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

A Multi-center, Randomized, Double-masked, Active-controlled Study to Evaluate the Longer Interval of Intravitreal (IVT) Injection of IBI302 in Subjects With Neovascular Age-related Macular Degeneration (nAMD)

The study is designed for multi-center, randomized, double-masked, active-controlled study to evaluate the longer interval of intravitreal injection of IBI302 in subjects with neovascular age-related macular degeneration.

Inclusion Criteria:

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

Exclusion Criteria:

1. Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results.

2. 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;

3. Presence of uncontrolled glaucoma in the study eye(defined as IOP≥25mmHg, or judged by the investigators at the screening or baseline visit)

4. Presence of active intraocular or periocular inflammation or infection;

5. 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;

6. 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;

7. History of severe hypersensitivity/allergy to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine;

8. Pregnant or lactating women or women preparing to become pregnant or breastfeeding during the study period;

9. 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;

10. Other conditions unsuitable for enrollment judged by investigators