Actively Recruiting
Glanatec(R) for Descemet Stripping in Fuch's Endothelial Dystrophy
Led by Marian Macsai, MD · Updated on 2021-08-11
30
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Glanatec(R) for Descemet Stripping in Fuch's Endothelial Dystrophy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand, read, and sign the informed consent form
- Age between 30 and less than 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 follow the study medication regimen
- Diagnosed with Fuchs dystrophy clinically and on confocal microscopy by the study investigator
- Pseudophakic FED with posterior capsule supported, suture-fixated, or sulcus-supported posterior chamber intraocular lens
- Fuchs dystrophy grades 2 to 4 on the Krachmer grading scale
- Presence of central guttae causing visual symptoms rather than cataract or corneal stromal edema
- Clear peripheral cornea with endothelial cell count greater than 1000 cells/mm2 on specular microscopy
- Best corrected visual acuity in the study eye is 20/40 or worse at study enrollment
- Patient is dissatisfied with current vision
- Patient is otherwise to be offered a corneal graft
- For females with reproductive potential, willingness to use highly effective contraception (hormonal, barrier, intrauterine device, or abstinence)
- Indication for surgery may include cataract extraction and posterior chamber intraocular lens implantation
You will not qualify if you...
- Uncontrolled glaucoma with intraocular pressure greater than 25 mmHg
- Presence of secondary corneal pathology such as infective or autoimmune keratitis
- Advanced corneal stromal edema with haze, bullae, or Descemet membrane 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 Ripasudil hydrochloride hydrate 0.4%
- Pregnant or lactating women or planning pregnancy within next 6 months
- Any other ocular condition that may prevent study participation in the opinion of the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
NorthShore University HealthSystem
Glenview, Illinois, United States, 60026
Actively Recruiting
Research Team
D
Duanny Alva, MPH
CONTACT
M
Marian Macsai, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here