Glanatec(R) for Descemet Stripping in Fuch's Endothelial Dystrophy (NCT03249337) | Clinical Trial Compass
RecruitingPhase 4
Glanatec(R) for Descemet Stripping in Fuch's Endothelial Dystrophy
United States30 participantsStarted 2017-12-06
Plain-language summary
In brief, the objective of this study is to investigate whether the drug Glanatec ® which is approved in Japan for glaucoma and ocular hypertension, can be used in patients with Fuchs endothelial dystrophy who have had a descemet stripping procedure without endothelial keratoplasty. While some limited data exists as a proof of concept in in vitro or animal studies, and Glanatec® has been successfully used in a recently published case series for this indication, there is insufficient data to show that this drug can be effectively used for corneal cell clearing while maintaining patient safety.
The goal of the study is to provide sufficient proof of concept for the use of this drug in patients with FED whose only treatment alternative is to undergo corneal transplant.
Who can participate
Age range
18 Years – 91 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 seco…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.