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Glanatec® for Fuchs' Endothelial Dystrophy after Descemet Stripping

This study is looking into whether Glanatec® (ripasudil hydrochloride hydrate 0.4% ophthalmic solution), an eye drop approved in Japan for glaucoma, can help people with Fuchs' Endothelial Dystrophy (a condition where cells on the inside of the cornea die off) after they've had a Descemet stripping procedure (a surgery to remove damaged cells). Currently, the only other option for these patients is a corneal transplant. Researchers want to see if Glanatec® can help clear the cornea and is safe to use. You might be able to join if you are between 30 and 90 years old, can understand and follow instructions, and are willing to use the eye drops as directed. The study will measure how well your cornea clears and its thickness after 12 months. The current status of this study is unclear, and it plans to enroll 30 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 30 participants.
What's involved
You would need to apply Glanatec® eye drops three or six times a day to your designated 'Study Eye'.
Compensation
Not stated in the trial record.
Follow-up
Your corneal clearing and thickness will be measured at 12 months after starting the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03249337

Glanatec(R) for Descemet Stripping in Fuch's Endothelial Dystrophy

Recruiting
PHASE4Ages 18–91InterventionalTreatment
Marian Macsai, MD
~30 participants
Updated 2021-08-11 on ClinicalTrials.gov
What's tested:Ripasudil hydrochloride hydrate 0.4% ophthalmic solution

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Corneal Clearing
Measured over 12 months
+1 more outcome measured

Conditions

Fuchs' Endothelial Dystrophy

Explore related trials

Fuchs Endothelial Dystrophy

Where it's being run

1 sites across 1 states
Illinois1

Who to contact

Duanny Alva, MPH
[email protected]
847-570-1783
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

• Ability to understand read and sign the informed consent form.
Age between 30 and \<91 years
Ability to understand and follow instructions and study procedures
Willingness to comply with all study procedures and be available for the duration of the study
Ability to apply eye drop medication and willing to adhere to study medication regimen
Diagnosed with Fuchs dystrophy (clinically and on confocal microscopy) by the study investigator.
Pseudophakic FED with posterior capsule supported, suture-fixated, or sulcus-supported posterior chamber intraocular lens.
Fuchs dystrophy grades 2-4 on the Krachmer grading scale
Presence of central guttae deemed by the investigator to be the chief cause of visual symptoms, rather than cataract or corneal stromal edema
Clear peripheral cornea with an endothelial cell count \>1000 cells/mm2 on specular microscopy
Best corrected visual acuity in the study eye is 20/40 or worse at study enrollment
The patient is dissatisfied with current vision
The patient is otherwise to be offered a corneal graft
For females with reproductive potential, willingness to use highly effective contraception (e.g., hormonal contraception, barrier contraception, intrauterine device, or abstinence).
Indication for surgery may include cataract extraction and posterior chamber intraocular lens implantation

Exclusion

• Uncontrolled glaucoma (IOP \>25 mmHg)
Presence of secondary corneal pathology such as infective or autoimmune keratitis
Advanced corneal stromal edema defined as the presence of haze, bullae, or DM folds on slit-lamp biomicroscopy
History of herpes simplex virus or cytomegalovirus keratitis
Prior endothelial keratoplasty
Aphakic in study eye.
Allergy to any component of the Ripasudil hydrochloride hydrate 0.4% that will be used in the course of the study
For women of child-bearing potential: Pregnant or lactating, or planning to become pregnant within the next 6 months.
Any other ocular condition that, in the opinion of the investigator, may preclude the subject from study participation.

What this trial measures

  • Corneal Clearing12 months

    The first primary aim of this study is to examine whether Glanatec® administered three or six times daily significantly increases corneal clearing at 12 months versus baseline in patients with Fuchs endothelial dystrophy (FED) undergoing Descemet stripping

  • pachymetry measurement12 months

    The second primary aim of this study is to examine whether Glanatec® administered three or six times daily significantly reduces the pachymetry measurement at 12 months versus baseline in patients with Fuchs endothelial dystrophy (FED) undergoing Descemet stripping.