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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

Primary Purpose

Rhegmatogenous Retinal Detachment, Proliferative Vitreoretinopathy

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA]
Glycerin 0.2%/Hypromellose 0.2%/Peg 1%/Soln,Oph,Ud
Sponsored by
Wills Eye
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhegmatogenous Retinal Detachment focused on measuring retinal detachment, rhegmatogenous, proliferative vitreoretinopathy, rho kinase, netarsudil, rhopressa

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wills Eye Physicians - Mid Atlantic RetinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Netarsudil 0.02%

Artificial tears

Arm Description

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

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

Outcomes

Primary Outcome Measures

Single surgery anatomic success (retinal re-attachment) rate
Successful retinal re-attachment after the primary surgery without requiring additional surgical interventions.

Secondary Outcome Measures

Number of participants with treatment-related adverse events as assessed on ophthalmic examination at all time points.
Adverse events of interest include endophthalmitis, intraocular inflammation, or retinal tear/detachment.
The number of participants with evidence of grade C proliferative vitreoretinopathy (PVR) on retinal examination.
PVR Grade C is defined by preretinal or subretinal retinal membrane, including a retinal star fold
The number of participants with an epiretinal membrane as assessed on ocular examination or optical coherence tomography imaging
Epiretinal membrane is defined as preretinal membrane overlying the macula.
Change from baseline in visual acuity (Snellen) wearing habitual correction.
Visual acuity will be measured using a typical Snellen chart.

Full Information

First Posted
December 3, 2022
Last Updated
April 24, 2023
Sponsor
Wills Eye
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1. Study Identification

Unique Protocol Identification Number
NCT05660447
Brief Title
A Multi-Center Study on the Use of Rho-Kinase Inhibitor to Reduce or Prevent PVR in RRD Eyes at High Risk for PVR
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 6, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wills Eye

4. Oversight

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
Data Monitoring Committee
No

5. 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').

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhegmatogenous Retinal Detachment, Proliferative Vitreoretinopathy
Keywords
retinal detachment, rhegmatogenous, proliferative vitreoretinopathy, rho kinase, netarsudil, rhopressa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Netarsudil 0.02%
Arm Type
Experimental
Arm Description
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
Arm Title
Artificial tears
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA]
Other Intervention Name(s)
Rhopressa
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Glycerin 0.2%/Hypromellose 0.2%/Peg 1%/Soln,Oph,Ud
Other Intervention Name(s)
Geri-Care Artificial Tears
Intervention Description
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 Information:
Title
Single surgery anatomic success (retinal re-attachment) rate
Description
Successful retinal re-attachment after the primary surgery without requiring additional surgical interventions.
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed on ophthalmic examination at all time points.
Description
Adverse events of interest include endophthalmitis, intraocular inflammation, or retinal tear/detachment.
Time Frame
Six months
Title
The number of participants with evidence of grade C proliferative vitreoretinopathy (PVR) on retinal examination.
Description
PVR Grade C is defined by preretinal or subretinal retinal membrane, including a retinal star fold
Time Frame
Six months
Title
The number of participants with an epiretinal membrane as assessed on ocular examination or optical coherence tomography imaging
Description
Epiretinal membrane is defined as preretinal membrane overlying the macula.
Time Frame
Six months
Title
Change from baseline in visual acuity (Snellen) wearing habitual correction.
Description
Visual acuity will be measured using a typical Snellen chart.
Time Frame
Six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hana Mansour, MD
Phone
215-928-3444
Email
hana.mansour100@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jason Hsu, MD
Phone
215-928-3444
Email
jhsu@midatlanticretina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Hsu, MD
Organizational Affiliation
Wills Eye Physicians-Mid Atlantic Retina, Wills Eye Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wills Eye Physicians - Mid Atlantic Retina
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hana Mansour, MD
Phone
215-928-3444
Email
hmansour@midatlanticretina.com
First Name & Middle Initial & Last Name & Degree
Jason Hsu, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28660097
Citation
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.
Results Reference
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PubMed Identifier
32235252
Citation
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.
Results Reference
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Learn more about this trial

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

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