Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

This is an open-label, randomized study that will test the safety and pharmacokinetics of topical netarsudil at a dose frequency of once-daily in two cohorts of patients: those with primary rhegmatogenous detachments, and those with established proliferative vitreoretinopathy. The intervention will be topical application of Netarsudil from time of diagnosis of retinal detachment to 16 weeks post-operatively. Patients will be randomized to one of the following groups: - The primary rhegmatogenous detachment cohort: A total of 24 study subjects (24 eyes) will be stratified by their lens status (12 phakic versus 12 pseudophakic). All patients will receive once per day dosing of netarsudil. - The proliferative vitreoretinopathy cohort: A total of 24 study subjects (24 eyes) will be stratified by their lens status (12 phakic versus 12 pseudophakic). All patients will receive once per day dosing of netarsudil. After surgery, patients will continue on either once per day dosing of Netarsudil. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06033703
Study type Interventional
Source Massachusetts Eye and Ear Infirmary
Contact Leo Kim, MD, PhD
Phone 6175237900
Email Leo_Kim@meei.harvard.edu
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date February 2024
Completion date December 2024

See also
  Status Clinical Trial Phase
Recruiting NCT04403750 - Combined Laser-surgical Technology of RRD Treatment N/A
Not yet recruiting NCT04520789 - Early Prevention Strategies of Severe Proliferative Vitreoretinopathy Base on Precision Diagnosis of Single Cell Sequencingvitreoretinopathy N/A
Recruiting NCT04571788 - Treating Rhegmatogenous Retinal Detachment by Foldable Capsular Buckle
Completed NCT02834559 - Prophylactic Intravitreal 5-Fluorouracil and Heparin to Prevent PVR in High-risk Patients With Retinal Detachment. Phase 3
Recruiting NCT01845571 - Retinal Detachment - Demographic and Clinical Survey
Completed NCT04891991 - Intravitreal Infliximab for Proliferative Vitreoretinopathy Phase 2
Recruiting NCT02871531 - Pneumatic Retinopexy Versus Vitrectomy for Retinal Detachment in Patients With Extended Criteria N/A
Completed NCT00757536 - Primary Vitrectomy With Endolaser or Encircling Band for Rhegmatogenous Retinal Detachment N/A
Active, not recruiting NCT00370201 - Efficacy of Oral Colchicine in Prevention of Proliferative Vitreoretinopathy in Rhegmatogenous Retinal Detachment Phase 3
Completed NCT00345007 - Macular Function After Scleral Buckle N/A
Recruiting NCT05331664 - Dropless Pars Plana Vitrectomy Study Phase 4
Completed NCT02841306 - Ursodeoxycholic Acid for Rhegmatogenous Retinal Detachment Phase 1
Not yet recruiting NCT02185469 - Corneal Endothelial Cell Loss After Pneumatic Retinopexy for the Repair of Primary Rhegmatogenous Retinal Detachment N/A
Not yet recruiting NCT01647373 - Axial Length Change in Eyes Treated by Silicone Sponge Scleral Buckling N/A
Completed NCT01068379 - Clinical Trial of Cryotherapy Versus Postoperative Laser Photocoagulation Phase 3
Not yet recruiting NCT06425419 - The Safety and Efficacy of Intravitreal Topotecan for the Treatment of Proliferative Vitreoretinopathy Phase 1
Not yet recruiting NCT06468397 - Acute Retinal Detachment Repair With the iSeelr^TM Retinal Detachment Repair System N/A
Recruiting NCT06056596 - Lamivudine and Plasma Markers of Inflammation in Retinal Detachment Early Phase 1
Completed NCT01343134 - Anatomical and Functional Macular Changes in Retinal Detachment N/A
Recruiting NCT05588037 - Combined Vitrectomy and Femtosecond Laser-assisted Cataract Surgery N/A