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NCT07636590Recruiting

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

Claris Biotherapeutics, Inc.

Start Date

5/22/2026

Completion Date

3/1/2028

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

Age Range: 12 years to 99 years

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.

Interventions

OTHER

Non-interventional

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Conditions

Limbal Stem Cell Deficiency

Locations

Claris Investigative Site

Carmel, Indiana 46290

United States

Claris Investigative Site

Indianapolis, Indiana 46260

United States