Ripasudil 0.4% Eye Drops in Fuchs Endothelial Corneal Dystrophy

NCT03575130 | Unknown Phase 2

• 1 other identifier: 2017-002490-19
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The occurrence of serious adverse reaction within the observation period of 3 months after descemetorhexis.

  3 Months

Secondary Outcomes (6)

• rate of adverse event, adverse reaction, serious adverse event, serious adverse reaction and suspected unexpected serious adverse reaction

  within the observation period of 6 months

• effect of ripasudil on corneal endothelial cell density (ECD)

  within the observation period of 6 months

• effect of ripasudil on corneal thickness

  within the observation period of 6 months

• effect of on visual acuity (BCVA)

  within the observation period of 6 months

• effect of ripasudil on contrast sensitivity

  within the observation period of 6 months

Study Arms (2)

Glanatec

EXPERIMENTAL

Drug: Ripasudil eye drops; Procedure: Descemetorhexis

Placebo

PLACEBO COMPARATOR

Drug: Optive eye drops; Procedure: Descemetorhexis

Interventions

Ripasudil eye drops DRUG

Rho-kinase-Inhibitor (IMP)

Glanatec

Optive eye drops DRUG

Artificial tears (placebo)

Placebo

Descemetorhexis PROCEDURE

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

Glanatec; Placebo

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

Department of Ophthalmology, University of Erlangen-Nürnberg

Erlangen, 91054, Germany

RECRUITING

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy; Corneal Dystrophy, Posterior Polymorphous, 1; Corneal Endothelial Cell Loss

Condition Hierarchy (Ancestors)

Corneal Dystrophies, Hereditary; Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Eye Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2018
• First Posted: July 2, 2018
• Study Start: June 5, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: July 12, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)