Compare the Efficacy and Safety of HLX04-O With Ranibizumab in Subjects With wAMD

• Status: Not yet recruiting
• Trial end date: 2024-03-31
• Target enrollment: 0
• Participant gender: All

Summary

this study will compare the efficacy and safety of HLX04-O administered by IVT with ranibizumab in patients with active CNV secondary to AMD.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Henlius Biotech
• Treatments: Antibodies; Antibodies, Monoclonal; Endothelial Growth Factors; Mitogens; Ranibizumab

Criteria

Inclusion Criteria:

1. Capable to fully understand and sign the informed consent form (ICF).

2. Women or men aged ≥50 years when signing the ICF.

3. Study eye is diagnosed with neovascular age related macular degeneration and would need an intravitreal injection.

Exclusion Criteria:

1. Vitreous hemorrhage in study eye within 3 months prior to dose 1.

2. Uncontrolled glaucoma

3. Equivalent spherical diopter of the study eye ≥-8D.

4. Previous extraocular or periocular surgery within 1 month prior to dose 1, or current unhealed wound, moderate or severe ulcer or history of fracture in the study eye.

5. Participated in any drug (other than vitamins and minerals) or device clinical trials within 3 months or the duration of 5 half-lives of the study drug (which is longer) prior to dose 1 and have used the test drug or received device treatment.

6. Pregnancy or lactation.

7. Men or women fail to meet both of the following ones: 1) women must have a negative serum pregnancy test result within 14 days prior to initiation of the study intervention; 2) agreement to remain abstinent (refrain from heterosexual intercourse) or use effective contraceptive methods from signed ICF to at least 6 months following the last dose of the study intervention. Effective contraceptive methods include bilateral tubal ligation, male sterilization, established physical contraception and copper intrauterine devices (IUDs).

8. Stroke or myocardial infarction within 6 months prior to dose 1, uncontrolled hypertension, etc.

9. Evidence of significant uncontrolled concomitant diseases such as cardiovascular diseases, nervous system diseases, respiratory system diseases, urinary system diseases, digestive system diseases and endocrine diseases.

10. Current treatment for active systemic infection, or history of recurrent serious infections.

11. Known active or suspected autoimmune diseases, requiring systemic immunosuppressive therapy.

12. Known allergy to any component of the study intervention or history of allergy to fluorescein or indocyanine green, any anesthetics or antimicrobial agents used during the course of the study.

13. In the Investigator's judgment, there is evidence of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or render the participant at high risk for treatment complications, or other conditions considered not amenable to this study.

Other protocol defined inclusion and exclusion criteria may apply.