Actively Recruiting
Pilot Study of Glanatec4 Ophthalmic Solution 0.4% for Corneal Edema and Endothelial Cell Counts in Fuchs Endothelial Dystrophy After Descemet Stripping
Led by Marian Macsai, MD · Updated on 2021-08-11
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether the drug Glanatec4, approved in Japan for glaucoma and ocular hypertension, can be used safely and effectively in patients with Fuchs endothelial dystrophy (FED) who have undergone a descemet stripping procedure without endothelial keratoplasty. This study aims to provide enough proof of concept to support Glanatec4 as a treatment option for clearing corneal cells in FED patients who otherwise would need a corneal transplant. Participants receive an ophthalmic solution of Ripasudil hydrochloride hydrate 0.4%, administered either three or six times daily in the affected eye. The study is randomized and compares these two dosing schedules to evaluate the drug's effects over a 12-month period. The treatment focuses on corneal clearing and endothelial cell counts without requiring corneal transplantation. During the study, participants will be monitored through pachymetry measurements and corneal clearing assessments at 12 months, along with evaluations of visual acuity. Patients must adhere to the medication regimen and attend study visits as scheduled. The research team will track safety and effectiveness outcomes, with the total participation lasting up to one year.
CONDITIONS
Brief 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 90 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 adhere to study medication regimen
- Diagnosed with Fuchs endothelial dystrophy clinically and on confocal microscopy
- Pseudophakic Fuchs endothelial dystrophy with posterior capsule supported, suture-fixated, or sulcus-supported posterior chamber intraocular lens
- Fuchs dystrophy grades 2-4 on the Krachmer grading scale
- Presence of central guttae as the main cause of visual symptoms, not cataract or corneal stromal edema
- Clear peripheral cornea with endothelial cell count greater than 1000 cells/mm2
- Best corrected visual acuity in the study eye is 20/40 or worse
- 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
- Indication for surgery may include cataract extraction and posterior chamber intraocular lens implantation
You will not qualify if you...
- Uncontrolled glaucoma (intraocular pressure over 25 mmHg)
- Presence of secondary corneal pathology such as infective or autoimmune keratitis
- Advanced corneal stromal edema with haze, bullae, or Descemet's membrane folds
- History of herpes simplex virus or cytomegalovirus keratitis
- Prior endothelial keratoplasty
- Aphakic in the study eye
- Allergy to any component of Ripasudil hydrochloride hydrate 0.4%
- For women of child-bearing potential: pregnant, lactating, or planning pregnancy within 6 months
- Any other ocular condition that may prevent study participation according to investigator opinion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants apply the Ripasudil hydrochloride hydrate 0.4% ophthalmic solution to the study eye either three or six times per day as randomized.
Regular visits to assess treatment effects and safety
Trial Site Locations
Total: 1 location
1
NorthShore University HealthSystem
Glenview, Illinois, United States, 60026
Actively Recruiting
Research Team
D
Duanny Alva, MPH
M
Marian Macsai, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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