A Dose Escalation Study of IBI333 in Subjects With Neovascular Age-related Macular Degeneration

Korábbi kezelés

• Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results;
• Prior any treatment of following in the study eye:
  • Anti-VEGF therapy within 90 days prior to screening;
  • Intraocular glucocorticoid injection within 180 days prior to screening;
  • Laser photocoagulation or photodynamic therapy within 90 days prior to screening;
  • Intraocular surgery within 90 days prior to screening;
  • Laser posterior capsulotomy, laser trabeculectomy or laser peripheral iridectomy within 30 days prior to screening;
• Systemic administration of steroids within 30 days prior to screening;
• Systemic administration of anti-VEGF drugs within 90 days prior to screening;
• Participated in any clinical study of any other drug within 90 days prior to enrollment, or attempted to participate in other drug trials during the study;

Más betegség

• Active ocular or periocular inflammation/infection in either eye;
• Uncontrolled hypertension (defined as systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg);
• History of severe hypersensitivity/allergic to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine;
• Other conditions unsuitable for enrollment judged by investigators.

Laborértékek

• Glycated hemoglobin (HbA1c) > 8% within 28 days prior to screening;

Egyéb

• Tractional retinal detachment, pre-retinal fibrosis, vitreomacular traction, or epiretinal membrane involving the fovea or disrupting the macular structure in the study eye;

• Willing and able to sign informed consent form and comply with visit and study procedures per protocol.
• Male or female patients ≥ 50 yrs. of age.
• Active CNV lesions secondary to neovascular AMD.
• BCVA score of 19-78 letters using ETDRS charts in the study eye.
• Female subjects of childbearing age or male subjects with childbearing age female partner agree to take effective contraceptive measures from the screening period to 6 months after the end of treatment.