AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Limbal Stem Cell Deficiency

RecruitingPhase 1Ages 18 Years - anyAllClaris Biotherapeutics, Inc.
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

This study will enroll subjects with qualifying limbal stem cell deficiency (LSCD). All subjects will receive CSB-001 investigational drug in either one or both study eyes. The study is comprised of two identical phases (Dosing Phase I and II) of test article dosing separated by a 31- to 40-day period, the Dosing Holiday, where no test article is administered. Dosing Phase II is followed by an observational, noninterventional phase (Observation Phase).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Have an area of the central 5 mm zone of cornea affected, presence of at least one clinical sign observed by slit-lamp examination with white light and/or cobalt blue light, fluorescein, and a Wratten filter, and at least one clinical sign observed with AS-OCT. * If dosing with Acthar at time of Screening Visit, must have a history of stable dosing for approximately 8 weeks, plan to maintain the same Acthar treatment dose and regimen, and have demonstrated little to no improvement in severity of LSCD. * Sponsor written confirmation of qualifying LSCD diagnosis. * Inflammation associated with LSCD or other non-infectious inflammation that will not interfere with subject's participation. Exclusion Criteria: * Any active ocular infection (bacterial, viral, fungal, or protozoan) in either eye. * Ocular surgery within 30 days of Day 0 where investigator assesses that healing is not considered complete/stable. * Planned ocular surgery on or before Week 20 visit. * Presence or history of any ocular or systemic disorder, condition, or procedure that might hinder the efficacy of the study treatment or its evaluation, or could interfere with the interpretation of study results, in the opinion of the investigator. Note: Other inclusion/exclusion criteria apply.
๐Ÿ’Š

What it tests

  • CSB-001 Ophthalmic Solution 0.1%
๐Ÿ“

Where

6 sites
Loma Linda University Eye Institute
Loma Linda, United States
Midwest Cornea Associates, LLC
Carmel, United States
Francis Price Jr, MD
Indianapolis, United States
Minnesota Eye Consultants
Minnetonka, United States
Legacy Devers Eye Institute
Portland, United States
Stuart A. Terry, MD PA
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.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy