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

Официальное название

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

Обзор

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).

Вмешательства

• Другое Non-interventional
  Non-interventional

Первичные конечные точки

• Natural Progression of LSCD as Assessed by Changes in Patient Reported Outcomes [Срок оценки: Screening through Week 84]
• Natural Progression of LSCD as Assessed by Functional Changes (Photophobic BCVA) [Срок оценки: Screening through Week 84]
• Natural Progression of LSCD as Assessed by Functional Changes (Low-luminance BCVA) [Срок оценки: Screening through Week 84]
• Natural Progression of LSCD as Assessed by Functional Changes (Low-contrast BCVA) [Срок оценки: Screening through Week 84]
• Natural Progression of LSCD as Assessed by Functional Changes (Contrast Sensitivity) [Срок оценки: Screening through Week 84]
• Natural Progression of LSCD as Assessed by Anatomical/Structural Changes [Срок оценки: Screening through Week 84]

Вторичные конечные точки (7)

• Changes that May be Correlated with LSCD as Assessed by Functional Changes (Corneal Sensitivity) [Срок оценки: Screening through Week 84]
• Changes that May be Correlated with LSCD as Assessed by Anatomical Changes (Corneal Topography/Tomography) [Срок оценки: Screening through Week 84]
• Changes that May be Correlated with LSCD as Assessed by Anatomical Changes (Epithelial Defect Frequency) [Срок оценки: Screening through Week 84]
• Changes that May be Correlated with LSCD as Assessed by Anatomical Changes (Palisades of Vogt Crypts) [Срок оценки: Screening through Week 84]
• Changes that May be Correlated with LSCD as Assessed by Anatomical Changes (Epithelial and Total Corneal Thickness) [Срок оценки: Screening through Week 84]
• Changes that May be Correlated with LSCD as Assessed by Anatomical Changes (Pannus) [Срок оценки: Screening through Week 84]
• Changes that May be Correlated with LSCD as Assessed by Changes Ocular and Systemic Health Outcome Measures [Срок оценки: Screening through Week 84]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 8 центров

• Claris Investigative Site — Carmel
• Claris Investigative Site — Indianapolis
• Claris Investigative Site — Overland Park
• Claris Investigative Site — Louisville
• Claris Investigative Site — Minnetonka
• Claris Investigative Site — Portland
• Claris Investigative Site — Smyrna
• Claris Investigative Site — San Antonio

Идентификаторы

NCT: NCT07636590 · CSB-C26-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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