A multicenter clinical study to evaluate the efficacy and safety of IBI311 in subjects with inactive thyroid eye disease. The study consists of two parts, with a maximum duration of approximately 64 weeks.
CAS of both eyes ≤ 2 points during the screening period and baseline;
According to the subject's medical history, CAS of both eyes ≤ 2 points at least 6 months before screening, or according to the subject's chief complaint or medical history, with all of the following characteristics: no progression of proptosis and no new diplopia caused by TED at least 6 months before screening or no progression of diplopia caused by TED and no new inflammatory TED symptoms;
According to the subject's chief complaint or medical history, the first TED diagnosis before screening was ≥ 2 years and < 10 years.
At baseline, the eyeball protrusion of the study eye decreased by ≥2 mm compared with the screening period;
Subjects who have been previously diagnosed with DON, or who are determined by the investigator to have DON during screening (defined as: orbital MRI/CT showing orbital apex crowding or optic nerve compression, and at least 2 of the following ophthalmological examination abnormalities that cannot be explained by other reasons: ① best corrected visual acuity [BCVA] < 0.8 or BCVA decreased by ≥ 2 lines compared with before the onset; ② abnormal pupillary light reflex or relative pupillary afferent disorder; ③ color vision abnormalities; ④ optic disc edema and optic disc pallor on fundus examination; ⑤ visual field loss; ⑥ visual evoked potential with prolonged latency and/or decreased amplitude);
Patients with corneal ulcers that are judged by the researchers to have no relief after treatment;
Planned to receive orbital radiotherapy or surgical treatment for TED (including orbital decompression, strabismus correction, eyelid correction, etc.) at any time before baseline or during the study period;