Fuchs' Endothelial DystrophyPhase 2/3NCT03971357
Trial of Netarsudil for Acceleration of Corneal Endothelial Restoration
A Phase 2/3 study testing Netarsudil in people with Fuchs' Endothelial Dystrophy, run by Price Vision Group at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fuchs' Endothelial Dystrophy
- What is being tested?
- Netarsudil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2019to 26 Aug 2021
- Phase
- Phase 2/3
- 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
- Male or female patient at least 18 years of age and of any race or ethnicity who is undergoing Descemet stripping only for Fuchs dystrophy
- Is able and willing to administer eye drops
- Is able to comprehend and has signed the Informed Consent form.
Who cannot join
- Active intraocular inflammation
- Corneal ulceration, keratitis, or conjunctivitis
- Known sensitivity to any of the ingredients in the study medications
- Abnormal eyelid function
- History of herpetic keratitis
- History of non-compliance with using prescribed medication
Show all 9Show fewer
- Current or planned pregnancy within the study duration
- Concurrent involvement or participation in another randomized clinical trial within 30 days prior to enrollment in this study
- Any ocular or systemic condition (i.e., UNCONTROLLED systemic disease) or situation which in the investigator's opinion may put the patient at significant risk, confound the study results, or interfere significantly with the patient's participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Study to Determine Whether Use of Rhopressa™ Accelerates Corneal Clearing After Removal of Descemet Membrane for Treatment of Fuchs Dystrophy
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.
Read the detailed description
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.
- Conditions
- Fuchs' Endothelial Dystrophy
- Being tested
- Netarsudil, Placebo
- Medical subject headings
- Fuchs' Endothelial Dystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NetarsudilDrug
Also called Rhopressa
netarsudil opthalmic solution 0.02%
PlaceboDrug
Placebo eye drops
| Study group | Role | What they receive |
|---|---|---|
| Netarsudil | Experimental | 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 Receives: Drug: Netarsudil |
| Placebo | Placebo comparator | Placebo eye drop, dosed topically daily for the 3-month study duration or until 2 weeks after corneal clearing is complete, whichever occurs sooner. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start22 Jul 2019
- Primary completion26 Aug 2021
- Study completion26 Aug 2021
Why it stopped: variance of outcome measures was substantially greater than anticipated in the statistical plan
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 (5)Papers the sponsor has linked to this study.
- Other trials for Fuchs' Endothelial DystrophyStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Price Vision Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francis W Price, Jr, MD, Principal investigator, Price Vision Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03971357
- Sponsor's protocol ID
- 2018-009
- Status last verified
- Aug 2021
- First submitted
- 30 May 2019
- Last updated
- 6 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arbelaez JG, Price MO, Price FW Jr. Long-term follow-up and complications of stripping descemet membrane without placement of graft in eyes with Fuchs endothelial dystrophy. Cornea. 2014 Dec;33(12):1295-9. doi: 10.1097/ICO.0000000000000270.
PubMed 25299425Moloney G, Petsoglou C, Ball M, Kerdraon Y, Hollhumer R, Spiteri N, Beheregaray S, Hampson J, D'Souza M, Devasahayam RN. Descemetorhexis Without Grafting for Fuchs Endothelial Dystrophy-Supplementation With Topical Ripasudil. Cornea. 2017 Jun;36(6):642-648. doi: 10.1097/ICO.0000000000001209.
PubMed 28476048Borkar DS, Veldman P, Colby KA. Treatment of Fuchs Endothelial Dystrophy by Descemet Stripping Without Endothelial Keratoplasty. Cornea. 2016 Oct;35(10):1267-73. doi: 10.1097/ICO.0000000000000915.
PubMed 27310885Soh YQ, Mehta JS. Regenerative Therapy for Fuchs Endothelial Corneal Dystrophy. Cornea. 2018 Apr;37(4):523-527. doi: 10.1097/ICO.0000000000001518.
PubMed 29384808Wacker K, Baratz KH, Bourne WM, Patel SV. Patient-Reported Visual Disability in Fuchs' Endothelial Corneal Dystrophy Measured by the Visual Function and Corneal Health Status Instrument. Ophthalmology. 2018 Dec;125(12):1854-1861. doi: 10.1016/j.ophtha.2018.06.018. Epub 2018 Aug 10.
