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

Part of paid clinical trials in Glenview, Illinois.

Sponsor
Marian Macsai, MD
Study ID
NCT03249337
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Fuchs' Endothelial Dystrophy

Eligibility Criteria

Sex
ALL
Age
18 Years - 91 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Dec 6, 2017
Status verified
Aug 2021
Primary completion
Dec 31, 2021
Completion
Dec 31, 2021

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Glanatec(R) 3 times a day
  • Active Comparator: Glanatec (R) 6 times a day

Primary Outcome Measure

Corneal Clearing [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NorthShore University HealthSystemGlenviewIllinois60026
Duanny Alva, MPH
[email protected]
847-570-1783
Marian Macsai, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Glenview, IL

By research site
NorthShore University HealthSystem· Glenview, IL

Related Studies