Fuchs' Endothelial DystrophyPhase 2NCT03575130
Ripasudil 0.4% Eye Drops in Fuchs Endothelial Corneal Dystrophy
A Phase 2 study testing Ripasudil eye drops, Optive eye drops and Descemetorhexis in people with Fuchs' Endothelial Dystrophy and Fuchs Dystrophy, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
The cornea forms our "window to the world". Hence, its transparency is of utmost importance for vision. Corneal endothelium plays a central role in the maintenance of a transparent corneal stroma. It limits stromal fluid uptake from the anterior chamber of the eye through the formation of tight junctions. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Fuchs' Endothelial Dystrophy, Fuchs Dystrophy, Corneal Endothelial Dystrophy
- What is being tested?
- Ripasudil eye drops, Optive eye drops and Descemetorhexis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteGermany
- Study dates
- 5 Jun 2018to 31 Dec 2018
- 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 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent obtained from the subject
- Understanding of study procedures and willingness to abide by all procedures during the course of the study.
- Age range: 18-70 years
- Diagnosis of moderate to advanced FECD with central guttae and clinical relevant corneal endothelial cell loss of <1,000 cells/mm2 and clinical indication of surgical intervention (descemetorhexis) with or without accompanying cataract operation
- Reduced visual acuity, defined as BCVA <20/30
- Woman of childbearing potential must be using a highly effective method of birth control.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Ophthalmology, University of Erlangen-Nürnberg
Erlangen, 91054
Friedrich E Kruse, Prof., +49913185 ext. 34477, friedrich.kruse@uk-erlangen.de
About this study
Official title: Prospective Single-centre Randomized Observer-blind Placebo-controlled Parallel-group Phase IIa Clinical Trial to Investigate the Safety and Efficacy of Ripasudil 0.4% Eye Drops After Descemetorhexis in Patients With Moderate to Advanced Fuchs Endothelial Corneal Dystrophy (FECD)
The cornea forms our "window to the world". Hence, its transparency is of utmost importance for vision. Corneal endothelium plays a central role in the maintenance of a transparent corneal stroma. It limits stromal fluid uptake from the anterior chamber of the eye through the formation of tight junctions. Simultaneously, fluid is actively transported from corneal stroma into the anterior chamber. This maintains the corneal stroma in a state of relative dehydration, thereby ensuring a constant distance of stromal collagen lamellae to each other, which in turn forms the basis for transparency of this tissue. If however corneal endothelial function is impaired, stromal swelling leads to corneal clouding and loss of vision.
Fuchs endothelial corneal dystrophy represents the most common form of corneal dystrophy. It occurs sporadically, however in some cases autosomal dominant inheritance has been described. This condition leads to progressive loss of corneal endothelium (typically around the age of 50-60 years), causing visual impairment due to swelling and opacification of corneal stroma.
Read more
Cell culture experiments have been able to show that chemical inhibitors of Rho-Kinase promote corneal endothelial cell proliferation and reduce apoptosis, while topical application in an animal model promoted corneal endothelial wound healing. This has prompted the notion of using topical Rho-kinase-inhibitor treatment to support endothelial cell regeneration in Fuchs endothelial corneal dystrophy.
Since September 2014, Rho-kinase-inhibitor eye drops (ripasudil) are clinically available in Japan for reduction of intraocular pressure in Glaucoma patients. Ripasudil eye drops therefore represent a strong candidate for safe and effective adjunctive treatment in patients with Fuchs corneal endothelial cell dystrophy.
- Conditions
- Fuchs' Endothelial Dystrophy, Fuchs Dystrophy, Corneal Endothelial Dystrophy, Corneal Endothelial Cell Loss, Cornea Guttata
- Being tested
- Ripasudil eye drops, Optive eye drops, Descemetorhexis
- Medical subject headings
- Fuchs' Endothelial Dystrophy, Corneal Dystrophy, Posterior Polymorphous, 1, Corneal Endothelial Cell Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ripasudil eye dropsDrug
Rho-kinase-Inhibitor (IMP)
Optive eye dropsDrug
Artificial tears (placebo)
DescemetorhexisProcedure or surgery
Corneal endothelial cells are removed prior to IMP administration by Descemetorhexis.
| Study group | Role | What they receive |
|---|---|---|
| Glanatec | Experimental | Not described Receives: Drug: Ripasudil eye drops; Procedure: Descemetorhexis |
| Placebo | Placebo comparator | Not described Receives: Drug: Optive eye drops; Procedure: Descemetorhexis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The occurrence of serious adverse reaction within the observation period of 3 months after descemetorhexis.
