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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

NCT05660447 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-07-30

No results posted yet for this 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').

Conditions

  • Rhegmatogenous Retinal Detachment
  • Proliferative Vitreoretinopathy

Interventions

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

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

Sponsors & Collaborators

  • Wills Eye

    lead OTHER

Principal Investigators

  • Jason Hsu, MD · Wills Eye Physicians-Mid Atlantic Retina, Wills Eye Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-06
Primary Completion
2024-12-31
Completion
2025-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05660447 on ClinicalTrials.gov