A Phase 2 interventional study of Ripasudil eye drops and Optive eye drops in Fuchs' Endothelial Dystrophy, Fuchs Dystrophy and Corneal Endothelial Dystrophy, sponsored by University of Erlangen-Nürnberg Medical School. Status unknown at 1 site in Germany. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2018-07-12.
Sponsored by University of Erlangen-Nürnberg Medical School · Phase 2, Interventional, and Treatment
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.
58 studies on the registry are indexed under Corneal Dystrophies, Hereditary; 11 are open to participants now.
This study's planned enrollment of 21 is below the median of 24 across 38 interventional studies indexed under Corneal Dystrophies, Hereditary.
Browse Corneal Dystrophies, Hereditary studies →University of Erlangen-Nürnberg Medical School is the lead sponsor of 267 studies on the registry; 51 are open to participants now.
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Inclusion Criteria:
Drug: Ripasudil eye drops · Procedure: Descemetorhexis
Drug: Optive eye drops · Procedure: Descemetorhexis
Rho-kinase-Inhibitor (IMP)
Artificial tears (placebo)
Corneal endothelial cells are removed prior to IMP administration by Descemetorhexis.
The occurrence of serious adverse reaction within the observation period of 3 months after descemetorhexis.
Time frame: 3 Months
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
Plan to share: No
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This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Corneal Dystrophies, Hereditary→
University of Erlangen-Nürnberg Medical School