0.02%

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

Drug: Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA]
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

    		•
    Placebo Comparator: Artificial tears

    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

    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
    Other Names:
  • Geri-Care Artificial Tears

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Single surgery anatomic success (retinal re-attachment) rate [Six months]

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

    Secondary Outcome Measures

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

      Epiretinal membrane is defined as preretinal membrane overlying the macula.

    4. Change from baseline in visual acuity (Snellen) wearing habitual correction. [Six months]

      Visual acuity will be measured using a typical Snellen chart.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Wills Eye Physicians - Mid Atlantic Retina Philadelphia Pennsylvania United States 19107

    Sponsors and Collaborators

    • Wills Eye

    Investigators

    • Principal Investigator: Jason Hsu, MD, Wills Eye Physicians-Mid Atlantic Retina, Wills Eye Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Jason Hsu, MD, Co-Director, Retina Research; Associate Professor, Sidney Kimmel Medical College at Thomas Jefferson University, Wills Eye
    ClinicalTrials.gov Identifier:
    NCT05660447
    Other Study ID Numbers:
    • IRB #2022-77
    First Posted:
    Dec 21, 2022
    Last Update Posted:
    Dec 21, 2022
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Jason Hsu, MD, Co-Director, Retina Research; Associate Professor, Sidney Kimmel Medical College at Thomas Jefferson University, Wills Eye
    retinal detachment
    rhegmatogenous
    proliferative vitreoretinopathy
    rho kinase
    netarsudil
    rhopressa
    Additional relevant MeSH terms:
    Retinal Detachment
    Vitreoretinopathy, Proliferative
    Ophthalmic Solutions
    Lubricant Eye Drops
    Glycerol

    Study Results

    No Results Posted as of Dec 21, 2022