Rhegmatogenous Retinal Detachment Clinical Trial
Official title:
Topical Netarsudil for the Prevention of Proliferative Vitreoretinopathy in Patients With Primary Rhegmatogenous Detachments and Retinal Detachment Due to Proliferative Vitreoretinopathy or Open-Globe Injury: A Phase I/II Clinical Trial
This study has two main objectives. The first objective is to study the pharmacokinetics of topical netarsudil administration in the posterior segment of the eye, where netarsudil must exert its effect in order to prevent formation of tractional membranes. The second objective is to assess the safety profile of topical netarsudil in the pre- and post-operative periods. A secondary objective of the study is to begin to assess signs of efficacy in preventing formation of tractional membranes post-operatively.
Status | Not yet recruiting |
Enrollment | 48 |
Est. completion date | December 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | The primary rhegmatogenous detachment cohort will have the following selection criteria: Inclusion criteria: - Patients > 18 years old - Patients presenting for primary rhegmatogenous retinal detachment repair within 7 days of symptom onset - Patients undergoing vitrectomy or vitrectomy with scleral buckle Exclusion criteria: - Patient unable to give consent - Patient unable to follow-up - Prior history of retinal detachment incisional surgery in presenting eye - Prior history of open globe injury to presenting eye - Prior history of glaucoma surgery to presenting eye I.e., Status post trabeculectomy, Ahmed tube placement, minimally invasive glaucoma surgery, actively on glaucoma medication - Prior history of corneal disease, or history of corneal edema - Patient already on topical netarsudil in presenting eye - Patient without natural lens or intraocular lens implant (I.e., aphakic patients) - Patients with intraocular pressure <8mm Hg in operative eye - Active or chronic or recurrent uncontrolled ocular or systemic disease - Active or history of chronic or recurrent inflammatory eye disease - Diagnosis of proliferative diabetic retinopathy - Signs of ocular infection at presentation in either eye - Known or suspected sensitivity or allergy to any of the medications used in the operation or postoperatively - Inability to use/ apply topical eye drops The proliferative vitreoretinopathy cohort will have the following selection criteria: Inclusion criteria: - Patients > 18 years old - Patient presenting with retinal detachment due with proliferative vitreoretinopathy (grade C or higher) or retinal detachment associated with open globe trauma - Patients undergoing vitrectomy or vitrectomy with scleral buckle Exclusion criteria: - Patient unable to give consent - Patient unable to follow-up - Prior history of glaucoma surgery to presenting eye I.e., Status post trabeculectomy, Ahmed tube placement, minimally invasive glaucoma surgery - Patient already on topical netarsudil in presenting eye - Patients with intraocular pressure <8mm Hg in operative eye - Active or chronic or recurrent uncontrolled ocular or systemic disease - Active or history of chronic or recurrent inflammatory eye disease - Diagnosis of severe nonproliferative or proliferative diabetic retinopathy or vasoproliferative disease in operative eye - Signs of ocular infection at presentation in either eye - Known or suspected sensitivity or allergy to any of the medications used in the operation or postoperatively - Inability to use/ apply topical eye drops - No Light Perception vision in operative eye - Failure to achieve intraoperative reattachment - Patient with silicone oil instilled in operative eye at time of presentation |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Massachusetts Eye and Ear Infirmary |
