Clinical trial of HLX04- O administered by intravitreal injection vs. Ranibizumab in subjects with wet age-related macular degeneration.

THE PURPOSE OF THIS STUDY IS TO DETERMINE WHETHER THE STUDY MEDICATION, HLX04-O, IS EFFECTIVE IN TREATING WAMD COMPARED TO THE COMPARATOR DRUG, LUCENTIS®. IN THIS STUDY, IF BOTH EYES ARE DIAGNOSED WITH WAMD OR OTHER OCULAR DISEASES AND THE OTHER (NON-STUDY) EYE REQUIRES TREATMENT WITH INTRAVITREAL ANTI-VEGF INJECTIONS WITHIN 3 MONTHS AS ASSESSED BY THE INVESTIGATORS, PATIENTS WILL BE EXCLUDED FROM THE STUDY. IF THE PATIENT'S OTHER (NON-STUDY) EYE REQUIRES TREATMENT FOR WAMD DURING THE STUDY, AT THE INVESTIGATOR'S DISCRETION AND IF APPLICABLE AND ALLOWED BY LOCAL PRACTICE, THE OTHER EYE MAY BE TREATED WITH STANDARD TREATMENT (RANIBIZUMAB / AFLIBERCEPT/ CONBERCEPT, ETC.) ALL EFFICACY AND SAFETY ASSESSMENTS RELATED TO THE EYE(S) WILL BE PERFORMED IN BOTH EYES AT ALL STUDY VISITS, REGARDLESS OF WHETHER OR NOT THE OTHER EYE IS TREATED (SECTION 6). THIS STUDY WILL ALSO ASSESS TOLERABILITY (HOW YOUR BODY REACTS TO THE DRUG), PHARMACOKINETIC (PK) PARAMETERS (HOW THE BODY ABSORBS, DISTRIBUTES AND ELIMINATES HLX04-O) AND IMMUNOGENICITY (WHETHER HLX04-O CAUSES YOUR BODY TO PRODUCE PROTEINS, ALSO KNOWN AS ANTIBODIES, CAPABLE OF REDUCING THE EFFECT OF THE DRUG).