A Study to Evaluate the Safety and Efficacy of KPI-012 Ophthalmic Solution in Participants with Persistent Corneal Epithelial Defect (PCED)
PI: Christopher Rapuano, MD
Description:
This is a research study to evaluate the safety and effectiveness of KPI-012 compared to placebo in participants who have a documented clinical diagnosis of PCED. Your participation may last up to approximately 35 weeks. Study drug KPI-012 instillation as ophthalmic drops.
There are 11 visits, 9 of which take place at Wills Eye Hospital and 2 include blood draws. The other 2 visits are done by telephone.
KPI-012 study drug and all study assessments will be provided at no cost to you. For your time and inconvenience related to your participation in this study, you will be paid for the study visits you complete.
Clinical Study Coordinator: Kieran Alessi, kalessi@willseye.org
Descemet Endothelial Thickness Comparison Trial (DETECT I & II)
PI: Zeba Syed, MD
Description:
The purpose of this research is to identify the best treatment for patients with diseased or damaged endothelium requiring corneal transplant. Currently, it is not known which type of transplant is the best. In this study we will determine differences in visual outcomes between two types of corneal transplant surgeries, ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK) and Descemet membrane endothelial keratoplasty (DMEK), and to determine the effect of rho-kinase inhibitors on endothelial cell loss.
If you decide to take part in this research study, you will be randomly assigned to undergo DSAEK or DMEK surgery. You have a 50/50 chance of either getting the DSAEK or DMEK surgery. Both types of surgeries are in common practice for corneal transplantation. It is not clear that one is better than the other.
You will be randomly assigned to receive topical ripasudil or topical placebo. You have a 50/50 chance of getting either topical ripasudil or placebo regardless of the type of surgery that you receive. You will be in this study for two years. You will be asked to complete 7 study visits, with each visit lasting up to 2-3 hours. You will be asked to follow up with the surgeon for post-operative checkups 3, 6, 12, and 24 months after your surgery. At these visits, your doctor will complete physical examinations of your eye, and collect images of your eye.
The study drug and study-related tests and procedures that are not part of the usual standard of care for your condition will be provided to you free of charge while you are participating in this study.
All aspects of usual medical care will continue to be provided to you according to the terms of your medical insurance policy, which may include copayments, coinsurance, and deductibles.
Clinical Study Coordinator: Kieran Alessi, kalessi@willseye.org
Multicenter, Randomized, Double-Masked, Sham-Controlled, Parallel-Group Phase 3 Study to Evaluate the Efficacy and Safety of Epithelium-On Corneal Cross-linking in Subjects 8 to 45 Years of Age with Keratoconus (APRICITY-A)
PI: Christopher Rapuano, MD
Description:
The main purpose of this study is to learn how well Ribostat solution followed by UVA light exposure works to treat the symptoms of keratoconus in participants 8 to 45 years of age and how safe it is compared to placebo followed by sham light exposure. The placebo is a solution that does not have any Ribostat; it only contains ingredients that do not have any medicinal effect on the eye. The sham light is a light that does not have any UVA light; it is only a light that does not have any effect on the eye. Researchers use a placebo to see if Ribostat works better or is safer than using nothing, and a sham light to see if the UVA light works better or is safer than using nothing.
You will be in this study for approximately 1 year and 2 weeks, and you will need to come to the Wills Eye Cornea Service at least 8 times over this period.
You will receive a stipend for participating in the study to compensate you for your time and travel expenses.
Clinical Study Coordinator: Kieran Alessi, kalessi@willseye.org