Phase
Condition
Dry Eye Disease
Treatment
linsitinib
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject who completed the 24-week double-mask period of VGN-TED-301 and areproptosis non-responders (< 2 mm reduction in proptosis in the study eye) at Week 24of VGN-TED-301 study or proptosis responders at Week 24 who relapse during theFollow-Up period of VGN-TED-301
Subject has not received any treatment for TED since Week 24 of VGN-TED-301
Subjects must be euthyroid with the participant's baseline disease under control orhave mild hypo- or hyperthyroidism (defined as free thyroxine [FT4] and freetriiodothyronine levels [FT3] <50% above or below the normal limits) at Baseline.Every effort should be made to correct mild hypo- or hyperthyroidism promptly andmaintain the euthyroid state for the duration of the clinical trial
Does not require immediate ophthalmic surgery, radiotherapy to orbits or otherophthalmological intervention at the time of Baseline and is not planning for anysuch treatment during the course of the study
Exclusion
Exclusion Criteria:
- The exclusion criteria of protocol VGN-TED-301 also apply to this extension study.
Study Design
Connect with a study center
Bascom Palmer Eye Institute
Miami, Florida 33136
United StatesActive - Recruiting
West Virginia University Eye Institute
Morgantown, West Virginia 26506
United StatesActive - Recruiting
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