Using Glanatec® to treat Fuchs' Endothelial Dystrophy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the use of Glanatec®, a drug approved in Japan for glaucoma, in patients with Fuchs' Endothelial Dystrophy who have undergone a descemet stripping procedure without endothelial keratoplasty. The aim is to determine if Glanatec® can effectively clear corneal cells while ensuring patient safety. The study will provide proof of concept based on previous limited data and case series that suggest potential benefits of this treatment. Participants will be monitored for their response to the medication and adherence to the treatment regimen.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* • 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 Criteria:

* • 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.

Where it's running

• NorthShore University HealthSystem
  Glenview, Illinois, United States Recruiting

Study contacts

• Study coordinator: Duanny Alva, MPH
• Email: dalva@northshore.org
• Phone: 847-570-1783

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Effects of Ripasudil on Patients with Fuchs' Endothelial Dystrophy Undergoing Cataract Surgery

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• OPTIMISE — safer steroid plans after DMEK cornea transplant

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.