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NCT03813056 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Fuchs Endothelial Dystrophy, sponsored by Michael D. Straiko, MD.

Recruiting
Registry status
Phase 2
Development phase
72
Enrollment target
1
Study location

NCT03813056: Recruiting Phase 2 study of Fuchs Endothelial Dystrophy, sponsored by Michael D. Straiko, MD.

NCT03813056 is a Phase 2 study of Fuchs Endothelial Dystrophy that is actively recruiting participants, run by Michael D. Straiko, MD. The registered enrollment target is 72 participants, below the 487-participant average among 7 other Fuchs Endothelial Dystrophy trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03813056, a Phase 2 study of Fuchs Endothelial Dystrophy, is actively recruiting participants, sponsored by Michael D. Straiko, MD.

RECRUITING
Registry status
Phase 2
Development phase
72 participants
Enrollment target
1
Study location

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 Studied

Fuchs Endothelial Dystrophy

Interventions

  • DRUG Glanatec
  • DRUG Optive, Ophthalmic Solution
  • PROCEDURE Descemet Membrane Endothelial Keratoplasty

Study Locations (1)

Oregon

  • Devers Eye Institute - Portland

Trial Details

FieldValue
Enrollment Target 72 participants
Start Date 2019-03-25
Est. Completion 2025-02-01
Phase Phase 2
Michael D. Straiko, MD

1 total trials

What NCT03813056 shows while recruiting

NCT03813056 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 487-participant average among 7 other Fuchs Endothelial Dystrophy trials with a reported enrollment target (85% lower).

The record links to 1 condition, with Fuchs Endothelial Dystrophy appearing as the primary indexed condition, and to 3 interventions - of which Glanatec is the first listed.

NCT03813056 reports a single indexed study location in Oregon.

Frequently Asked Questions

What is clinical trial NCT03813056 about?

NCT03813056 is a clinical study titled "Ripasudil for Enhanced Corneal Clearing Following Descemet Membrane Endothelial Keratoplasty in Fuchs' Dystrophy". 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 solut...

What is the current status of trial NCT03813056?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2019-03-25. Estimated completion is 2025-02-01.

What conditions does trial NCT03813056 study?

This clinical trial studies the following conditions: Fuchs Endothelial Dystrophy.

What interventions are being tested in trial NCT03813056?

The interventions under investigation include: Glanatec (DRUG), Optive, Ophthalmic Solution (DRUG), Descemet Membrane Endothelial Keratoplasty (PROCEDURE).

Who is sponsoring clinical trial NCT03813056?

This trial is sponsored by Michael D. Straiko, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03813056 being conducted?

This trial has 1 study location across Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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More recruiting context for NCT03813056

Source: ClinicalTrials.gov NCT03813056, the US trial registry maintained by the National Library of Medicine. NCT03813056 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.