Multi-Center, Prospective, Non-Interventional Study in Subjects With Limbal Stem Cell Deficiency
Purpose
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).
Condition
- Limbal Stem Cell Deficiency
Eligibility
- Eligible Ages
- Between 12 Years and 99 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Non-interventional | No product administration. |
|
Recruiting Locations
Claris Investigative Site
Carmel, Indiana 46290
Carmel, Indiana 46290
Contact:
Study Coordinator
Study Coordinator
Claris Investigative Site
Indianapolis, Indiana 46260
Indianapolis, Indiana 46260
Contact:
Study Coordinator
Study Coordinator
More Details
- Status
- Recruiting
- Sponsor
- Claris Biotherapeutics, Inc.