A Study of Longer Interval of IVT IBI302 in Subjects With nAMD

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(Vascular Endothelial Growth Factor) therapy or anti-complement therapy within 3 months prior to screening;
  • Laser photocoagulation within 3 months prior to screening;
  • Photodynamic therapy or vitreoretinal surgery;
  • Intraocular glucocorticoid injection within 6 months prior to enrollment;
• Presence of any systemic disease: including but not limited tractive infections (such as active viral hepatitis); unstable angina; cerebrovascular accident or transient cerebral ischemia (within 6 months prior to selection); myocardial infarction (within 6 months prior to selection); serious arrhythmia requiring medical treatment; liver, kidney or metabolic diseases; or malignant tumor;
• Participated in any clinical study of any other drug within three months prior to enrollment, or attempted to participate in other drug trials during the study;

Más betegség

• Subretinal hemorrhage>50% total lesion area and/or involvement in the macular foveal, fibrosis or atrophy area>50% total lesion area and/or involved of macular fovea;
• Presence of active intraocular or periocular inflammation or infection;
• History of severe hypersensitivity/allergy to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine;
• Other conditions unsuitable for enrollment judged by investigators

Egyéb

• Presence of uncontrolled glaucoma in the study eye(defined as IOP≥25mmHg, or judged by the investigators at the screening or baseline visit)
• Pregnant or lactating women or women preparing to become pregnant or breastfeeding during the study period;

• Willing and able to sign informed consent from and comply with visit and study procedures per protocol.
• Male or female patients≥50 yrs. of age.
• Active subfoveal or parafoveal CNV secondary to neovascular AMD on FFA or OCT.
• The CNV area≥50% lesion area on FFA in the study eye at screening visit.
• BCVA score of 24-78 letters using ETDRS charts in the study eye at the baseline.