Trial to Evaluate the Safety and Tolerability of Repeated Intravitreal Injection of IBI302 in Neovascular AMD Patients

• Status: Completed
• Trial end date: 2021-05-08
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed for multi-center, open-label, randomized, dose escalation phase I trial to evaluate the safety and tolerability of a multiple dose intravitreal injection of IBI302 in neovascular AMD patients.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
• Treatments: Aflibercept; Immunoglobulin Fc Fragments

Criteria

Inclusion Criteria:

Inclusion criteria

1. Male or female patient ≥ 50 yrs. of age.

2. Active subfoveal or parafoveal CNV secondary to neovascular AMD.

3. Willing and able to sign informed consent form and comply with visit and study procedures per protocol.

Exclusion criteria

1. Presence of uncontrolled glaucoma in the study eye (defined as IOP≥30mmHg despite the standardized treatment);

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

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

4. 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;

5. Diabetic patients have any of the following conditions:HbA1c>7.5% when screening;