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

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
• Treatments: Aflibercept

Criteria

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 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