Fuchs Endothelial DystrophyPhase 2NCT03813056
Ripasudil for Enhanced Corneal Clearing Following Descemet Membrane Endothelial Keratoplasty in Fuchs' Dystrophy
A Phase 2 study testing Glanatec, Optive, Ophthalmic Solution and Descemet Membrane Endothelial Keratoplasty in people with Fuchs Endothelial Dystrophy, run by Michael D. Straiko, MD at 1 site in United States.
Trial summary
Recently, published literature has reported that performing a descemetorhexis in combination with topical Rho kinase (ROCK) inhibitor therapy was successful in clearing edematous corneas in patients with Fuchs Endothelial Corneal Dystrophy. Read more about this study
- Who is it for?
- Ages 30 to 99 years
- Conditions the study is for
- Fuchs Endothelial Dystrophy
- What is being tested?
- Glanatec, Optive, Ophthalmic Solution and Descemet Membrane Endothelial Keratoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2019to 1 Feb 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 30 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed clinically with Fuchs endothelial corneal dystrophy by the study investigator.
- Phakic or pseudophakic with posterior capsule supported, suture-fixated, or sulcus-supported posterior chamber intraocular lens.
- Fuchs dystrophy grades 2-5 on the Krachmer grading scale.
- Presence of central guttae and/or stromal edema being the primary cause of decreased vision.
- The peripheral cornea to the central 6mm is devoid of guttata changes.
- Best corrected visual acuity in the study eye is 20/40 or worse with glare testing at study enrollment.
Who cannot join
- Uncontrolled glaucoma (IOP >25 mmHg).
- Presence of secondary corneal pathology such as infective or autoimmune keratitis.
- Advanced corneal stromal edema with bullae on slit-lamp biomicroscopy.
- History of herpes simplex virus or cytomegalovirus keratitis.
- Prior penetrating keratoplasty.
- Aphakic in study eye.
- Allergy to any component of the Ripasudil hydrochloride hydrate 0.4% that will be used in the course of the study.
- Tubes or trabeculectomy from prior glaucoma surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Devers Eye Institute
Portland, Oregon, 97210
Alex J Bauer, B.S., 503-413-8377, alex@visiongift.org
About this study
Official title: A Phase II, Interventional, Double-blind, Single-center Study of the Effects of Ripasudil on Cornea Clearing After Descemet Membrane Endothelial Keratoplasty in Subjects With Fuchs' Endothelial Corneal Dystrophy
Recently, published literature has reported that performing a descemetorhexis in combination with topical Rho kinase (ROCK) inhibitor therapy was successful in clearing edematous corneas in patients with Fuchs Endothelial Corneal Dystrophy.
Ripasudil hydrochloride hydrate( Glanatec ophthalmic solution 0.4%), a potent ROCK inhibitor, has been approved in Japan since 2014 for ocular use in the treatment of glaucoma. Ripasudil acts as an IOP-lowering drug by affecting aqueous outflow through the trabecular meshwork and Schlemm's canal.
The goal of this study is to test the potential benefits of Ripasudil therapy administered after Descemet Membrane Endothelial Keratoplasty (DMEK) surgery. We believe that performing a standard DMEK surgery in combination with Ripasudil treatment in patients with Fuchs Endothelial Corneal Dystrophy could accelerate endothelial cell healing and clear edematous corneas faster, with less post-operative complications.
- Conditions
- Fuchs Endothelial Dystrophy
- Being tested
- Glanatec, Optive, Ophthalmic Solution, Descemet Membrane Endothelial Keratoplasty
- 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.
GlanatecDrug
Also called Ripasudil
Rho kinase Inhibitor
Optive, Ophthalmic SolutionDrug
Also called Optive, artificial tears
artificial tears (placebo)
Descemet Membrane Endothelial KeratoplastyProcedure or surgery
Also called DMEK
Partial thickness corneal transplant that replaces only the diseased corneal endothelium and descemet membrane of the recipient.
| Study group | Role | What they receive |
|---|---|---|
| Glanatec | Experimental | Glanatec eye drops will be administered 6x per day for 2-4 weeks Receives: Drug: Glanatec; Procedure: Descemet Membrane Endothelial Keratoplasty |
| Placebo Control | Placebo comparator | Optive artificial tears will be administered 6x per day for 2-4 weeks Receives: Drug: Optive, Ophthalmic Solution; Procedure: Descemet Membrane Endothelial Keratoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to corneal clearance
Slit lamp examinations and corneal OCT measurements will be taken in a longitudinal fashion to compare corneal clearance and stabilization.
Measured: 6 months
Secondary outcomes (3)
Best corrected visual acuity
Longitudinal best corrected visual acuity tests will be performed to compare the time course of best vision attained and reported in Snellen units.
