Thyroid eye disease
Conditions
Brief summary
Overall Response Rate comprised of Proptosis Responder Rate in the most proptotic eye at 3 weeks post the fifth IV infusion and Clinical Activity Responder Rate in the most proptotic eye at 3 weeks post the fifth IV infusion., Safety Endpoint: Adverse Events (AEs) and Serious Adverse Events (SAEs) will be monitored and recorded throughout the duration of the study. All clinically significant changes in other safety measurements will be recorded as AEs.
Detailed description
Change from baseline in proptosis for the most proptotic eye at Week 15., Proptosis change from baseline, general and measured by exophtalmometer and responder rate at Week 15., Diplopia Responder and Resolution Rate (i.e., reduction in Diplopia Score to 0 from baseline for participants with baseline Diplopia Score >0) at Week 15.
Interventions
DRUGSODIUM CHLORIDE
Sponsors
Viridian Therapeutics Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in proptosis for the most proptotic eye at Week 15., Proptosis change from baseline, general and measured by exophtalmometer and responder rate at Week 15., Diplopia Responder and Resolution Rate (i.e., reduction in Diplopia Score to 0 from baseline for participants with baseline Diplopia Score >0) at Week 15. | — |
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate comprised of Proptosis Responder Rate in the most proptotic eye at 3 weeks post the fifth IV infusion and Clinical Activity Responder Rate in the most proptotic eye at 3 weeks post the fifth IV infusion., Safety Endpoint: Adverse Events (AEs) and Serious Adverse Events (SAEs) will be monitored and recorded throughout the duration of the study. All clinically significant changes in other safety measurements will be recorded as AEs. | — |
Countries
France, Germany, Hungary, Italy, Poland, Spain
Outcome results
None listed