A Phase 2 interventional study of Glanatec and Optive, Ophthalmic Solution in Fuchs Endothelial Dystrophy, sponsored by Michael D. Straiko, MD. Recruiting at 1 site in United States. Open to participants aged 30 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-03-20.
Sponsored by Michael D. Straiko, MD · Phase 2, Interventional, and Treatment
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.
Ripasudil 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.
The 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.
92 studies on the registry are indexed under Fuchs' Endothelial Dystrophy; 27 are open to participants now.
This study's planned enrollment of 72 is above the median of 50 across 62 interventional studies indexed under Fuchs' Endothelial Dystrophy.
Browse Fuchs' Endothelial Dystrophy studies →This is the only study on the registry with Michael D. Straiko, MD as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Glanatec eye drops will be administered 6x per day for 2-4 weeks
Drug: Glanatec · Procedure: Descemet Membrane Endothelial Keratoplasty
Optive artificial tears will be administered 6x per day for 2-4 weeks
Drug: Optive, Ophthalmic Solution · Procedure: Descemet Membrane Endothelial Keratoplasty
Rho kinase Inhibitor
Also known as: Ripasudil
artificial tears (placebo)
Also known as: Optive, artificial tears
Partial thickness corneal transplant that replaces only the diseased corneal endothelium and descemet membrane of the recipient.
Also known as: DMEK
Time to corneal clearance
Slit lamp examinations and corneal OCT measurements will be taken in a longitudinal fashion to compare corneal clearance and stabilization.
Time frame: 6 months
Best corrected visual acuity
Longitudinal best corrected visual acuity tests will be performed to compare the time course of best vision attained and reported in Snellen units.
Time frame: 6 months
Endothelial cell density
Specular imaging will be conducted at 3 and 6 month postoperative to compare endothelial cells loss.
Time frame: 6 months
Post surgery complications
Number of graft detachments requiring a re-bubble procedure and number of graft failures will be recorded.
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2019 (actual). Primary completion is estimated for Feb 2025, 70 months after the start.
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Studies of the drug tested here: K-115
Fuchs' Endothelial Dystrophy →