NCT03249337 Glanatec(R) for Descemet Stripping in Fuch's Endothelial Dystrophy
| NCT ID | NCT03249337 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Marian Macsai, MD |
| Condition | Fuchs' Endothelial Dystrophy |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2017-12-06 |
| Primary Completion | 2021-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 30 participants in total. It began in 2017-12-06 with a primary completion date of 2021-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03249337 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 91 Years, studying Fuchs' Endothelial Dystrophy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03249337 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT03249337 currently recruiting?
Yes, NCT03249337 is actively recruiting participants. Contact the research team at dalva@northshore.org for enrollment information.
Where is the NCT03249337 trial being conducted?
This trial is being conducted at Glenview, United States.
Who is sponsoring the NCT03249337 clinical trial?
NCT03249337 is sponsored by Marian Macsai, MD. The trial plans to enroll 30 participants.