Fuchs Endothelial DystrophyPhase 2/3NCT04051463
Rhopressa for Corneal Edema Associated With Fuchs Dystrophy
A Phase 2/3 study testing Netarsudil Ophthalmic Solution in people with Fuchs Endothelial Dystrophy, run by Price Vision Group at 1 site in United States.
Trial summary
The study objective is to determine whether use of Rhopressa improves the ability of corneal endothelial cells to maintain appropriate corneal hydration in patients with Fuchs endothelial corneal dystrophy (FECD), which could help delay or prevent the need for a corneal transplant. 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 Ophthalmic Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2019to 1 Jul 2020
- 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
- At least 18 years of age
- Male or female patient diagnosed with FECD and corneal edema evident by slit lamp exam and/or corneal tomography.
- Patient is able and willing to administer eye drops.
- Patient 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.
- 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™ Can Ameliorate Corneal Edema Associated With Fuchs Dystrophy
The study objective is to determine whether use of Rhopressa improves the ability of corneal endothelial cells to maintain appropriate corneal hydration in patients with Fuchs endothelial corneal dystrophy (FECD), which could help delay or prevent the need for a corneal transplant.
- Conditions
- Fuchs Endothelial Dystrophy
- Being tested
- Netarsudil Ophthalmic Solution, 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.
Netarsudil Ophthalmic SolutionDrug
Also called Rhopressa
Netarsudil eye drops instilled once daily
PlaceboDrug
Also called Rhopressa vehicle without active ingredient
Placebo eye drops instilled once daily
| Study group | Role | What they receive |
|---|---|---|
| Netarsudil | Active comparator | A drop of Netarsudil 0.02% ophthalmic solution will be instilled into both eyes once daily at night. Receives: Drug: Netarsudil Ophthalmic Solution |
| Placebo | Placebo comparator | A placebo eye drop, consisting of the vehicle for netarsudil ophthalmic solution without the active ingredient, will be instilled into both eyes once daily at night. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Central Corneal Thickness
Central corneal thickness at 1 month after randomization minus central corneal thickness at baseline
Measured: 1 month
Secondary outcomes (1)
Change in Corrected Distance Visual Acuity (CDVA)
Change in CDVA (lines read on the eye chart at 3 months minus lines read at baseline)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start5 Aug 2019
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
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 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
- 29 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
- NCT04051463
- Sponsor's protocol ID
- 2019-007
- Status last verified
- Sep 2021
- First submitted
- 7 Aug 2019
- Last updated
- 19 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Price MO, Price FW Jr. Randomized, Double-Masked, Pilot Study of Netarsudil 0.02% Ophthalmic Solution for Treatment of Corneal Edema in Fuchs Dystrophy. Am J Ophthalmol. 2021 Jul;227:100-105. doi: 10.1016/j.ajo.2021.03.006. Epub 2021 Mar 15.
PubMed 33737034
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study to Determine Whether Use of Rhopressa™ Can Ameliorate Corneal Edema Associated With Fuchs Dystrophy
- ClinicalTrials.gov ID
- NCT04051463
- Acronym / sponsor ID
- 2019-007
- Conditions
- Fuchs Endothelial Dystrophy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Price Vision GroupIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 9 Aug 2019 (actual)
- Results
- Posted 24 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study objective is to determine whether use of Rhopressa improves the ability of corneal endothelial cells to maintain appropriate corneal hydration in patients with Fuchs endothelial corneal dystrophy (FECD), which could help delay or prevent the need for a corneal transplant.
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 | Active comparator | Drug: Netarsudil Ophthalmic SolutionA drop of Netarsudil 0.02% ophthalmic solution will be instilled into both eyes once daily at night. |
| Placebo | Placebo comparator | Drug: PlaceboA placebo eye drop, consisting of the vehicle for netarsudil ophthalmic solution without the active ingredient, will be instilled into both eyes once daily at night. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years of age
- Male or female patient diagnosed with FECD and corneal edema evident by slit lamp exam and/or corneal tomography.
- Patient is able and willing to administer eye drops.
- Patient is able to comprehend and has signed the Informed Consent form.
Key exclusion criteria (8 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.
- History of non-compliance with using prescribed medication.
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 Ophthalmic SolutionAlso: RhopressaNetarsudil eye drops instilled once daily | Drug | Netarsudil |
| PlaceboAlso: Rhopressa vehicle without active ingredientPlacebo eye drops instilled once daily | Drug | Placebo |
Primary outcome
Change in Central Corneal Thickness
Time frame: 1 month
Central corneal thickness at 1 month after randomization minus central corneal thickness at baseline
1 secondary outcome
Change in Corrected Distance Visual Acuity (CDVA)
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33737034Price MO, Price FW Jr. Randomized, Double-Masked, Pilot Study of Netarsudil 0.02% Ophthalmic Solution for Treatment of Corneal Edema in Fuchs Dystrophy. Am J Ophthalmol. 2021 Jul;227:100-105. doi: 10.1016/j.ajo.2021.03.006. Epub 2021 Mar 15.
- Individual participant dataSharing planned: No
Related trials for Fuchs Endothelial Dystrophy
Active, not recruitingPhase 3
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RecruitingObservational study
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
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The Belgian Endothelial Surgical Transplant of the Cornea
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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 Ophthalmic Solution 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 4 inclusion and 8 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 19 Oct 2021. 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 24 Sep 2021). 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?
Change in Central Corneal Thickness (time frame: 1 month). 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 NCT04051463, 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 19 Oct 2021.