Corneal EdemaPhase 2FuchsNCT04498169

A Phase 2 Study Evaluating the Safety and Efficacy of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy

A Phase 2 study testing Netarsudil Ophthalmic in people with Corneal Edema, run by Aerie Pharmaceuticals at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Two different dosing regimens (QD and BID) of netarsudil will be studied to evaluate their efficacy in reducing or resolving corneal edema in subjects with FCD. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Corneal Edema
What is being tested?: Netarsudil Ophthalmic
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 12 sitesUnited States
Study dates: 17 Sep 2020to 11 Aug 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adults aged 18 years or older
Documented diagnosis of FCD
Evidence of central corneal edema, in at least one eye, at the Screening and Baseline Visit, in the eligible eye(s)
Reduced BCVA secondary to central corneal edema, at Screening and Baseline, in the eligible eye(s)

Who cannot join

FCD so advanced that, in the opinion of the Investigator, surgery would likely be required in the study eligible eye(s) within the study period
Clinically significant ocular disease (other than FCD) or trauma in the eligible eye(s) which could interfere with study interpretation
History of ocular surgery within 6 months of the Screening Visit, or any prior corneal refractive surgery in the eligible eye(s)

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

Chu Vision Institute
Bloomington, Minnesota, 55420
Cincinnati Eye Institute
Edgewood, Kentucky, 41017
Orange County Ophthalmology
Garden Grove, California, 92843
Houston Eye Associates
Houston, Texas, 77025
Harvard Eye Associates
Laguna Hills, California, 92653
Minnesota Eye Care
Minnetonka, Minnesota, 55305
Virginia Eye Consultants
Norfolk, Virginia, 23502
Vance Thompson Vision
Sioux Falls, South Dakota, 57108
Advance Eye Associates
South Dartmouth, Massachusetts, 02748
Ophthalmology Associates
St Louis, Missouri, 63131
Vance Thompson Vision
West Fargo, North Dakota, 58078
Comprehensive Eye Care
Westerville, Ohio, 43082

Other trials in United States

About this study

Official title: A Randomized, Open-Label, Parallel-Group Study to Evaluate the Safety and Efficacy of Two Dosing Regimens of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy

Two different dosing regimens (QD and BID) of netarsudil will be studied to evaluate their efficacy in reducing or resolving corneal edema in subjects with FCD.

Conditions: Corneal Edema
Being tested: Netarsudil Ophthalmic
Keywords: Corneal Edema, Fuchs Corneal Dystrophy, Netarsudil Ophthalmic Solution
Medical subject headings: Corneal Edema, Fuchs' Endothelial Dystrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Netarsudil OphthalmicDrug
Also called Rhopressa®
Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution
Netarsudil OphthalmicDrug
Also called Rhopressa®
Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution

Study groups in NCT04498169
Study group	Role	What they receive
Once Daily Netarsudil Ophthalmic Solution	Experimental	One drop of Netarsudil 0.02% ophthalmic solution in the study eye in the evening for an 8 week period in up to 20 subjects. Receives: Drug: Netarsudil Ophthalmic
Twice Daily Netarsudil Ophthalmic Solution	Experimental	One drop of Netarsudil 0.02% ophthalmic solution in the study eye in the morning and in the evening for an 8 week period in up to 20 subjects. Receives: Drug: Netarsudil Ophthalmic

What is being measured

The primary outcome is the main question the study is designed to answer.

Central Corneal Thickness (CCT)
Mean change from baseline in CCT by ultrasound pachymetry
Measured: Baseline & 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Sep 202011 Aug 2021

First posted4 Aug 2020
Study start17 Sep 2020
Primary completion11 Aug 2021
Study completion11 Aug 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Corneal EdemaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04498169
Sponsor's protocol ID: AR-13324-CS210
Acronym: Fuchs
Status last verified: Aug 2022
First submitted: 31 Jul 2020
Last updated: 15 Sep 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Lindstrom RL, Lewis AE, Holland EJ, Sheppard JD, Hovanesian JA, Senchyna M, Hollander DA. Phase 2, Randomized, Open-Label Parallel-Group Study of Two Dosing Regimens of Netarsudil for the Treatment of Corneal Edema Due to Fuchs Corneal Dystrophy. J Ocul Pharmacol Ther. 2022 Dec;38(10):657-663. doi: 10.1089/jop.2022.0069. Epub 2022 Nov 3.
PubMed 36327101

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
Study of EO2002 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction
Corneal Edema, Fuchs
Active, not recruitingPhase 3
AURN001 Efficacy in Participants With Corneal Edema Secondary to Corneal Endothelial Dysfunction
Corneal Edema, Corneal Endothelial Dysfunction
Active, not recruiting
The Belgian Endothelial Surgical Transplant of the Cornea
Corneal Edema, Corneal Endothelial Disorder
Enrolling by invitationObservational study
The Effect of Topical Rho-kinase Inhibitors on Corneas of Patients With Fuchs Endothelial Corneal Dystrophy
Fuchs Endothelial Corneal Dystrophy, Cataract
Recruiting
Plasma Rich in Growth Factors in Corneal Endothelial Transplantation
Fuchs' Endothelial Dystrophy, Corneal Edema

