This study focuses on Diabetic Macular Edema, a condition where swelling occurs in the central part of the retina, which is the light-sensitive tissue at the back of the eye. This swelling is caused by leaking blood vessels and can lead to vision problems. The purpose of the study is to compare the effectiveness and safety of a new medication, AVT29, against a high dose of Eylea. Both medications contain the active substance aflibercept and are administered via intravitreal use, which means the medicine is injected directly into the eye.
During the study, participants will receive either AVT29 or a high dose of Eylea. The medical team will monitor changes in best-corrected visual acuity, which refers to the clearest vision possible with glasses or contact lenses. Additionally, the study will look at changes in central subfield thickness, a measurement of how much the middle part of the retina has thickened due to swelling, and the presence of intraretinal fluid, which is liquid trapped inside the layers of the retina. Regular check-ups will also be performed to monitor intraocular pressure, the fluid pressure inside the eye, and other general health factors to ensure safety throughout the process.



Bulgaria
Czechia
Hungary
Latvia
Poland
Slovakia