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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').
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Single surgery anatomic success (retinal re-attachment) rate | Successful retinal re-attachment after the primary surgery without requiring additional surgical interventions. | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| The number of participants with evidence of grade C proliferative vitreoretinopathy (PVR) on retinal examination. |
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Inclusion Criteria:
A patient must meet the following criteria to be eligible for inclusion in the study:
Exclusion Criteria:
A patient who meets any of the following criteria will be excluded from the study:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Hsu, MD | Wills Eye Physicians-Mid Atlantic Retina, Wills Eye Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wills Eye Physicians - Mid Atlantic Retina | Philadelphia | Pennsylvania | 19107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28660097 | Background | 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. | |
| 32235252 | 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. |
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|
| 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 |
|
|
PVR Grade C is defined by preretinal or subretinal retinal membrane, including a retinal star fold |
| 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. | Six months |
| Change from baseline in visual acuity (Snellen) wearing habitual correction. | Visual acuity will be measured using a typical Snellen chart. | Six months |
| ID | Term |
|---|---|
| D018630 | Vitreoretinopathy, Proliferative |
| D012163 | Retinal Detachment |
| D009477 | Hereditary Sensory and Autonomic Neuropathies |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
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| ID | Term |
|---|---|
| C000603944 | netarsudil |
| D009883 | Ophthalmic Solutions |
| D005990 | Glycerol |
| D065347 | Hypromellose Derivatives |
| D011092 | Polyethylene Glycols |
| ID | Term |
|---|---|
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
| D000073999 | Triose Sugar Alcohols |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
| D002482 | Cellulose |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D005026 | Ethylene Glycols |
| D006018 | Glycols |
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