MTHDLOGY0011 Study for Limbal Stem Cell Deficiency

(Enrolling both Limbal Stem Cell Deficiency patients and healthy volunteers!)

PI: Christopher Rapuano, MD

Description:

The outermost layer of the cornea, the corneal epithelium, is continuously regenerated by a population of stem cells located in the corneal limbus. In the absence of these limbal stem cells, the corneal epithelium develops irregularities that cause periodic pain and vision loss. This condition is known as limbal stem cell deficiency (LSCD).

The aim of the study is to determine new methods to measure LSCD.  This information can help determine disease severity and can be applied to future studies on new treatments for LSCD. Another goal is to learn about the natural history of the disease and the benefits from the currently available treatments.

The study consists of two parts.

Part 1 involves patients with LSCD who complete one study visit that includes an ocular examination and imaging of the eye.  This part is nearly complete.

Part 2 includes people with mild/moderate LSCD and healthy volunteers who will complete 3 study visits in one year; people with severe LSCD will also be recruited and will complete 3 in-office visits in 1 year followed by 4 annual visits that are completed remotely.  All participants in Part 2 will undergo an ocular exam and ocular imaging. Those with LSCD will also have minimally invasive impression cytology and a blood draw.

This study is sponsored by Novartis.

*ELIGIBILITY

• Part 1 and Part 2- LSCD participants
• Male and female participants 18 years of age or older
• The diagnosis of LSCD (of any severity) in at least one eye
• No active ocular infection
• No participation in another clinical trial.
• Part 2- Healthy volunteers will meet all of the above criteria except for LSCD

*Additional eligibility and ineligibility criteria exist, which will be discussed with the study coordinator.

CONTACT

To learn more about the study, please contact:

Kieran Alessi, Study Coordinator
Email: kalessi@willseye.org
Phone: (215) 928-4712