All Corneal Edema trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-Label, Parallel-Group Study to Evaluate the Safety and Efficacy of Two Dosing Regimens of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy
ClinicalTrials.gov ID: NCT04498169
Acronym / sponsor ID: Fuchs / AR-13324-CS210
Conditions: Corneal Edema
Keywords: Corneal Edema, Fuchs Corneal Dystrophy, Netarsudil Ophthalmic Solution
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Aerie PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 17 Sep 2020 (actual)
Primary completion: 11 Aug 2021 (actual)
Study completion: 11 Aug 2021 (actual)
First posted: 4 Aug 2020 (actual)
Results: Posted 1 Sep 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Two different dosing regimens (QD and BID) of netarsudil will be studied to evaluate their efficacy in reducing or resolving corneal edema in subjects with FCD.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Once Daily Netarsudil Ophthalmic Solution	Experimental	Drug: Netarsudil OphthalmicOne drop of Netarsudil 0.02% ophthalmic solution in the study eye in the evening for an 8 week period in up to 20 subjects.
Twice Daily Netarsudil Ophthalmic Solution	Experimental	Drug: Netarsudil OphthalmicOne drop of Netarsudil 0.02% ophthalmic solution in the study eye in the morning and in the evening for an 8 week period in up to 20 subjects.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Adults aged 18 years or older
Documented diagnosis of FCD
Evidence of central corneal edema, in at least one eye, at the Screening and Baseline Visit, in the eligible eye(s)
Reduced BCVA secondary to central corneal edema, at Screening and Baseline, in the eligible eye(s)

Key exclusion criteria (3 listed)

FCD so advanced that, in the opinion of the Investigator, surgery would likely be required in the study eligible eye(s) within the study period
Clinically significant ocular disease (other than FCD) or trauma in the eligible eye(s) which could interfere with study interpretation
History of ocular surgery within 6 months of the Screening Visit, or any prior corneal refractive surgery in the eligible eye(s)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Netarsudil OphthalmicAlso: Rhopressa®Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution	Drug	Once Daily Netarsudil Ophthalmic Solution
Netarsudil OphthalmicAlso: Rhopressa®Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution	Drug	Twice Daily Netarsudil Ophthalmic Solution

Primary outcome

Central Corneal Thickness (CCT)
Time frame: Baseline & 4 weeks
Mean change from baseline in CCT by ultrasound pachymetry

Results and safety

Results posted to the registry on 1 Sep 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Once Daily Netarsudil Ophthalmic Solution	20	19
Twice Daily Netarsudil Ophthalmic Solution	20	19

Primary outcome: Central Corneal Thickness (CCT)

Time frame: Baseline & 4 weeks. Mean (Standard Deviation). Unit: µm

Measure	Once Daily Netarsudil Ophthalmic Solution n = 20	Twice Daily Netarsudil Ophthalmic Solution n = 20
Value	-28.4 (35.72)	-20.1 (39.12)

Once Daily Netarsudil Ophthalmic Solution vs Twice Daily Netarsudil Ophthalmic Solution: p = 0.0021, One-sample t-test (within group)

Population analysed: Modified Intent-to-Treat Population

Adverse events

Time frame: Adverse events were documented from the time of signing the informed consent until the last study visit for each participant. This was a period of approximately 8 weeks (56 days) for participants who completed the full study duration. For AEs ongoing at the time of study completion, the ongoing AE was followed-up and the participant was provided appropriate medical care until the event resolved or stabilized, the participant was lost to follow-up, or there was other resolution to the event.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Once Daily Netarsudil Ophthalmic Solution	0 of 20 (0%)	5 of 20 (25%)	0 of 20
Twice Daily Netarsudil Ophthalmic Solution	1 of 20 (5%)	7 of 20 (35%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36327101Lindstrom RL, Lewis AE, Holland EJ, Sheppard JD, Hovanesian JA, Senchyna M, Hollander DA. Phase 2, Randomized, Open-Label Parallel-Group Study of Two Dosing Regimens of Netarsudil for the Treatment of Corneal Edema Due to Fuchs Corneal Dystrophy. J Ocul Pharmacol Ther. 2022 Dec;38(10):657-663. doi: 10.1089/jop.2022.0069. Epub 2022 Nov 3.
Individual participant dataSharing planned: No

Related trials for Corneal Edema

RecruitingPhase 2
Study of EO2002 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction
Corneal Edema, Fuchs
Active, not recruitingPhase 3
AURN001 Efficacy in Participants With Corneal Edema Secondary to Corneal Endothelial Dysfunction
Corneal Edema, Corneal Endothelial Dysfunction
Active, not recruiting
The Belgian Endothelial Surgical Transplant of the Cornea
Corneal Edema, Corneal Endothelial Disorder
Enrolling by invitationObservational study
The Effect of Topical Rho-kinase Inhibitors on Corneas of Patients With Fuchs Endothelial Corneal Dystrophy
Fuchs Endothelial Corneal Dystrophy, Cataract
Recruiting
Plasma Rich in Growth Factors in Corneal Endothelial Transplantation
Fuchs' Endothelial Dystrophy, Corneal Edema

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michelle Senchyna, Ph.D. study director

Aerie Pharmaceuticals Inc.

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Netarsudil Ophthalmic in people with Corneal Edema, run by Aerie Pharmaceuticals at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Central Corneal Thickness (CCT) (time frame: Baseline & 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04498169, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2022.