Multi-Center, Prospective, Non-Interventional Study in Subjects With Limbal Stem Cell Deficiency

Recruiting now

Conditions studied: Limbal Stem Cell Deficiency

In brief

The goal of this non-interventional, observational study is to describe the natural history, clinical course, and management patterns of subjects with limbal stem cell deficiency (LSCD).

Key facts

Study ID

NCT07636590

Run by

Claris Biotherapeutics, Inc.

People needed

500

Starts

2026-05-22

Expected to finish

2028-03-01

Last updated by the study team

2026-08-06

Who can join

Age: 12 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A photopic BCVA in the prospective study eye(s) of ≤ 70 letters at the Screening and Day 1 visits AND a change of ≤ 10 letters in photopic BCVA at Day 1 compared to the Screening Visit
• Qualifying LSCD diagnosis in the study eye(s) prior to enrollment at Day 1
• Written confirmation that exclusions on retinal findings are met in the study eye(s) prior to enrollment at Day 1
• Inflammation associated with LSCD or other non-infectious inflammation (e.g., dry eye, ocular rosacea, and blepharitis) that will not interfere with the subject's participation in the opinion of the investigator is permitted.

You may not qualify if…

• Any active ocular infection in either eye at either the Screening or Day 1 visits
• Active sterile iritis or uveitis in either eye at Screening or Day 1 visits
• Screening visit retinal exam finding, in the opinion of the investigator, that would limit potential for visual acuity gain in the study eye(s)
• Note: Other inclusion/exclusion criteria apply.

Where it is running

• Claris Investigative Site — Carmel, Indiana, United States (enrolling)
• Claris Investigative Site — Indianapolis, Indiana, United States (enrolling)
• Claris Investigative Site — Overland Park, Kansas, United States (enrolling)
• Claris Investigative Site — Louisville, Kentucky, United States (enrolling)
• Claris Investigative Site — Minnetonka, Minnesota, United States (enrolling)
• Claris Investigative Site — Portland, Oregon, United States (enrolling)
• Claris Investigative Site — Smyrna, Tennessee, United States (enrolling)
• Claris Investigative Site — San Antonio, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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