Fuchs' Endothelial DystrophyPhase 4NCT03249337
Glanatec(R) for Descemet Stripping in Fuch's Endothelial Dystrophy
A Phase 4 study testing Ripasudil hydrochloride hydrate 0.4% ophthalmic solution in people with Fuchs' Endothelial Dystrophy, run by Marian Macsai, MD at 1 site in United States.
Trial summary
In brief, the objective of this study is to investigate whether the drug Glanatec ® which is approved in Japan for glaucoma and ocular hypertension, can be used in patients with Fuchs endothelial dystrophy who have had a descemet stripping procedure without endothelial keratoplasty. Read more about this study
- Who is it for?
- Ages 18 to 91 years
- Conditions the study is for
- Fuchs' Endothelial Dystrophy
- What is being tested?
- Ripasudil hydrochloride hydrate 0.4% ophthalmic solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2017to Dec 2021
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 to 91 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Ability to understand read and sign the informed consent form.
- Age between 30 and <91 years
- Ability to understand and follow instructions and study procedures
- Willingness to comply with all study procedures and be available for the duration of the study
- Ability to apply eye drop medication and willing to adhere to study medication regimen
- Diagnosed with Fuchs dystrophy (clinically and on confocal microscopy) by the study investigator.
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- Pseudophakic FED with posterior capsule supported, suture-fixated, or sulcus-supported posterior chamber intraocular lens.
- Fuchs dystrophy grades 2-4 on the Krachmer grading scale
- Presence of central guttae deemed by the investigator to be the chief cause of visual symptoms, rather than cataract or corneal stromal edema
- Clear peripheral cornea with an endothelial cell count >1000 cells/mm2 on specular microscopy
- Best corrected visual acuity in the study eye is 20/40 or worse at study enrollment
- The patient is dissatisfied with current vision
- The patient is otherwise to be offered a corneal graft
- For females with reproductive potential, willingness to use highly effective contraception (e.g., hormonal contraception, barrier contraception, intrauterine device, or abstinence).
- Indication for surgery may include cataract extraction and posterior chamber intraocular lens implantation
Who cannot join
- • Uncontrolled glaucoma (IOP >25 mmHg)
- Presence of secondary corneal pathology such as infective or autoimmune keratitis
- Advanced corneal stromal edema defined as the presence of haze, bullae, or DM folds on slit-lamp biomicroscopy
- History of herpes simplex virus or cytomegalovirus keratitis
- Prior endothelial keratoplasty
- Aphakic in study eye.
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- Allergy to any component of the Ripasudil hydrochloride hydrate 0.4% that will be used in the course of the study
- For women of child-bearing potential: Pregnant or lactating, or planning to become pregnant within the next 6 months.
- Any other ocular condition that, in the opinion of the investigator, may preclude the subject from study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NorthShore University HealthSystem
Glenview, Illinois, 60026
Duanny Alva, MPH, 847-570-1783, dalva@northore.org
Marian Macsai, MD
About this study
Official title: A Pilot Study For Efficacy And Safety Of Glanatec® Opthalmic Solution 0.4% On Corneal Edema And Endothelial Cell Counts In Subjects With Fuchs Endothelial Dystrophy Undergoing Descemet Stripping Without Endothelial Keratoplasty
In brief, the objective of this study is to investigate whether the drug Glanatec ® which is approved in Japan for glaucoma and ocular hypertension, can be used in patients with Fuchs endothelial dystrophy who have had a descemet stripping procedure without endothelial keratoplasty. While some limited data exists as a proof of concept in in vitro or animal studies, and Glanatec® has been successfully used in a recently published case series for this indication, there is insufficient data to show that this drug can be effectively used for corneal cell clearing while maintaining patient safety.
The goal of the study is to provide sufficient proof of concept for the use of this drug in patients with FED whose only treatment alternative is to undergo corneal transplant.
- Conditions
- Fuchs' Endothelial Dystrophy
- Being tested
- Ripasudil hydrochloride hydrate 0.4% ophthalmic solution
- 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.
