Phase III Study Comparing BAT5906 and Lucentis Injections for Treating Diabetic Macular Edema in Adults Aged 18 to 80

What this Trial Is About

Researchers are evaluating the efficacy and safety of BAT5906 compared to Lucentis in people with diabetic macular edema DME. This multicenter, randomized, double-blind trial plans to enroll 406 participants aged 18 to 80 years who have DME affecting the central part of the retina. The primary goal is to assess changes in best-corrected visual acuity BCVA from the start of the study to week 52 using the ETDRS chart. Participants are randomly assigned to receive either BAT5906 or Lucentis through intravitreal injections directly into the eye. Each treatment is given once every 4 weeks for three doses, followed by monitoring visits every 4 weeks with possible additional doses as needed, continuing through week 52. BAT5906 is administered at 4.0 mg per eye, while Lucentis is given at 0.5 mg per eye. Throughout the study, participants undergo regular eye exams, safety assessments, and blood tests to monitor immune response. Researchers measure visual acuity changes to determine treatment effects. The study includes ongoing safety monitoring and assessments until week 52 to evaluate both treatments effectiveness and safety in managing DME.

Efficacy Evaluation Study of BAT5906 and Lucentis® in Patients With Diabetic Macular Edema