Glanatec(R) for Descemet Stripping in Fuch's Endothelial Dystrophy
| Status: | Recruiting |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - 91 |
| Updated: | 3/1/2019 |
| Start Date: | December 6, 2017 |
| End Date: | July 2020 |
| Contact: | Mira Shiloach, M.S |
| Email: | mshiloach@northshore.org |
| Phone: | 847-657-1750 |
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
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.
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.
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.
- Psuedophakic 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.
We found this trial at
1
site
Glenview, Illinois 60026
Principal Investigator: Marian Macsai, MD
Phone: 847-657-1750
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