Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-01-04 @ 9:15 PM
Study NCT ID:
NCT03813056
Status:
RECRUITING
Last Update Posted:
2024-03-20
First Post:
2019-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ripasudil for Enhanced Corneal Clearing Following Descemet Membrane Endothelial Keratoplasty in Fuchs' Dystrophy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005642', 'term': "Fuchs' Endothelial Dystrophy"}], 'ancestors': [{'id': 'D003317', 'term': 'Corneal Dystrophies, Hereditary'}, {'id': 'D003316', 'term': 'Corneal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C584679', 'term': 'K-115'}, {'id': 'D009883', 'term': 'Ophthalmic Solutions'}, {'id': 'D065346', 'term': 'Lubricant Eye Drops'}], 'ancestors': [{'id': 'D019999', 'term': 'Pharmaceutical Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D054327', 'term': 'Lubricants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-19', 'studyFirstSubmitDate': '2019-01-19', 'studyFirstSubmitQcDate': '2019-01-19', 'lastUpdatePostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to corneal clearance', 'timeFrame': '6 months', 'description': 'Slit lamp examinations and corneal OCT measurements will be taken in a longitudinal fashion to compare corneal clearance and stabilization.'}], 'secondaryOutcomes': [{'measure': 'Best corrected visual acuity', 'timeFrame': '6 months', 'description': 'Longitudinal best corrected visual acuity tests will be performed to compare the time course of best vision attained and reported in Snellen units.'}, {'measure': 'Endothelial cell density', 'timeFrame': '6 months', 'description': 'Specular imaging will be conducted at 3 and 6 month postoperative to compare endothelial cells loss.'}, {'measure': 'Post surgery complications', 'timeFrame': '6 months', 'description': 'Number of graft detachments requiring a re-bubble procedure and number of graft failures will be recorded.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fuchs Endothelial Dystrophy']}, 'descriptionModule': {'briefSummary': "Recently, published literature has reported that performing a descemetorhexis in combination with topical Rho kinase (ROCK) inhibitor therapy was successful in clearing edematous corneas in patients with Fuchs Endothelial Corneal Dystrophy.\n\nRipasudil hydrochloride hydrate( Glanatec ophthalmic solution 0.4%), a potent ROCK inhibitor, has been approved in Japan since 2014 for ocular use in the treatment of glaucoma. Ripasudil acts as an IOP-lowering drug by affecting aqueous outflow through the trabecular meshwork and Schlemm's canal.\n\nThe goal of this study is to test the potential benefits of Ripasudil therapy administered after Descemet Membrane Endothelial Keratoplasty (DMEK) surgery. We believe that performing a standard DMEK surgery in combination with Ripasudil treatment in patients with Fuchs Endothelial Corneal Dystrophy could accelerate endothelial cell healing and clear edematous corneas faster, with less post-operative complications."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed clinically with Fuchs endothelial corneal dystrophy by the study investigator.\n* Phakic or pseudophakic with posterior capsule supported, suture-fixated, or sulcus-supported posterior chamber intraocular lens.\n* Fuchs dystrophy grades 2-5 on the Krachmer grading scale.\n* Presence of central guttae and/or stromal edema being the primary cause of decreased vision.\n* The peripheral cornea to the central 6mm is devoid of guttata changes.\n* Best corrected visual acuity in the study eye is 20/40 or worse with glare testing at study enrollment.\n\nExclusion Criteria:\n\n* Uncontrolled glaucoma (IOP \\>25 mmHg).\n* Presence of secondary corneal pathology such as infective or autoimmune keratitis.\n* Advanced corneal stromal edema with bullae on slit-lamp biomicroscopy.\n* History of herpes simplex virus or cytomegalovirus keratitis.\n* Prior penetrating keratoplasty.\n* Aphakic in study eye.\n* Allergy to any component of the Ripasudil hydrochloride hydrate 0.4% that will be used in the course of the study.\n* Tubes or trabeculectomy from prior glaucoma surgery.'}, 'identificationModule': {'nctId': 'NCT03813056', 'briefTitle': "Ripasudil for Enhanced Corneal Clearing Following Descemet Membrane Endothelial Keratoplasty in Fuchs' Dystrophy", 'organization': {'class': 'OTHER', 'fullName': 'Legacy Health System'}, 'officialTitle': "A Phase II, Interventional, Double-blind, Single-center Study of the Effects of Ripasudil on Cornea Clearing After Descemet Membrane Endothelial Keratoplasty in Subjects With Fuchs' Endothelial Corneal Dystrophy", 'orgStudyIdInfo': {'id': 'RDMEK-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glanatec', 'description': 'Glanatec eye drops will be administered 6x per day for 2-4 weeks', 'interventionNames': ['Drug: Glanatec', 'Procedure: Descemet Membrane Endothelial Keratoplasty']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Control', 'description': 'Optive artificial tears will be administered 6x per day for 2-4 weeks', 'interventionNames': ['Drug: Optive, Ophthalmic Solution', 'Procedure: Descemet Membrane Endothelial Keratoplasty']}], 'interventions': [{'name': 'Glanatec', 'type': 'DRUG', 'otherNames': ['Ripasudil'], 'description': 'Rho kinase Inhibitor', 'armGroupLabels': ['Glanatec']}, {'name': 'Optive, Ophthalmic Solution', 'type': 'DRUG', 'otherNames': ['Optive, artificial tears'], 'description': 'artificial tears (placebo)', 'armGroupLabels': ['Placebo Control']}, {'name': 'Descemet Membrane Endothelial Keratoplasty', 'type': 'PROCEDURE', 'otherNames': ['DMEK'], 'description': 'Partial thickness corneal transplant that replaces only the diseased corneal endothelium and descemet membrane of the recipient.', 'armGroupLabels': ['Glanatec', 'Placebo Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Alex J Bauer, B.S.', 'role': 'CONTACT', 'email': 'alex@visiongift.org', 'phone': '503-413-8377'}], 'facility': 'Devers Eye Institute', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'centralContacts': [{'name': 'Alex J Bauer, B.S.', 'role': 'CONTACT', 'email': 'alex@visiongift.org', 'phone': '503-413-8377'}, {'name': 'Michael D Straiko, M.D.', 'role': 'CONTACT', 'email': 'mike.straiko@gmail.com', 'phone': '503-413-8032'}], 'overallOfficials': [{'name': 'Michael D Straiko, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Devers Eye Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Michael D. Straiko, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lions VisionGift Research', 'class': 'OTHER'}, {'name': 'Eye Bank Association of America', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Director of Corneal Services, Devers Eye Institute', 'investigatorFullName': 'Michael D. Straiko, MD', 'investigatorAffiliation': 'Legacy Health System'}}}}