ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 31 of 333 for:    "Eye Diseases, Hereditary" OR "Lenz microphthalmia syndrome"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03249337
Recruitment Status : Recruiting
First Posted : August 15, 2017
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
Marian Macsai, MD, NorthShore University HealthSystem

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.


Condition or disease Intervention/treatment Phase
Fuchs' Endothelial Dystrophy Drug: Ripasudil hydrochloride hydrate 0.4% ophthalmic solution Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study For Efficacy And Safety Of Glanatec® Opthalmic Solution 0.4% On Corneal Edema And Endothelial Cell Counts In Subjects With Fuchs Endothelial Dystrophy Undergoing Descemet Stripping Without Endothelial Keratoplasty
Actual Study Start Date : December 6, 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Glanatec(R) 3 times a day Drug: 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
Other Name: Glanatec

Active Comparator: Glanatec (R) 6 times a day Drug: 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
Other Name: Glanatec




Primary Outcome Measures :
  1. Corneal Clearing [ Time Frame: 12 months ]
    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

  2. pachymetry measurement [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. Visual Acuity [ Time Frame: 12 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 91 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
    • Psuedophakic 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03249337


Contacts
Contact: Mira Shiloach, M.S 847-657-1750 mshiloach@northshore.org
Contact: Marian Macsai, MD 847-657-1936 mmacsai@northshore.org

Locations
United States, Illinois
NorthShore University HealthSystem Recruiting
Glenview, Illinois, United States, 60026
Contact: Mira Shiloach, M.Sc.    847-657-1750    mshiloach@northore.org   
Principal Investigator: Marian Macsai, MD         
Sponsors and Collaborators
Marian Macsai, MD

Responsible Party: Marian Macsai, MD, Chief Ophthalmology, NorthShore University HealthSystem
ClinicalTrials.gov Identifier: NCT03249337     History of Changes
Other Study ID Numbers: EH17-320
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Fuchs' Endothelial Dystrophy
Corneal Dystrophies, Hereditary
Corneal Diseases
Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Pharmaceutical Solutions
Ophthalmic Solutions