Ripasudil 0.4% Eye Drops in Fuchs Endothelial Corneal Dystrophy
Primary Purpose
Fuchs' Endothelial Dystrophy, Fuchs Dystrophy, Corneal Endothelial Dystrophy
Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Ripasudil eye drops
Optive eye drops
Descemetorhexis
Sponsored by
About this trial
This is an interventional treatment trial for Fuchs' Endothelial Dystrophy
Eligibility Criteria
Inclusion Criteria:
- 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.
Sites / Locations
- Department of Ophthalmology, University of Erlangen-NürnbergRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Glanatec
Placebo
Arm Description
Outcomes
Primary Outcome Measures
The occurrence of serious adverse reaction within the observation period of 3 months after descemetorhexis.
Secondary Outcome Measures
rate of adverse event, adverse reaction, serious adverse event, serious adverse reaction and suspected unexpected serious adverse reaction
effect of ripasudil on corneal endothelial cell density (ECD)
effect of ripasudil on corneal thickness
effect of on visual acuity (BCVA)
effect of ripasudil on contrast sensitivity
assess the need of rescue therapy (DMEK)
Full Information
NCT ID
NCT03575130
First Posted
June 8, 2018
Last Updated
July 10, 2018
Sponsor
University of Erlangen-Nürnberg Medical School
1. Study Identification
Unique Protocol Identification Number
NCT03575130
Brief Title
Ripasudil 0.4% Eye Drops in Fuchs Endothelial Corneal Dystrophy
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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 5, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fuchs' Endothelial Dystrophy, Fuchs Dystrophy, Corneal Endothelial Dystrophy, Corneal Endothelial Cell Loss, Cornea Guttata
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
21 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Glanatec
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ripasudil eye drops
Intervention Description
Rho-kinase-Inhibitor (IMP)
Intervention Type
Drug
Intervention Name(s)
Optive eye drops
Intervention Description
Artificial tears (placebo)
Intervention Type
Procedure
Intervention Name(s)
Descemetorhexis
Intervention Description
Corneal endothelial cells are removed prior to IMP administration by Descemetorhexis.
Primary Outcome Measure Information:
Title
The occurrence of serious adverse reaction within the observation period of 3 months after descemetorhexis.
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
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
Title
effect of ripasudil on corneal endothelial cell density (ECD)
Time Frame
within the observation period of 6 months
Title
effect of ripasudil on corneal thickness
Time Frame
within the observation period of 6 months
Title
effect of on visual acuity (BCVA)
Time Frame
within the observation period of 6 months
Title
effect of ripasudil on contrast sensitivity
Time Frame
within the observation period of 6 months
Title
assess the need of rescue therapy (DMEK)
Time Frame
within the observation period of 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Facility Information:
Facility Name
Department of Ophthalmology, University of Erlangen-Nürnberg
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Friedrich E Kruse, Prof.
Phone
+49913185
Ext
34477
Email
friedrich.kruse@uk-erlangen.de
12. IPD Sharing Statement
Plan to Share IPD
No
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Ripasudil 0.4% Eye Drops in Fuchs Endothelial Corneal Dystrophy
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