A Phase 2/3 interventional study of Netarsudil and Placebo in Fuchs' Endothelial Dystrophy, sponsored by Price Vision Group. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-06.
Sponsored by Price Vision Group · Phase 2/3, Interventional, and Treatment
Subjects with Fuchs dystrophy will be randomized to use either netarsudil or placebo eye drops to determine if the use of netarsudil accelerates migration of host peripheral corneal endothelial cells to restore the central endothelial cell layer.
Subjects with Fuchs endothelial dystrophy will have the central corneal endothelium and guttae-covered Descemet membrane surgically removed. Subjects will be randomized to use netarsudil or placebo eye drops once daily. Visual acuity, corneal clearing and central endothelial cell density will be monitored for the 3-month study duration.
92 studies on the registry are indexed under Fuchs' Endothelial Dystrophy; 27 are open to participants now.
This study's enrollment of 19 is below the median of 50 across 62 interventional studies indexed under Fuchs' Endothelial Dystrophy.
Browse Fuchs' Endothelial Dystrophy studies →Price Vision Group is the lead sponsor of 11 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Netarsudil ophthalmic solution 0.02%, dosed topically daily for the 3-month study duration or until 2 weeks after corneal clearing is complete, whichever occurs sooner
Drug: Netarsudil
Placebo eye drop, dosed topically daily for the 3-month study duration or until 2 weeks after corneal clearing is complete, whichever occurs sooner.
Drug: Placebo
netarsudil opthalmic solution 0.02%
Also known as: Rhopressa
Placebo eye drops
Corneal Clearing After Endothelial Removal for Treatment of Fuchs Dystrophy
The outcome measure was the percentage area of the cornea that remained edematous after removal of the endothelium. At the time of surgery, the surgeon recorded the lengths of the major and minor axes of the approximately circular area of endothelium removal; these values were used to calculate the area of stripping. At each postoperative exam, the examiner recorded the lengths of the major and minor axes of the edematous area; these values were used to calculate the area of edema. The percentage that remained edematous at 5 weeks was calculated by dividing the area of edema at 5 weeks by the area stripped.
Time frame: 5 weeks
| Milestone | Netarsudil | Placebo |
|---|---|---|
| Started | 10 | 9 |
| Completed | 10 | 8 |
| Not completed | 0 | 1 |
| Withdrew: Lack of efficacy | 0 | 1 |
The outcome measure was the percentage area of the cornea that remained edematous after removal of the endothelium. At the time of surgery, the surgeon recorded the lengths of the major and minor axes of the approximately circular area of endothelium removal; these values were used to calculate the area of stripping. At each postoperative exam, the examiner recorded the lengths of the major and minor axes of the edematous area; these values were used to calculate the area of edema. The percentage that remained edematous at 5 weeks was calculated by dividing the area of edema at 5 weeks by the area stripped.
| percentage of area stripped | Netarsudil | Placebo |
|---|---|---|
| Corneal Clearing After Endothelial Removal for Treatment of Fuchs Dystrophy | 42 ± 45 | 43 ± 49 |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Netarsudil | 0/10 (0%) | 0/10 (0%) | 3/10 (30%) |
| Placebo | 0/9 (0%) | 0/9 (0%) | 3/9 (33.3%) |
| Event | Netarsudil | Placebo |
|---|---|---|
| eye discomfortEye disorders | 2/10 | 3/9 |
| cystoid macular edemaEye disorders | 1/10 | 0/9 |
| microcystic corneal epithelial bullaeEye disorders | 1/10 | 0/9 |
| Age, Continuous(years) | Netarsudil | Placebo | Total |
|---|---|---|---|
| Mean | 65 ± 10 | 58 ± 17 | 62 ± 14 |
| Sex: Female, Male(Participants) | Netarsudil | Placebo | Total |
|---|---|---|---|
| Female | 10 | 8 | 18 |
| Male | 0 | 1 | 1 |
| Race and Ethnicity Not Collected(Participants) | Netarsudil | Placebo | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Netarsudil | Placebo | Total |
|---|---|---|---|
| United States | 10 | 9 | 19 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is terminated, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Netarsudil
Fuchs' Endothelial Dystrophy →
Price Vision Group