Ripasudil hydrochloride hydrate 0.4% ophthalmic solutionDrug
Also called Glanatec
the ophthalmic solution will be administered three or six per times per day in the eye designated as the "Study Eye" upon study enrollment
| Study group | Role | What they receive |
|---|---|---|
| Glanatec(R) 3 times a day | Active comparator | Not described Receives: Drug: Ripasudil hydrochloride hydrate 0.4% ophthalmic solution |
| Glanatec (R) 6 times a day | Active comparator | Not described Receives: Drug: Ripasudil hydrochloride hydrate 0.4% ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal Clearing
The first primary aim of this study is to examine whether Glanatec® administered three or six times daily significantly increases corneal clearing at 12 months versus baseline in patients with Fuchs endothelial dystrophy (FED) undergoing Descemet stripping
Measured: 12 months
pachymetry measurement
The second primary aim of this study is to examine whether Glanatec® administered three or six times daily significantly reduces the pachymetry measurement at 12 months versus baseline in patients with Fuchs endothelial dystrophy (FED) undergoing Descemet stripping.
Measured: 12 months
Secondary outcomes (1)
Visual Acuity
The secondary aim of this study is to examine whether Glanatec® administered three or six times daily affects best corrected visual acuity at 12 months (measured by Snellen lines) as compared to baseline, patients with Fuchs endothelial dystrophy (FED) undergoing Descemet stripping.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start6 Dec 2017
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marian Macsai, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marian Macsai, MD, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03249337
- Sponsor's protocol ID
- EH17-320
- Status last verified
- Aug 2021
- First submitted
- 10 Aug 2017
- Last updated
- 11 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study For Efficacy And Safety Of Glanatec® Opthalmic Solution 0.4% On Corneal Edema And Endothelial Cell Counts In Subjects With Fuchs Endothelial Dystrophy Undergoing Descemet Stripping Without Endothelial Keratoplasty
- ClinicalTrials.gov ID
- NCT03249337
- Acronym / sponsor ID
- EH17-320
- Conditions
- Fuchs' Endothelial Dystrophy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Marian Macsai, MDUniversity, hospital or other
- Study start
- 6 Dec 2017 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 15 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In brief, the objective of this study is to investigate whether the drug Glanatec ® which is approved in Japan for glaucoma and ocular hypertension, can be used in patients with Fuchs endothelial dystrophy who have had a descemet stripping procedure without endothelial keratoplasty. While some limited data exists as a proof of concept in in vitro or animal studies, and Glanatec® has been successfully used in a recently published case series for this indication, there is insufficient data to show that this drug can be effectively used for corneal cell clearing while maintaining patient safety.
The goal of the study is to provide sufficient proof of concept for the use of this drug in patients with FED whose only treatment alternative is to undergo corneal transplant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glanatec(R) 3 times a day | Active comparator | Drug: Ripasudil hydrochloride hydrate 0.4% ophthalmic solution |
| Glanatec (R) 6 times a day | Active comparator | Drug: Ripasudil hydrochloride hydrate 0.4% ophthalmic solution |
Who may qualify
- Ages
- 18 to 91 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- • Ability to understand read and sign the informed consent form.
Key exclusion criteria (9 listed)
- • Uncontrolled glaucoma (IOP >25 mmHg)
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 |
|---|---|---|
| Ripasudil hydrochloride hydrate 0.4% ophthalmic solutionAlso: Glanatecthe ophthalmic solution will be administered three or six per times per day in the eye designated as the "Study Eye" upon study enrollment | Drug | Glanatec (R) 6 times a day, Glanatec(R) 3 times a day |
Primary outcome
Corneal Clearing
Time frame: 12 months
The first primary aim of this study is to examine whether Glanatec® administered three or six times daily significantly increases corneal clearing at 12 months versus baseline in patients with Fuchs endothelial dystrophy (FED) undergoing Descemet stripping
pachymetry measurement
Time frame: 12 months
The second primary aim of this study is to examine whether Glanatec® administered three or six times daily significantly reduces the pachymetry measurement at 12 months versus baseline in patients with Fuchs endothelial dystrophy (FED) undergoing Descemet stripping.
1 secondary outcome
Visual Acuity
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
- Individual participant dataSharing planned: No
Related trials for Fuchs' Endothelial Dystrophy
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ripasudil hydrochloride hydrate 0.4% ophthalmic solution in people with Fuchs' Endothelial Dystrophy, run by Marian Macsai, MD 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 15 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: looking for participants now, as of the sponsor's last update on 11 Aug 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Duanny Alva, MPH (847-570-1783, dalva@northshore.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal Clearing (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Aug 2021.