Rhegmatogenous Retinal DetachmentPhase 2/3NCT05660447
A Multi-Center Study on the Use of Rho-Kinase Inhibitor to Reduce or Prevent PVR in RRD Eyes at High Risk for PVR
A Phase 2/3 study testing Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA] and Glycerin 0.2%/Hypromellose 0.2%/Peg 1%/Soln,Oph,Ud in people with Rhegmatogenous Retinal Detachment and Proliferative Vitreoretinopathy, run by Wills Eye at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhegmatogenous Retinal Detachment, Proliferative Vitreoretinopathy
- What is being tested?
- Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA] and Glycerin 0.2%/Hypromellose 0.2%/Peg 1%/Soln,Oph,Ud
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2023to 31 Jan 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wills Eye Physicians - Mid Atlantic Retina
Philadelphia, Pennsylvania, 19107
About this study
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
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').
- Being tested
- Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA], Glycerin 0.2%/Hypromellose 0.2%/Peg 1%/Soln,Oph,Ud
- Keywords
- retinal detachment, rhegmatogenous, proliferative vitreoretinopathy, rho kinase, netarsudil, rhopressa
- Medical subject headings
- Vitreoretinopathy, Proliferative, Retinal Detachment, Hereditary Sensory and Autonomic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA]Drug
Also called 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,UdDrug
Also called Geri-Care 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Glycerin 0.2%/Hypromellose 0.2%/Peg 1%/Soln,Oph,Ud |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single surgery anatomic success (retinal re-attachment) rate
Successful retinal re-attachment after the primary surgery without requiring additional surgical interventions.
Measured: Six months
Secondary outcomes (4)
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.
Measured: Six months
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
Measured: Six months
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.
Measured: Six months
Change from baseline in visual acuity (Snellen) wearing habitual correction.
Visual acuity will be measured using a typical Snellen chart.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start6 Feb 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rhegmatogenous Retinal DetachmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wills Eye
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Hsu, MD, Wills Eye
- Investigators
- Jason Hsu, MD, Principal investigator, Wills Eye Physicians-Mid Atlantic Retina, Wills Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05660447
- Sponsor's protocol ID
- IRB #2022-77
- Status last verified
- Jul 2024
- First submitted
- 3 Dec 2022
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28660097Halasz 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.
PubMed 32235252Momenaei B, Ni R, Zhang J, Yonekawa Y, Kuriyan AE, Sivalingam MD, Deaner JD, Orlin A, Cohen MN, Klufas MA, Garg SJ, Ho AC, Xu D, Vander JF, Chiang A, Kaiser RS, Hsu J. Pilot Clinical Trial of Topical Netarsudil to Lower Risk of Proliferative Vitreoretinopathy in High-Risk Primary Retinal Detachment. J Vitreoretin Dis. 2026 Aug 6:24741264261469002. doi: 10.1177/24741264261469002. Online ahead of print.
PubMed 42568743
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05660447
- Acronym / sponsor ID
- IRB #2022-77
- Keywords
- retinal detachment, rhegmatogenous, proliferative vitreoretinopathy, rho kinase, netarsudil, rhopressa
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Wills EyeUniversity, hospital or other
- Study start
- 6 Feb 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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').
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Netarsudil 0.02% | Experimental | Drug: Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA]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 |
| Artificial tears | Placebo comparator | Drug: Glycerin 0.2%/Hypromellose 0.2%/Peg 1%/Soln,Oph,UdPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA]Also: RhopressaOne 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% |
| Glycerin 0.2%/Hypromellose 0.2%/Peg 1%/Soln,Oph,UdAlso: Geri-Care Artificial TearsPatients 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 | Artificial tears |
Primary outcome
Single surgery anatomic success (retinal re-attachment) rate
Time frame: Six months
Successful retinal re-attachment after the primary surgery without requiring additional surgical interventions.
4 secondary outcomes
Number of participants with treatment-related adverse events as assessed on ophthalmic examination at all time points.
Time frame: Six months
The number of participants with evidence of grade C proliferative vitreoretinopathy (PVR) on retinal examination.
Time frame: Six months
The number of participants with an epiretinal membrane as assessed on ocular examination or optical coherence tomography imaging
Time frame: Six months
Change from baseline in visual acuity (Snellen) wearing habitual correction.
Time frame: Six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Background: PubMed 28660097Townes-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.
- Background: PubMed 32235252Halasz 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.
- Derived from this study: PubMed 42568743Momenaei B, Ni R, Zhang J, Yonekawa Y, Kuriyan AE, Sivalingam MD, Deaner JD, Orlin A, Cohen MN, Klufas MA, Garg SJ, Ho AC, Xu D, Vander JF, Chiang A, Kaiser RS, Hsu J. Pilot Clinical Trial of Topical Netarsudil to Lower Risk of Proliferative Vitreoretinopathy in High-Risk Primary Retinal Detachment. J Vitreoretin Dis. 2026 Aug 6:24741264261469002. doi: 10.1177/24741264261469002. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Rhegmatogenous Retinal Detachment
RecruitingPhase 2
Prevention of ProliFerative Vitreoretinopathy With Intravitreal MethotreXate in Primary Retinal DEtachment Repair (FIXER) Trial
Proliferative Vitreoretinopathy, Rhegmatogenous Retinal Detachment
RecruitingPhase 3
Treatment of Retinal Detachment in People Who Have Not Had Cataract Surgery With Vitrectomy vs Vitrectomy and Cataract Removal
Rhegmatogenous Retinal Detachment
Active, not recruiting
Ocular Hypotony and Refractive Predictability in RRD Surgery
Rhegmatogenous Retinal Detachment, Hypotony Ocular
RecruitingPhase 1/2
Topical Netarsudil for the Prevention of Proliferative Vitreoretinopathy in Patients With Retinal Detachment
Rhegmatogenous Retinal Detachment, Proliferative Vitreoretinopathy
Not yet recruitingPhase 1
The Safety and Efficacy of Intravitreal Topotecan for the Treatment of Proliferative Vitreoretinopathy
Proliferative Vitreoretinopathy, Proliferative Vitreo-Retinopathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Hsu, MD principal investigator
Wills Eye Physicians-Mid Atlantic Retina, Wills Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Netarsudil 0.02% Ophthalmic Solution [RHOPRESSA] and Glycerin 0.2%/Hypromellose 0.2%/Peg 1%/Soln,Oph,Ud in people with Rhegmatogenous Retinal Detachment and Proliferative Vitreoretinopathy, run by Wills Eye at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single surgery anatomic success (retinal re-attachment) rate (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05660447, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.