ClinicalTrials.gg
CompletedNCT04752020Updated Mar 13, 2024

Netarsudil Use After Descemtorhexis Without Endothelial Keratoplasty

An Early Phase 1 interventional study of Netarsudil Ophthalmic in Fuchs' Endothelial Dystrophy, sponsored by Massachusetts Eye and Ear Infirmary. Completed at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2024-03-13.

Sponsored by Massachusetts Eye and Ear Infirmary · Early Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Jun 2023, 3 years 4 months ago, and no results have been posted to the registry.
Phase
Early Phase 1
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
40 Years and older
Sex
All
01

Study summary

This will be a prospective assessment of whether adjuvant Netarsudil use in patients undergoing Descemetorhexis without endothelial keratoplasty improves time to corneal clearance and post-operative central endothelial cell counts. The anticipated enrollment is 25 patients.

Read the detailed description

Subjects meeting inclusion criteria will be identified by Massachusetts Eye and Ear cornea surgeons during their pre-operative assessment and invited to participate in the study. Written informed consent will be obtained from the patient. The patients will then be added to a shared Epic patient list with a shared to-do column (outside of the patient record) indicating their subject ID and date of recruitment. All subjects will be asked to provide their best contact phone number which will be updated in the chart.

Upon obtaining informed consent, subjects will receive a bottle of Netarsudil from the Massachusetts Eye and Ear research pharmacy with post-operative instructions to use the drop once a day at bedtime starting on post-operative day 1 . Each patient will then receive regular, scheduled post-operative monitoring with a post-operative day 1 visit, post-operative week 1 visit, post-operative month 1 visit, and then every 2 month follow up for twelve months. Clinical examination, including best corrected visual acuity and intraocular pressure, will be recorded during every visit. Corneal topography and specular microscopy will be performed during the pre-operative assessment and during each bi-monthly visit in order to monitor for post-operative outcomes.

A retrospective chart review will be performed prior to new patient enrollment for patients who had previously had DWEK and did not receive a rho-kinase inhibitor. These patients will be included for pre-operative and post-operative vision, pachymetry, corneal topography results, and specular microscopy results with minimization of data acquisition as no informed consent can be obtained from these patients.

02

Conditions studied

  • Fuchs' Endothelial Dystrophy

Keywords

  • Descemetorhexis without endothelial keratoplasty
03

In context

Fuchs' Endothelial Dystrophy

92 studies on the registry are indexed under Fuchs' Endothelial Dystrophy; 27 are open to participants now.

This study's enrollment of 25 is below the median of 50 across 62 interventional studies indexed under Fuchs' Endothelial Dystrophy.

Browse Fuchs' Endothelial Dystrophy studies →

Lead sponsor

Massachusetts Eye and Ear Infirmary is the lead sponsor of 100 studies on the registry; 23 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 7 (54%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • Fuchs corneal dystrophy

Exclusion criteria

Exclusion Criteria:

  • Women of
  • Other corneal eye diseases
  • Non-compliance with netarsudil
  • Intolerance of netarsudil
Terms in these criteria, in plain language(1)

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.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Netarsudil use

    Patients will receive Netarsudil eye drops to use 1 drop nightly in the operative eye after DWEK surgery until corneal clearance

    Drug: Netarsudil Ophthalmic

Interventions

06

What researchers measure

Primary outcomes

  1. Change in central corneal pachymetry over time

    Corneal thickness on clinical examination and corneal topography

    Time frame: Measured at post-operative month one visit and then every 2 months for 1 year

  2. Change in endothelial cell count over time

    Central endothelial cell count by specular microscopy

    Time frame: Measured at post-operative month one visit and then every 2 months for 1 year

07

Study locations

1 site
  • Massachusetts Eye and Ear Infirmary
    Boston, Massachusetts 02127, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2021 to primary completion in Jun 2023, 27 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 2, 2021
First posted
Feb 12, 2021
StartActual
Mar 28, 2021
Primary completionActual
Jun 28, 2023
CompletionActual
Dec 30, 2023
Last update
Mar 13, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04752020
Responsible party
Emma C. Davies, MD (Principal investigator, Massachusetts Eye and Ear Infirmary) — Principal investigator
First posted
Feb 12, 2021
Start date
Mar 28, 2021
Primary completion
Jun 28, 2023
Completion
Dec 30, 2023
Last update
Mar 13, 2024

Study contacts

Emma Davies, MD
principal investigator · Massachusetts Eye and Ear Infirmary
Sila E Bal, MD, MPH
principal investigator · Massachusetts Eye and Ear Infirmary

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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