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Recruiting
NCT07636590
Multi-Center, Prospective, Non-Interventional Study in Subjects With Limbal Stem Cell Deficiency
Conditions: Limbal Stem Cell Deficiency
Sex: All
Ages: 12 Years – 99 Years
Healthy volunteers: No
Enrollment: 500
Sponsor: Claris Biotherapeutics, Inc.
Location: Claris Investigative Site Carmel Indiana
Summary
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).
Eligibility Criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Source: ClinicalTrials.gov (NCT07636590). StuddyBuddy aggregates publicly available trial information.