Netarsudil for Retinal Detachment
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how a new eye drop, netarsudil, works for individuals with retinal detachment, a condition where the retina separates from its supporting tissue. The primary goal is to determine if these drops can prevent or reduce the formation of harmful membranes in the eye after surgery. The trial also assesses the safety of the drops before and after surgery. Individuals who recently experienced retinal detachment and are scheduled for specific eye surgeries may qualify for this trial. As a Phase 1/Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking research.
Do I need to stop my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you are already using topical netarsudil in the affected eye, you cannot participate.
Is there any evidence suggesting that this trial's treatment is likely to be safe?
Research has shown that netarsudil is generally safe for people. A study using FDA data found that netarsudil has a good safety record with few serious side effects. Most side effects, such as eye redness or discomfort, were mild and temporary. This suggests that the drug is safe for ocular use, particularly as an eye drop.
While researchers are testing netarsudil for retinal detachment, it is already approved for treating high eye pressure in conditions like glaucoma. This approval indicates some level of safety, though its effects on retinal detachment remain under investigation. Early data from previous studies suggest that netarsudil is promising, but ongoing trials will provide more detailed information about its safety for this specific condition.12345Why do researchers think this study treatment might be promising for retinal detachment?
Researchers are excited about Netarsudil for retinal detachment because it offers a unique approach compared to current treatments like scleral buckling and vitrectomy, which are largely surgical. Netarsudil is administered as an eye drop, providing a non-invasive option that could simplify treatment. It works by targeting the Rho kinase pathway, potentially reducing inflammation and improving healing after retinal detachment repair. This novel mechanism could enhance recovery and outcomes in ways that current surgical methods do not.
What evidence suggests that netarsudil might be an effective treatment for retinal detachment?
Research has shown that netarsudil, a type of medication, can help prevent scarring after surgery to repair a detached retina. In this trial, participants will receive topical Netarsudil ophthalmic solution 0.02% once daily from the time of retinal detachment diagnosis to 16 weeks post-operatively. Studies have found that netarsudil significantly reduces the growth of cells that can cause scars, which is crucial because scarring can lead to post-surgery complications. Additionally, netarsudil reduces blood vessel leaks, swelling, and tissue thickening, common issues in many eye conditions. These findings suggest that netarsudil might effectively prevent complications after retinal detachment surgery.25678
Who Is on the Research Team?
Leo Kim, MD, PhD
Principal Investigator
Massachusetts Eye and Ear
Are You a Good Fit for This Trial?
This trial is for patients who are getting treatment for a detached retina within 7 days of noticing symptoms. It's open to those having a vitrectomy or combined vitrectomy and scleral buckle procedure.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive topical Netarsudil ophthalmic solution 0.02% once per day from time of diagnosis of retinal detachment to 16 weeks post-operatively
Follow-up
Participants are monitored for safety and effectiveness after treatment, including adverse events and visual acuity assessments
What Are the Treatments Tested in This Trial?
Interventions
- Netarsudil
Trial Overview
The study is testing Netarsudil Ophthalmic, an eye drop medication, to see if it can prevent scar tissue from forming in the eye after surgery for retinal detachment.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Pseudophakic patients with retinal detachment due with proliferative vitreoretinopathy (grade C or higher) or retinal detachment associated with open globe trauma, undergoing vitrectomy or vitrectomy with scleral buckle will be included. Patients will receive topical Netarsudil ophthalmic solution 0.02%: once per day, from time of diagnosis of retinal detachment to 16 weeks post-operatively.
Phakic patients with retinal detachment due with proliferative vitreoretinopathy (grade C or higher) or retinal detachment associated with open globe trauma, undergoing vitrectomy or vitrectomy with scleral buckle will be included. Patients will receive topical Netarsudil ophthalmic solution 0.02%: once per day, from time of diagnosis of retinal detachment to 16 weeks post-operatively.
Pseudophakic patients with primary rhegmatogenous retinal detachment repair within 7 days of symptom onset, undergoing vitrectomy or vitrectomy with scleral buckle will be included. Patients will receive topical Netarsudil ophthalmic solution 0.02%: once per day, from time of diagnosis of retinal detachment to 16 weeks post-operatively.
Phakic patients with primary rhegmatogenous retinal detachment repair within 7 days of symptom onset, undergoing vitrectomy or vitrectomy with scleral buckle will be included. Patients will receive topical Netarsudil ophthalmic solution 0.02%: once per day, from time of diagnosis of retinal detachment to 16 weeks post-operatively.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts Eye and Ear Infirmary
Lead Sponsor
Citations
A Multi-Center Study on the Use of Rho-Kinase Inhibitor to ...
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 ...
Rho-kinase pathway inhibition for proliferative vitreoretinopathy
Netarsudil showed a significant (47.62% - 27.18%, p<0.002) anti-proliferative effect against C-PVR at concentrations between 2.5 and 0.1 μM at 48 h post- ...
Netarsudil for Retinal Detachment · Info for Participants
This trial is testing if the drug netarsudil can safely prevent scar tissue after surgery for a detached retina. It focuses on patients with a high risk of ...
Exploring the potential of rho kinase inhibitors in ...
In the retina, ROCK inhibitors reduce vascular leakage, inflammation and fibrosis in AMD, DR, and DME. •. Clinical trials show ROCK inhibitors are effective ...
5.
researchgate.net
researchgate.net/publication/341080471_Improving_outcomes_in_retinal_detachment_the_potential_role_of_rho-kinase_inhibitorsImproving outcomes in retinal detachment: the potential ...
Rod cell death in 4-h detachment: 10 mM fasudil injection reduces photoreceptor cell death (arrowheads). associated with retinal detachment.
Netarsudil for Retinal Detachment
This Phase 1 & 2 medical study run by Massachusetts Eye and Ear Infirmary is evaluating whether Netarsudil will have tolerable side effects & efficacy for ...
Trial | NCT05660447
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 ...
A real-world pharmacovigilance study of netarsudil based ...
This study aimed to explore the ocular and systemic safety of netarsudil through data mining the FDA Adverse Event Reporting System (FAERS) database.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.