Ripasudil Treatment after Simultaneous DSO and Cataract Surgery in Subjects with FECD
Research type
Research Study
Full title
A Double-Masked, Randomized, Placebo-Controlled, Parallel-Group, 12-Week Administration With Two-Week Gradual Dose Taper Phase and 38-Week Follow-Up Phase, Phase 3 Study to Investigate the Safety and Efficacy of Ripasudil (K-321) Eye Drops After Simultaneous Cataract Surgery and Descemetorhexis in Subjects with Fuchs Endothelial Corneal Dystrophy
IRAS ID
1007436
Contact name
Ross Laderman
Contact email
Sponsor organisation
Kowa Research Institute, Inc.
Research summary
In the normal adult human cornea, the inner layer is made of thousands of small pump cells called endothelial cells, which pump fluid out of the cornea so that it can remain clear and preserve corneal transparency. Fuchs Endothelial Corneal Dystrophy (FECD) is characterised by progressive loss of these corneal endothelial cells. This can cause the cornea to swell and become cloudy, and thus cause blurry vision.
FECD is currently treated by a variety of keratoplasty techniques including full and partial thickness (endothelial) corneal transplants. However corneal transplants are associated with risks of graft detachment, graft failure, immune rejection and infection. In addition there is current global shortage of donor corneas. In recent years a procedure called descemetorhexis has been proposed as a treatment for FECD, where the area of abnormal endothelial pump cells is removed, but no corneal tissue is transplanted. K-321 is an eye drop that has been reported to improve visual outcomes in FECD patients undergoing descemetorhexis in several small studies.
As such, the Sponsor Kowa Research Institute designed this Phase 3 study with a purpose to evaluate the safety and efficacy of K-321 eye drops in patients with FECD after simultaneous cataract surgery and descemetorhexis. About 100 participants will participate in this study. This study will be conducted at multiple sites in several countries. The study will last for 52 weeks (12-week treatment administration, 2-week gradual dose taper phase and 38-week follow-up period). Participants will receive either K-321 eye drops or placebo (dummy) eye drops, but neither the participant nor study investigators will know which drop they are receiving.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
23/NE/0069
Date of REC Opinion
30 Aug 2023
REC opinion
Further Information Favourable Opinion