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An Open-label, Phase 1/2 Trial of Gene Therapy 4D-125 in Males with X-linked Retinitis Pigmentosa (XLRP) Caused by Mutations in the RPGR Gene
This is a multicenter study with two parallel parts: an observational Natural History Cohort and an open-label, prospective interventional trial in males with non-syndromic XLRP due to mutations in RPGR. The target population is restricted to avoid confounding atypical presentation in fema... Protocol #20-0130 |
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A Multi-Center, Randomized, Double-Masked, Vehicle-Controlled, Parallel-Group, Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Stage 2 and 3 Neurotrophic Keratitis Subjects
Patients diagnosed with stage 2 (persistent epithelial defect) or stage 3 (corneal ulcer) Neurotrophic Keratitis (NK) will take part in this study. Neurotrophic Keratitis (also called neurotrophic keratopathy) is a rare disease of the cornea that occurs when the nerves to the cornea do not... Protocol #21-3923 |
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An Open-label Extension Study for Participants who Completed Study IMVT-1401-3201 or Study IMVT-1401-3202 to Assess the Efficacy and Safety of Batoclimab for the Treatment of Thyroid Eye Disease (TED)
Study IMVT-1401-3203 is a 2-cohort extension study for eligible participants completing the Week 24 visit on the feeder studies, IMVT-1401-3201 or IMVT-1401-3202. Participants will be assessed as proptosis responders or non-responders at Week 24 in the feeder studies. Based upon this as... Protocol #22-2037 Location: University of Colorado Hospital |
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IMVT-1401-3201: A Phase 3, Multi-center, Randomized, Quadruple-masked, Placebo-controlled Study of Batoclimab for the Treatment of Participants with Active Thyroid Eye Disease (TED)
Study IMVT-1401-3201 is a Phase 3, multi-center, randomized, quadruple‑masked (Sponsor, Investigator, assessor, and participant), placebo‑controlled study was designed to assess the efficacy and safety of batoclimab in adult participants with active, moderate to severe TED. The study durat... Protocol #22-1591 Location: University of Colorado Hospital |
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A Multicenter Phase 2b Randomized, Double-Masked, Placebo-Controlled Dose-Ranging Study of TOUR006 in Participants with Thyroid Eye Disease
The purpose of this dose ranging study is to study the efficacy and safety of TOUR006 SC compared with placebo in participants with moderate to severe TED.... Protocol #23-1181 Location: University of Colorado Hospital |
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A MULTICENTER, RANDOMIZED, DOUBLE-MASKED, SHAM-CONTROLLED,
PARALLEL-GROUP PHASE 3 STUDY TO EVALUATE THE EFFICACY AND
SAFETY OF EPITHELIUM-ON CORNEAL CROSS-LINKING IN SUBJECTS 8 TO
45 YEARS OF AGE WITH KERATOCONUS (APRICITY-B)
To evaluate the efficacy of the riboflavin-sodium iodide solution followed by ultraviolet A (UVA) exposure and epithelium-on corneal crosslinking (CXL) assessed by visual acuity measurement in subjects with keratoconus.... Protocol #23-1425 Location: University of Colorado Hospital |