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Rho Kinase Inhibitor
Netarsudil Eye Drops for Fuchs' Dystrophy
Phase < 1
Waitlist Available
Led By Emma Davies, MD
Research Sponsored by Massachusetts Eye and Ear Infirmary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at post-operative month one visit and then every 2 months for 1 year
Awards & highlights
Approved for 5 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This trial will look at whether a certain medication can improve healing time and cell counts after a specific eye surgery.
Eligible Conditions
- Fuchs' Dystrophy
- Corneal Endothelial Dystrophy
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ measured at post-operative month one visit and then every 2 months for 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at post-operative month one visit and then every 2 months for 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in central corneal pachymetry over time
Change in endothelial cell count over time
Side effects data
From 2021 Phase 2 trial • 40 Patients • NCT0449816915%
Corneal verticillata
10%
Conjunctival hypaeremia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Once Daily Netarsudil Ophthalmic Solution
Twice Daily Netarsudil Ophthalmic Solution
Awards & Highlights
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Netarsudil useExperimental Treatment1 Intervention
Patients will receive Netarsudil eye drops to use 1 drop nightly in the operative eye after DWEK surgery until corneal clearance
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Netarsudil
FDA approved
Find a Location
Who is running the clinical trial?
Massachusetts Eye and Ear InfirmaryLead Sponsor
109 Previous Clinical Trials
12,658 Total Patients Enrolled
Emma Davies, MDPrincipal InvestigatorMassachusetts Eye and Ear Infirmary
Sila E Bal, MD, MPHPrincipal InvestigatorMassachusetts Eye and Ear Infirmary
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Women who could become pregnant.You have any other eye diseases affecting your cornea.
Research Study Groups:
This trial has the following groups:- Group 1: Netarsudil use
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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