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

Recruitingn/aAges 12 Years - 99 YearsAllClaris Biotherapeutics, Inc.
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In plain words

What the trial is, and whether it could suit you

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).

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * A photopic BCVA in the prospective study eye(s) of โ‰ค 70 letters at the Screening and Day 1 visits AND a change of โ‰ค 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.
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What it tests

  • Non-interventional
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Where

8 sites
Claris Investigative Site
Carmel, United States
Claris Investigative Site
Indianapolis, United States
Claris Investigative Site
Overland Park, United States
Claris Investigative Site
Louisville, United States
Claris Investigative Site
Minnetonka, United States
Claris Investigative Site
Portland, United States
Claris Investigative Site
Smyrna, United States
Claris Investigative Site
San Antonio, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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