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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Wills Eye
Study ID
NCT05660447
Phase
PHASE2/PHASE3
Status
Active Not Recruiting

Conditions

  • Proliferative Vitreoretinopathy
  • Rhegmatogenous Retinal Detachment

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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
  • 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

Study Details

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').

Key Dates

Start date
Feb 6, 2023
Status verified
Jul 2024
Primary completion
Dec 31, 2024
Completion
Jan 31, 2025

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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
  • 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

Primary Outcome Measure

Single surgery anatomic success (retinal re-attachment) rate [ Time Frame: Six months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Wills Eye Physicians - Mid Atlantic RetinaPhiladelphiaPennsylvania19107-

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By research site
Wills Eye Physicians - Mid Atlantic Retina· Philadelphia, PA

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