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

Rhegmatogenous Retinal Detachment Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05660447
• Other study ID #: IRB #2022-77
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: February 6, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Wills Eye
• Contact: Hana Mansour, MD
• Phone: 215-928-3444
• Email: hana.mansour100[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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').

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Proliferative Vitreoretinopathy
• Retinal Detachment
• Rhegmatogenous Retinal Detachment

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Wills Eye Physicians - Mid Atlantic Retina	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Wills Eye

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Single surgery anatomic success (retinal re-attachment) rate	Successful retinal re-attachment after the primary surgery without requiring additional surgical interventions.	Six months
Secondary	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.	Six months
Secondary	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	Six months
Secondary	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.	Six months
Secondary	Change from baseline in visual acuity (Snellen) wearing habitual correction.	Visual acuity will be measured using a typical Snellen chart.	Six months