Recruiting

Glanatec

Sponsor:

Marian Macsai, MD

Code:

NCT03249337

Conditions

Fuchs' Endothelial Dystrophy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Ripasudil hydrochloride hydrate 0.4% ophthalmic solution

Study Details

Brief summary:

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

Fuchs' Endothelial Dystrophy

Study ID

NCT03249337

Start date

Dec 6, 2017

Status verified date

Aug, 2021

Completion date

Dec, 2021

Anticipated

Primary completion date

Dec, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • • 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
  • Ability to apply eye drop medication and willing to adhere to 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 2-4 on the Krachmer grading scale
  • Presence of central guttae deemed by the investigator to be the chief cause of visual symptoms, rather than cataract or corneal stromal edema
  • Clear peripheral cornea with an endothelial cell count >1000 cells/mm2 on specular microscopy
  • Best corrected visual acuity in the study eye is 20/40 or worse at study enrollment
  • The patient is dissatisfied with current vision
  • The patient is otherwise to be offered a corneal graft
  • For females with reproductive potential, willingness to use highly effective contraception (e.g., hormonal contraception, barrier contraception, intrauterine device, or abstinence).
  • Indication for surgery may include cataract extraction and posterior chamber intraocular lens implantation

Exclusion Criteria:

  • • 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
  • Prior endothelial keratoplasty
  • Aphakic in study eye.
  • Allergy to any component of the Ripasudil hydrochloride hydrate 0.4% that will be used in the course of the study
  • For women of child-bearing potential: Pregnant or lactating, or planning to become pregnant within the next 6 months.
  • Any other ocular condition that, in the opinion of the investigator, may preclude the subject from study participation.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Glanatec(R) 3 times a day

active comparator: Glanatec (R) 6 times a day

Interventions

Ripasudil hydrochloride hydrate 0.4% ophthalmic solution

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

Primary outcome measure

  • Corneal Clearing [ Time Frame: 12 months ]
  • pachymetry measurement [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Duanny Alva, MPH

847-570-1783dalva@northshore.org

Marian Macsai, MD

847-657-1936mmacsai@northshore.org

Locations

NorthShore University HealthSystem

Recruiting

Glenview, Illinois, United States, 60026

Contacts

Duanny Alva, MPH

847-570-1783dalva@northore.org

Principal Investigator:

Marian Macsai, MD

More Information

Sponsor

Marian Macsai, MD

Last update posted

Aug 11, 2021

Last verified

Aug, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Marian Macsai, MD on 2021-08-11.