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 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: IRB #2022-77
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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').

Conditions

Rhegmatogenous Retinal Detachment; Proliferative Vitreoretinopathy

Keywords

retinal detachment; rhegmatogenous; proliferative vitreoretinopathy; rho kinase; netarsudil; rhopressa

Outcome Measures

Primary Outcomes (1)

• Single surgery anatomic success (retinal re-attachment) rate

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

  Six months

Secondary Outcomes (4)

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

  Six months

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

  Six months

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

  Six months

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

  Six months

Study Arms (2)

Netarsudil 0.02%

EXPERIMENTAL

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]

Artificial tears

PLACEBO COMPARATOR

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

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

Also known as: Rhopressa

Netarsudil 0.02%

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

Also known as: Geri-Care Artificial Tears

Artificial tears

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wills Eye: lead

Study Sites (1)

Wills Eye Physicians - Mid Atlantic Retina

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (2)

• Townes-Anderson E, Wang J, Halasz E, Sugino I, Pitler A, Whitehead I, Zarbin M. Fasudil, a Clinically Used ROCK Inhibitor, Stabilizes Rod Photoreceptor Synapses after Retinal Detachment. Transl Vis Sci Technol. 2017 Jun 20;6(3):22. doi: 10.1167/tvst.6.3.22. eCollection 2017 Jun.

  PMID: 28660097 BACKGROUND

• Halasz E, Townes-Anderson E, Zarbin MA. Improving outcomes in retinal detachment: the potential role of rho-kinase inhibitors. Curr Opin Ophthalmol. 2020 May;31(3):192-198. doi: 10.1097/ICU.0000000000000658.

  PMID: 32235252 BACKGROUND

MeSH Terms

Conditions

Vitreoretinopathy, Proliferative; Retinal Detachment; Hereditary Sensory and Autonomic Neuropathies

Interventions

netarsudil; Ophthalmic Solutions; Glycerol; Hypromellose Derivatives; Polyethylene Glycols

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Triose Sugar Alcohols; Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Cellulose; Glucans; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Ethylene Glycols; Glycols

Study Officials

• Jason Hsu, MD

  Wills Eye Physicians-Mid Atlantic Retina, Wills Eye Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director, Retina Research; Associate Professor, Sidney Kimmel Medical College at Thomas Jefferson University

Study Record Dates

• First Submitted: December 3, 2022
• First Posted: December 21, 2022
• Study Start: February 6, 2023
• Primary Completion: December 31, 2024
• Study Completion: January 31, 2025
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)