Measured: 3 Months
Secondary outcomes (6)
rate of adverse event, adverse reaction, serious adverse event, serious adverse reaction and suspected unexpected serious adverse reaction
Measured: within the observation period of 6 months
effect of ripasudil on corneal endothelial cell density (ECD)
Measured: within the observation period of 6 months
effect of ripasudil on corneal thickness
Measured: within the observation period of 6 months
effect of on visual acuity (BCVA)
Measured: within the observation period of 6 months
effect of ripasudil on contrast sensitivity
Measured: within the observation period of 6 months
assess the need of rescue therapy (DMEK)
Measured: within the observation period of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start5 Jun 2018
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (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.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03575130
- Sponsor's protocol ID
- 2017-002490-19
- Other IDs
- 2017
- Status last verified
- Jul 2018
- First submitted
- 8 Jun 2018
- Last updated
- 12 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Single-centre Randomized Observer-blind Placebo-controlled Parallel-group Phase IIa Clinical Trial to Investigate the Safety and Efficacy of Ripasudil 0.4% Eye Drops After Descemetorhexis in Patients With Moderate to Advanced Fuchs Endothelial Corneal Dystrophy (FECD)
- ClinicalTrials.gov ID
- NCT03575130
- Acronym / sponsor ID
- 2017-002490-19
- Conditions
- Fuchs' Endothelial Dystrophy, Fuchs Dystrophy, Corneal Endothelial Dystrophy, Corneal Endothelial Cell Loss, Cornea Guttata
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 2 Jul 2018 (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.
The cornea forms our "window to the world". Hence, its transparency is of utmost importance for vision. Corneal endothelium plays a central role in the maintenance of a transparent corneal stroma. It limits stromal fluid uptake from the anterior chamber of the eye through the formation of tight junctions. Simultaneously, fluid is actively transported from corneal stroma into the anterior chamber. This maintains the corneal stroma in a state of relative dehydration, thereby ensuring a constant distance of stromal collagen lamellae to each other, which in turn forms the basis for transparency of this tissue. If however corneal endothelial function is impaired, stromal swelling leads to corneal clouding and loss of vision.
Fuchs endothelial corneal dystrophy represents the most common form of corneal dystrophy. It occurs sporadically, however in some cases autosomal dominant inheritance has been described. This condition leads to progressive loss of corneal endothelium (typically around the age of 50-60 years), causing visual impairment due to swelling and opacification of corneal stroma.
Cell culture experiments have been able to show that chemical inhibitors of Rho-Kinase promote corneal endothelial cell proliferation and reduce apoptosis, while topical application in an animal model promoted corneal endothelial wound healing. This has prompted the notion of using topical Rho-kinase-inhibitor treatment to support endothelial cell regeneration in Fuchs endothelial corneal dystrophy.
Since September 2014, Rho-kinase-inhibitor eye drops (ripasudil) are clinically available in Japan for reduction of intraocular pressure in Glaucoma patients. Ripasudil eye drops therefore represent a strong candidate for safe and effective adjunctive treatment in patients with Fuchs corneal endothelial cell dystrophy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glanatec | Experimental | Drug: Ripasudil eye drops, Procedure: Descemetorhexis |
| Placebo | Placebo comparator | Drug: Optive eye drops, Procedure: Descemetorhexis |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent obtained from the subject
- Understanding of study procedures and willingness to abide by all procedures during the course of the study.
- Age range: 18-70 years
- Diagnosis of moderate to advanced FECD with central guttae and clinical relevant corneal endothelial cell loss of <1,000 cells/mm2 and clinical indication of surgical intervention (descemetorhexis) with or without accompanying cataract operation
- Reduced visual acuity, defined as BCVA <20/30
Key exclusion criteria (0 listed)
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 eye dropsRho-kinase-Inhibitor (IMP) | Drug | Glanatec |
| Optive eye dropsArtificial tears (placebo) | Drug | Placebo |
| DescemetorhexisCorneal endothelial cells are removed prior to IMP administration by Descemetorhexis. | Procedure or surgery | Glanatec, Placebo |
Primary outcome
The occurrence of serious adverse reaction within the observation period of 3 months after descemetorhexis.
Time frame: 3 Months
6 secondary outcomes
rate of adverse event, adverse reaction, serious adverse event, serious adverse reaction and suspected unexpected serious adverse reaction
Time frame: within the observation period of 6 months
effect of ripasudil on corneal endothelial cell density (ECD)
Time frame: within the observation period of 6 months
effect of ripasudil on corneal thickness
Time frame: within the observation period of 6 months
effect of on visual acuity (BCVA)
Time frame: within the observation period of 6 months
effect of ripasudil on contrast sensitivity
Time frame: within the observation period of 6 months
assess the need of rescue therapy (DMEK)
Time frame: within the observation period of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2018.
- 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. This study is not recruiting at the moment.
Department of Ophthalmology, University of Erlangen-Nürnberg
Erlangen, Germany
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 Ripasudil eye drops, Optive eye drops and Descemetorhexis in people with Fuchs' Endothelial Dystrophy and Fuchs Dystrophy, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
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 0 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 12 Jul 2018. 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 Germany. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The occurrence of serious adverse reaction within the observation period of 3 months after descemetorhexis. (time frame: 3 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 12 Jul 2018.