Using Glanatec® to treat Fuchs' Endothelial Dystrophy
A Pilot Study For Efficacy And Safety Of Glanatec® Opthalmic Solution 0.4% On Corneal Edema And Endothelial Cell Counts In Subjects With Fuchs Endothelial Dystrophy Undergoing Descemet Stripping Without Endothelial Keratoplasty
PHASE4 · Endeavor Health · NCT03249337
This study is testing if Glanatec®, a glaucoma medication, can help clear corneal cells in people with Fuchs' Endothelial Dystrophy who have had a specific eye surgery.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 91 Years |
| Sex | All |
| Sponsor | Endeavor Health (other) |
| Locations | 1 site (Glenview, Illinois) |
| Trial ID | NCT03249337 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 30 to 90 diagnosed with Fuchs' dystrophy and experiencing visual symptoms due to central guttae.
Not a fit: Patients with conditions other than Fuchs' dystrophy or those who do not meet the specific eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide an alternative to corneal transplant for patients with Fuchs' Endothelial Dystrophy.
How similar studies have performed: While limited data exists from previous case series, this approach is still considered novel and requires further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Glenview, Illinois
- NorthShore University HealthSystem — Glenview, Illinois, United States (RECRUITING)
Study contacts
- Study coordinator: Duanny Alva, MPH
- Email: dalva@northshore.org
- Phone: 847-570-1783
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Fuchs' Endothelial Dystrophy