RecruitingNCT07636590

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

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

Sponsor

Claris Biotherapeutics, Inc.

Enrollment

500 participants

Start Date

May 22, 2026

Study Type

OBSERVATIONAL

Conditions

Limbal Stem Cell Deficiency

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

Min Age: 12 YearsMax Age: 99 Years

Inclusion Criteria4

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 Criteria3

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)

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