CORNEA CLINICAL TRIALS

Descemet Endothelial Thickness Comparison Trial (DETECT I & II)
Study aims: 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.
Study design (clinical trial/observational study): Clinical Trial
Eligibility criteria: To be discussed directly with study team, as eligibility depends on disease severity.
Treatment arms:
DETECT I: You will be randomly assigned (by chance, like flipping a coin) 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. You will also be randomly assigned to receive topical ripasudil or topical placebo (eye drops containing no active ingredient). You have a 50/50 chance of getting either topical ripasudil or placebo regardless of the type of surgery that you receive.
DETECT II: You will be randomly assigned to undergo DSO or DMEK surgery. You have a 50/50 chance of either getting the DSO plus topical ripasudil or DMEK plus placebo.
Number of study visits: DETECT I & II: 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.
What participation involves (eg., costs/reimbursement to patient): 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. Parking fees will be reimbursed to you.
Sponsor: National Eye Institute, NIH
Dates of enrollment: September 2024- present
PI: Zeba Syed, MD
Contact person/Study coordinator: Kieran Alessi ; 215 928 3113 ; kalessi@willseye.org

A 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)
Study aims: 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.
Study design (clinical trial/observational study): Clinical Trial
Eligibility criteria:
Must be at least 8 years of age and no greater than 45 years of age at enrollment.
Contact lens wearers must agree to discontinue wearing lenses according to the lens removal instructions.
Remaining criteria to be discussed directly with study team.
Treatment arms: You will have a 50% (1 in 2) chance of receiving active treatment and a 50% (1 in 2) chance of receiving sham treatment. Regardless of which treatment you receive, if your condition worsens, you may be eligible to receive the active treatment as early as 3 months later (rescue treatment). All participants who received the sham treatment during the study will be offered the active treatment at the end of the study.
Number of study visits: 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.
What participation involves (eg., costs/reimbursement to patient): If you complete all visits you will receive a total of $750. The study treatment will be given at no cost to you, and you will not be charged for any study doctor visits, laboratory work, tests, or procedures needed for the study.
Sponsor: Epion Therapeutics, Inc.
Dates of enrollment: September 2024-May 2025
PI: Christopher Rapuano, MD
Contact person/Study coordinator: Kieran Alessi ; 215 928 3113 ; kalessi@willseye.org

A Study to Evaluate the Safety and Efficacy of KPI-012 Ophthalmic Solution in Participants with Persistent Corneal Epithelial Defect (PCED)
Study aims: 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.
Study design (clinical trial/observational study): Clinical Trial
Eligibility criteria: To be discussed directly with study team.
Treatment arms: You will be randomly assigned to 1 of 3 treatments, KPI-012 High Dose eye drops, KPI-012 Low Dose eye drops, or placebo eye drops. This is a randomized study which means you will be assigned to a study product by chance, like a flip of a coin. There will be up to approximately 90 participants in this research study. Approximately 30 participants in the study will be assigned KPI-012 High Dose, approximately 30 participants will receive KPI-012 Low Dose, and approximately 30 participants will receive placebo as the study treatment. Neither you nor your study doctor will know what treatment you are receiving, therefore this is called a double-masked study.
Number of study visits: If you are eligible to participate in this study, there are a total of eleven (11) study visits required: nine (9) clinic study visits, and two (2) non-clinic visits (by telephone).
What participation involves (eg., costs/reimbursement to patient): KPI-012 study drug and all study assessments will be provided at no cost to you.
Sponsor: KALA BIO, Inc.
Dates of enrollment: July 2023- Present
PI: Christopher Rapuano, MD
Contact person/Study coordinator: Kieran Alessi ; 215 928 3113 ; kalessi@willseye.org