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Ripasudil 0.4% Eye Drops in Fuchs Endothelial Corneal Dystrophy

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ClinicalTrials.gov Identifier: NCT03575130
Recruitment Status : Recruiting
First Posted : July 2, 2018
Last Update Posted : July 12, 2018
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

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.


Condition or disease Intervention/treatment Phase
Fuchs' Endothelial Dystrophy Fuchs Dystrophy Corneal Endothelial Dystrophy Corneal Endothelial Cell Loss Cornea Guttata Drug: Ripasudil eye drops Drug: Optive eye drops Procedure: Descemetorhexis Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : June 5, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018


Arm Intervention/treatment
Experimental: Glanatec Drug: Ripasudil eye drops
Rho-kinase-Inhibitor (IMP)

Procedure: Descemetorhexis
Corneal endothelial cells are removed prior to IMP administration by Descemetorhexis.

Placebo Comparator: Placebo Drug: Optive eye drops
Artificial tears (placebo)

Procedure: Descemetorhexis
Corneal endothelial cells are removed prior to IMP administration by Descemetorhexis.




Primary Outcome Measures :
  1. The occurrence of serious adverse reaction within the observation period of 3 months after descemetorhexis. [ Time Frame: 3 Months ]

Secondary Outcome Measures :
  1. 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 ]
  2. effect of ripasudil on corneal endothelial cell density (ECD) [ Time Frame: within the observation period of 6 months ]
  3. effect of ripasudil on corneal thickness [ Time Frame: within the observation period of 6 months ]
  4. effect of on visual acuity (BCVA) [ Time Frame: within the observation period of 6 months ]
  5. effect of ripasudil on contrast sensitivity [ Time Frame: within the observation period of 6 months ]
  6. assess the need of rescue therapy (DMEK) [ Time Frame: within the observation period of 6 months ]


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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written informed consent obtained from the subject
  2. Understanding of study procedures and willingness to abide by all procedures during the course of the study.
  3. Age range: 18-70 years
  4. 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
  5. Reduced visual acuity, defined as BCVA <20/30
  6. Woman of childbearing potential must be using a highly effective method of birth control.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03575130


Locations
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Germany
Department of Ophthalmology, University of Erlangen-Nürnberg Recruiting
Erlangen, Germany, 91054
Contact: Friedrich E Kruse, Prof.    +49913185 ext 34477    friedrich.kruse@uk-erlangen.de   
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School

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Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT03575130     History of Changes
Other Study ID Numbers: 2017-002490-19
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: July 12, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Eye Diseases
Eye Diseases, Hereditary
Ophthalmic Solutions
Fuchs' Endothelial Dystrophy
Corneal Endothelial Cell Loss
Iridocorneal Endothelial Syndrome
Corneal Dystrophies, Hereditary
Corneal Diseases
Genetic Diseases, Inborn
Postoperative Complications
Pathologic Processes
Iris Diseases
Uveal Diseases
Pharmaceutical Solutions