Health TrialsbyHealthPanel

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

ConditionFuchs' 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Ripasudil hydrochloride hydrate 0.4% ophthalmic solution

    Drug

    the ophthalmic solution will be administered three or six per times per day in the eye designated as the "Study Eye" upon study enrollment

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Glanatec(R) 3 times a dayActive comparator 1 intervention
Group B: Glanatec (R) 6 times a dayActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Marian Macsai, MD

Lead sponsor

Endeavor Health

Sponsor institution

Source ClinicalTrials.gov
Apply now