Measured: 6 months
Endothelial cell density
Specular imaging will be conducted at 3 and 6 month postoperative to compare endothelial cells loss.
Measured: 6 months
Post surgery complications
Number of graft detachments requiring a re-bubble procedure and number of graft failures will be recorded.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start25 Mar 2019
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2025 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michael D. Straiko, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Lions VisionGift Research, Eye Bank Association of America
- Responsible party
- Sponsor-investigator, Michael D. Straiko, MD, Legacy Health System
- Investigators
- Michael D Straiko, M.D., Principal investigator, Devers Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03813056
- Sponsor's protocol ID
- RDMEK-01
- Status last verified
- Mar 2024
- First submitted
- 19 Jan 2019
- Last updated
- 20 Mar 2024
- Results posted
- No
- 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 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Interventional, Double-blind, Single-center Study of the Effects of Ripasudil on Cornea Clearing After Descemet Membrane Endothelial Keratoplasty in Subjects With Fuchs' Endothelial Corneal Dystrophy
- ClinicalTrials.gov ID
- NCT03813056
- Acronym / sponsor ID
- RDMEK-01
- Conditions
- Fuchs Endothelial Dystrophy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Michael D. Straiko, MDUniversity, hospital or other
- Collaborators
- Lions VisionGift Research, Eye Bank Association of America
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 23 Jan 2019 (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.
Recently, published literature has reported that performing a descemetorhexis in combination with topical Rho kinase (ROCK) inhibitor therapy was successful in clearing edematous corneas in patients with Fuchs Endothelial Corneal Dystrophy.
Ripasudil hydrochloride hydrate( Glanatec ophthalmic solution 0.4%), a potent ROCK inhibitor, has been approved in Japan since 2014 for ocular use in the treatment of glaucoma. Ripasudil acts as an IOP-lowering drug by affecting aqueous outflow through the trabecular meshwork and Schlemm's canal.
The goal of this study is to test the potential benefits of Ripasudil therapy administered after Descemet Membrane Endothelial Keratoplasty (DMEK) surgery. We believe that performing a standard DMEK surgery in combination with Ripasudil treatment in patients with Fuchs Endothelial Corneal Dystrophy could accelerate endothelial cell healing and clear edematous corneas faster, with less post-operative complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glanatec | Experimental | Drug: Glanatec, Procedure: Descemet Membrane Endothelial KeratoplastyGlanatec eye drops will be administered 6x per day for 2-4 weeks |
| Placebo Control | Placebo comparator | Drug: Optive, Ophthalmic Solution, Procedure: Descemet Membrane Endothelial KeratoplastyOptive artificial tears will be administered 6x per day for 2-4 weeks |
Who may qualify
- Ages
- 30 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed clinically with Fuchs endothelial corneal dystrophy by the study investigator.
- Phakic or pseudophakic with posterior capsule supported, suture-fixated, or sulcus-supported posterior chamber intraocular lens.
- Fuchs dystrophy grades 2-5 on the Krachmer grading scale.
- Presence of central guttae and/or stromal edema being the primary cause of decreased vision.
- The peripheral cornea to the central 6mm is devoid of guttata changes.
Key exclusion criteria (8 listed)
- Uncontrolled glaucoma (IOP >25 mmHg).
- Presence of secondary corneal pathology such as infective or autoimmune keratitis.
- Advanced corneal stromal edema with bullae on slit-lamp biomicroscopy.
- History of herpes simplex virus or cytomegalovirus keratitis.
- Prior penetrating keratoplasty.
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 |
|---|---|---|
| GlanatecAlso: RipasudilRho kinase Inhibitor | Drug | Glanatec |
| Optive, Ophthalmic SolutionAlso: Optive, artificial tearsartificial tears (placebo) | Drug | Placebo Control |
| Descemet Membrane Endothelial KeratoplastyAlso: DMEKPartial thickness corneal transplant that replaces only the diseased corneal endothelium and descemet membrane of the recipient. | Procedure or surgery | Glanatec, Placebo Control |
Primary outcome
Time to corneal clearance
Time frame: 6 months
Slit lamp examinations and corneal OCT measurements will be taken in a longitudinal fashion to compare corneal clearance and stabilization.
3 secondary outcomes
Best corrected visual acuity
Time frame: 6 months
Endothelial cell density
Time frame: 6 months
Post surgery complications
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
- 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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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.
Michael D Straiko, M.D. principal investigator
Devers Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Glanatec, Optive, Ophthalmic Solution and Descemet Membrane Endothelial Keratoplasty in people with Fuchs Endothelial Dystrophy, run by Michael D. Straiko, 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 6 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: status not confirmed, as of the sponsor's last update on 20 Mar 2024. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alex J Bauer, B.S. (503-413-8377, alex@visiongift.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to corneal clearance (time frame: 6 months). 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 20 Mar 2024.