Ripasudil 0.4% Eye Drops in Fuchs Endothelial Corneal Dystrophy

NCT ID: NCT03575130

Last Updated: 2018-07-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-05
• Study Completion Date: 2018-12-31

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.

Conditions

Fuchs' Endothelial Dystrophy; Fuchs Dystrophy; Corneal Endothelial Dystrophy; Corneal Endothelial Cell Loss; Cornea Guttata

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Glanatec

Group Type: EXPERIMENTAL

Ripasudil eye drops

Intervention Type: DRUG

Rho-kinase-Inhibitor (IMP)

Descemetorhexis

Intervention Type: PROCEDURE

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

Placebo

Group Type: PLACEBO_COMPARATOR

Optive eye drops

Intervention Type: DRUG

Artificial tears (placebo)

Descemetorhexis

Intervention Type: PROCEDURE

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

Interventions

Ripasudil eye drops

Rho-kinase-Inhibitor (IMP)

Intervention Type: DRUG

Optive eye drops

Artificial tears (placebo)

Intervention Type: DRUG

Descemetorhexis

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

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Ophthalmology, University of Erlangen-Nürnberg

Erlangen, , Germany

Site Status: RECRUITING

Countries

Germany

Facility Contacts

Friedrich E Kruse, Prof.

Role: primary

friedrich.kruse@uk-erlangen.de

+49913185 ext. 34477

Other Identifiers

2017-002490-19

Identifier Type: -

Identifier Source: org_study_id