A Multicenter, Randomized, Double-Blind Phase III Clinical Study Comparing the Efficacy and Safety of BAT5906 Versus Ranibizumab (Lucentis®) in Patients With Diabetic Macular Edema (DME)
A multicenter, randomized, double-blind, parallel-group, active-controlled non-inferiority trial. A total of 406 subjects with diabetic macular edema (DME) were planned for enrollment. After screening, eligible subjects were randomized in a 1:1 ratio to the treatment group or the control group. The treatment group received BAT5906 injection, while the control group received Lucentis®. During the trial, ophthalmic examinations and safety assessments were conducted according to the protocol for efficacy and safety evaluation. Blood samples were collected for immunogenicity assessment. The primary endpoint was the mean change in best-corrected visual acuity (BCVA) in the study eye from baseline to week 52 (measured using the ETDRS chart).
• All of the following criteria must be met for inclusion:
‣ Voluntarily signed informed consent form, willing and able to comply with outpatient visits and study procedures as scheduled by the trial.
⁃ Diagnosed with type 1 or type 2 diabetes, aged 18 to 80 years (including boundary values).
⁃ Diabetic macular edema (DME) with OCT findings demonstrating involvement of the macular center (fovea or paracentral fovea) in the study eye. (fovea or parafovea);
⁃ Central retinal thickness (CRT) of the study eye \>300 μm (or \>320 μm for Heidelberg OCT) as assessed by central image review during screening;
⁃ Best-corrected visual acuity (BCVA) of the study eye between 73 and 21 letters (using ETDRS chart, including boundary values; equivalent to Snellen visual acuity scores of 20/40 to 20/400);
⁃ Contralateral eye BCVA \> 24 letters (using ETDRS chart, equivalent to Snellen acuity 20/320); Note: If both eyes meet inclusion criteria, the eye with poorer BCVA is selected as the study eye, unless the investigator determines the other eye is more suitable.