Thyroid-associated ophthalmopathy
Conditions
Interventions
Control Group:Placebo
Experimental group:Teprotumumab N01 Injection
Sponsors
The Zhongshan Ophthalmic Center,Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Agree to comply with the study protocol and voluntarily sign the written informed consent form. 2.At screening, male or female participants aged 18 to 80 years (inclusive). 3.Body weight 45–100 kg (inclusive). 4.Diagnosed with TED at screening/baseline, with a disease duration of =2 years (=730 days). 5.Gorman Subjective Diplopia Score of 1–3, with a diplopia duration of =6 months (=180 days). 6.If the participant is female, she must be of non-childbearing potential, or, if of childbearing potential, have a negative serum pregnancy test at screening and agree to use effective contraception from screening through 120 days after the last dose; if the participant is male, he must agree to use effective contraception from screening through 120 days after the last dose.
Exclusion criteria
Exclusion criteria: 1.Decreased best-corrected visual acuity due to optic neuropathy (defined as a decrease in BCVA of =2 lines attributable to optic neuropathy within the past 6 months [ 3 × the upper limit of normal (ULN). 8.At screening, estimated glomerular filtration rate (GFR) = 9.0% at screening, or initiation of a new antidiabetic medication [oral or injectable] within 60 days prior to screening, or a >10% change in the dose of any currently prescribed antidiabetic medication). 10.At screening, poorly controlled hypertension (systolic blood pressure >=160 mmHg or diastolic blood pressure >=100 mmHg); or adjustment of antihypertensive medication (dose or drug class) within 30 days prior to screening; renal artery stenosis; or evidence of unstable blood pressure (including orthostatic hypotension, etc.). 11.At screening, a 12-lead electrocardiogram (ECG) shows a heart rate 100 bpm, indicates active cardiac disease, or, in the investigator’s judgment, has abnormalities that would interfere with interpretation of ECG results during follow-up; in particular, exclude QT interval corrected using Fridericia (QTcF) >450 ms in males or >470 ms i
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to Week 24 in Gorman Subjective Diplopia Score; | — |
Countries
China
Contacts
Public ContactLu Rong
The Zhongshan Ophthalmic Center,Sun Yat-sen University
Outcome results
None listed