Davies E, Jurkunas U, Pineda R 2nd. Pilot Study of Corneal Clearance With the Use of a Rho-Kinase Inhibitor After Descemetorhexis Without Endothelial Keratoplasty for Fuchs Endothelial Corneal Dystrophy. Cornea. 2021 Jul 1;40(7):899-902. doi: 10.1097/ICO.0000000000002691. — View Citation
Fernandez MM. Reticular Epithelial Edema in Edematous Corneas Treated with Netarsudil. Ophthalmology. 2018 Nov;125(11):1709. doi: 10.1016/j.ophtha.2018.08.004. No abstract available. — View Citation
Kahook MY, Serle JB, Mah FS, Kim T, Raizman MB, Heah T, Ramirez-Davis N, Kopczynski CC, Usner DW, Novack GD; ROCKET-2 Study Group. Long-term Safety and Ocular Hypotensive Efficacy Evaluation of Netarsudil Ophthalmic Solution: Rho Kinase Elevated IOP Treatment Trial (ROCKET-2). Am J Ophthalmol. 2019 Apr;200:130-137. doi: 10.1016/j.ajo.2019.01.003. Epub 2019 Jan 15. — View Citation
Lin CW, Sherman B, Moore LA, Laethem CL, Lu DW, Pattabiraman PP, Rao PV, deLong MA, Kopczynski CC. Discovery and Preclinical Development of Netarsudil, a Novel Ocular Hypotensive Agent for the Treatment of Glaucoma. J Ocul Pharmacol Ther. 2018 Jan/Feb;34(1-2):40-51. doi: 10.1089/jop.2017.0023. Epub 2017 Jun 13. — View Citation
LoBue SA, Moustafa GA, Vu A, Amin M, Nguyen T, Goyal H. Transient Reticular Cystic Corneal Epithelial Edema With Topical Netarsudil: A Case Series and Review. Cornea. 2021 Aug 1;40(8):1048-1054. doi: 10.1097/ICO.0000000000002621. — View Citation
Serle JB, Katz LJ, McLaurin E, Heah T, Ramirez-Davis N, Usner DW, Novack GD, Kopczynski CC; ROCKET-1 and ROCKET-2 Study Groups. Two Phase 3 Clinical Trials Comparing the Safety and Efficacy of Netarsudil to Timolol in Patients With Elevated Intraocular Pressure: Rho Kinase Elevated IOP Treatment Trial 1 and 2 (ROCKET-1 and ROCKET-2). Am J Ophthalmol. 2018 Feb;186:116-127. doi: 10.1016/j.ajo.2017.11.019. Epub 2017 Dec 1. — View Citation
Singh IP, Fechtner RD, Myers JS, Kim T, Usner DW, McKee H, Sheng H, Lewis RA, Heah T, Kopczynski CC. Pooled Efficacy and Safety Profile of Netarsudil Ophthalmic Solution 0.02% in Patients With Open-angle Glaucoma or Ocular Hypertension. J Glaucoma. 2020 Oct;29(10):878-884. doi: 10.1097/IJG.0000000000001634. — View Citation
Wisely CE, Liu KC, Gupta D, Carlson AN, Asrani SG, Kim T. Reticular Bullous Epithelial Edema in Corneas Treated with Netarsudil: A Case Series. Am J Ophthalmol. 2020 Sep;217:20-26. doi: 10.1016/j.ajo.2020.04.002. Epub 2020 Apr 11. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The concentration of netarsudil in the vitreous to assess its pharmacokinetic properties. | Netarsudil concentration in the posterior segment of the eye, using High-performance liquid chromatography (HPLC) | Through study completion, an average of 1 year | |
Primary | Serious adverse events | Unexpected serious adverse events | Day 1, 7, 28, 56, 84, 126, and 168 after surgery | |
Secondary | Number of operations within 3 months | Total number of operation during the first 3 months after surgery | Day 84 after surgery | |
Secondary | Final attachment status at last follow-up | Status of the retina (attached versus detached) at last follow-up visit | Day 168 after surgery | |
Secondary | Visual acuity | Best-corrected visual acuity measured using Snellen chart | Day 1, 7, 28, 56, 84, 126, and 168 after surgery | |
Secondary | Spectral domain optical coherence tomography (SD-OCT) of the macula | Status of the macula (mac-on versus mac-off) | Day 1, 7, 28, 56, 84, 126, and 168 after surgery | |
Secondary | Adverse events | Adverse events including conjunctival injection, subconjunctival hemorrhage, and corneal verticillata, eye irritation, reticular edema of the cornea, hypotony | Day 1, 7, 28, 56, 84, 126, and 168 after surgery |
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