Fraser Eye Care Center | Fraser, MI
Status and phase
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About
This is a clinical trial assessing the efficacy, safety, and tolerability of an investigational drug, VRDN-003, in participants with chronic Thyroid Eye Disease (TED).
Full description
This is a randomized (meaning participants will be assigned to study arms by chance), double-masked (meaning study doctor and participant will not know which study arm participant is assigned to), placebo-controlled study that will include participants with chronic TED. The key objectives of this study are to determine if VRDN-003 is efficacious, safe and tolerable when administered as subcutaneous/SC injections every 4 weeks or every 8 weeks compared to placebo in participants with chronic TED.
Participants who do not have a meaningful response at Week 24 may be eligible to receive additional subcutaneous injections of VRDN-003.
Enrollment
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Inclusion criteria
Exclusion criteria
NOTE: There are additional eligibility criteria for non-responders who may receive additional injections of VRDN-003. These are described in the protocol.
Primary purpose
Allocation
Interventional model
Masking
126 participants in 3 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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