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Ripasudil for Enhanced Corneal Clearing Following Descemet Membrane Endothelial Keratoplasty in Fuchs' Dystrophy

NCT03813056 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2024-03-20

No results posted yet for this study

Summary

Recently, published literature has reported that performing a descemetorhexis in combination with topical Rho kinase (ROCK) inhibitor therapy was successful in clearing edematous corneas in patients with Fuchs Endothelial Corneal Dystrophy.

Ripasudil hydrochloride hydrate( Glanatec ophthalmic solution 0.4%), a potent ROCK inhibitor, has been approved in Japan since 2014 for ocular use in the treatment of glaucoma. Ripasudil acts as an IOP-lowering drug by affecting aqueous outflow through the trabecular meshwork and Schlemm's canal.

The goal of this study is to test the potential benefits of Ripasudil therapy administered after Descemet Membrane Endothelial Keratoplasty (DMEK) surgery. We believe that performing a standard DMEK surgery in combination with Ripasudil treatment in patients with Fuchs Endothelial Corneal Dystrophy could accelerate endothelial cell healing and clear edematous corneas faster, with less post-operative complications.

Conditions

  • Fuchs Endothelial Dystrophy

Interventions

DRUG

Glanatec

Rho kinase Inhibitor

DRUG

Optive, Ophthalmic Solution

artificial tears (placebo)

PROCEDURE

Descemet Membrane Endothelial Keratoplasty

Partial thickness corneal transplant that replaces only the diseased corneal endothelium and descemet membrane of the recipient.

Sponsors & Collaborators

  • Lions VisionGift Research

    collaborator OTHER

  • Eye Bank Association of America

    collaborator OTHER

  • Michael D. Straiko, MD

    lead OTHER

Principal Investigators

  • Michael D Straiko, M.D. · Devers Eye Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-25
Primary Completion
2025-02-01
Completion
2025-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03813056 on ClinicalTrials.gov