Glanatec(R) for Descemet Stripping in Fuch's Endothelial Dystrophy

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-91
SponsorMarian Macsai, MD

About this trial

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

Qualifiers

• 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

Disqualifiers

• 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

Trial design

Treatments tested in this trial

  • Ripasudil hydrochloride hydrate 0.4% ophthalmic solution

Treatment groups

30 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Marian Macsai, MD

Lead sponsor

Endeavor Health

Sponsor institution