PubMed 30104038
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study to Determine Whether Use of Rhopressa™ Accelerates Corneal Clearing After Removal of Descemet Membrane for Treatment of Fuchs Dystrophy
- ClinicalTrials.gov ID
- NCT03971357
- Acronym / sponsor ID
- 2018-009
- Conditions
- Fuchs' Endothelial Dystrophy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: variance of outcome measures was substantially greater than anticipated in the statistical plan
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Price Vision GroupIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- 26 Aug 2021 (actual)
- Study completion
- 26 Aug 2021 (actual)
- First posted
- 3 Jun 2019 (actual)
- Results
- Posted 6 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Netarsudil | Experimental | Drug: NetarsudilNetarsudil 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 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo eye drop, dosed topically daily for the 3-month study duration or until 2 weeks after corneal clearing is complete, whichever occurs sooner. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female patient at least 18 years of age and of any race or ethnicity who is undergoing Descemet stripping only for Fuchs dystrophy
- Is able and willing to administer eye drops
- Is able to comprehend and has signed the Informed Consent form.
Key exclusion criteria (9 listed)
- Active intraocular inflammation
- Corneal ulceration, keratitis, or conjunctivitis
- Known sensitivity to any of the ingredients in the study medications
- Abnormal eyelid function
- History of herpetic keratitis
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 |
|---|---|---|
| NetarsudilAlso: Rhopressanetarsudil opthalmic solution 0.02% | Drug | Netarsudil |
| PlaceboPlacebo eye drops | Drug | Placebo |
Primary outcome
Corneal Clearing After Endothelial Removal for Treatment of Fuchs Dystrophy
Time frame: 5 weeks
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25299425Arbelaez JG, Price MO, Price FW Jr. Long-term follow-up and complications of stripping descemet membrane without placement of graft in eyes with Fuchs endothelial dystrophy. Cornea. 2014 Dec;33(12):1295-9. doi: 10.1097/ICO.0000000000000270.
- Background: PubMed 28476048Moloney G, Petsoglou C, Ball M, Kerdraon Y, Hollhumer R, Spiteri N, Beheregaray S, Hampson J, D'Souza M, Devasahayam RN. Descemetorhexis Without Grafting for Fuchs Endothelial Dystrophy-Supplementation With Topical Ripasudil. Cornea. 2017 Jun;36(6):642-648. doi: 10.1097/ICO.0000000000001209.
- Background: PubMed 27310885Borkar DS, Veldman P, Colby KA. Treatment of Fuchs Endothelial Dystrophy by Descemet Stripping Without Endothelial Keratoplasty. Cornea. 2016 Oct;35(10):1267-73. doi: 10.1097/ICO.0000000000000915.
- Background: PubMed 29384808Soh YQ, Mehta JS. Regenerative Therapy for Fuchs Endothelial Corneal Dystrophy. Cornea. 2018 Apr;37(4):523-527. doi: 10.1097/ICO.0000000000001518.
- Background: PubMed 30104038Wacker K, Baratz KH, Bourne WM, Patel SV. Patient-Reported Visual Disability in Fuchs' Endothelial Corneal Dystrophy Measured by the Visual Function and Corneal Health Status Instrument. Ophthalmology. 2018 Dec;125(12):1854-1861. doi: 10.1016/j.ophtha.2018.06.018. Epub 2018 Aug 10.
- Individual participant dataSharing planned: No
Related trials for Fuchs' Endothelial Dystrophy
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Study of EO2002 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction
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RecruitingObservational study
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
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DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy
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Active, not recruiting
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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.
Francis W Price, Jr, MD principal investigator
Price Vision Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Netarsudil in people with Fuchs' Endothelial Dystrophy, run by Price Vision Group at 1 site 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 3 inclusion and 9 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: stopped early, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 6 Feb 2023). 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?
Corneal Clearing After Endothelial Removal for Treatment of Fuchs Dystrophy (time frame: 5 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 NCT03971357, which also lists 5 linked publications.
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 6 Feb 2023.