A Phase 4 interventional study of Ripasudil hydrochloride hydrate 0.4% ophthalmic solution in Fuchs' Endothelial Dystrophy, sponsored by Marian Macsai, MD. Recruiting at 1 site in United States. Open to participants aged 18 Years to 91 Years. Per ClinicalTrials.gov, last updated 2021-08-11.
Sponsored by Marian Macsai, MD · Phase 4, Interventional, and Treatment
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.
Ability to understand read and sign the informed consent form.
Exclusion Criteria:
Uncontrolled glaucoma (IOP >25 mmHg)
Drug: Ripasudil hydrochloride hydrate 0.4% ophthalmic solution
Drug: Ripasudil hydrochloride hydrate 0.4% ophthalmic solution
the ophthalmic solution will be administered three or six per times per day in the eye designated as the "Study Eye" upon study enrollment
Also known as: Glanatec
Corneal Clearing
The first primary aim of this study is to examine whether Glanatec® administered three or six times daily significantly increases corneal clearing at 12 months versus baseline in patients with Fuchs endothelial dystrophy (FED) undergoing Descemet stripping
Time frame: 12 months
pachymetry measurement
The second primary aim of this study is to examine whether Glanatec® administered three or six times daily significantly reduces the pachymetry measurement at 12 months versus baseline in patients with Fuchs endothelial dystrophy (FED) undergoing Descemet stripping.
Time frame: 12 months
Visual Acuity
The secondary aim of this study is to examine whether Glanatec® administered three or six times daily affects best corrected visual acuity at 12 months (measured by Snellen lines) as compared to baseline, patients with Fuchs endothelial dystrophy (FED) undergoing Descemet stripping.
Time frame: 12 months
Plan to share: No
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