CClinicalTrials.gg
Status unknownNCT03575130Updated Jul 12, 2018

Ripasudil 0.4% Eye Drops in Fuchs Endothelial Corneal Dystrophy

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 sponsor has not verified this record recently (last verified Jul 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
18 Years to 95 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Fuchs' Endothelial Dystrophy
  • Fuchs Dystrophy
  • Corneal Endothelial Dystrophy
  • Corneal Endothelial Cell Loss
  • Cornea Guttata
03

In context

Corneal Dystrophies, Hereditary

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 →

Lead sponsor

University of Erlangen-Nürnberg Medical School is the lead sponsor of 267 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
21 participants (estimated)

Study arms

  • Experimental
    Glanatec

    Drug: Ripasudil eye drops · Procedure: Descemetorhexis

  • Placebo comparator
    Placebo

    Drug: Optive eye drops · Procedure: Descemetorhexis

Interventions

  • DrugRipasudil eye drops

    Rho-kinase-Inhibitor (IMP)

  • DrugOptive eye drops

    Artificial tears (placebo)

  • ProcedureDescemetorhexis

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

06

What researchers measure

Primary outcomes

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

    Time frame: 3 Months

Secondary outcomes

  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

07

Study locations

1 of 1 sites recruiting
  • Department of Ophthalmology, University of Erlangen-Nürnberg
    Erlangen, 91054, Germany
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03575130
Lead sponsor
University of Erlangen-Nürnberg Medical School
Responsible party
Sponsor
First posted
Jul 2, 2018
Start date
Jun 5, 2018
Primary completion
Dec 31, 2018 (estimated)
Completion
Dec 31, 2018 (estimated)
Last update
Jul 12, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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