INITIATE Study

INITIATE Study

A multi-country, post marketing observational study of DME patients with suboptimal response to anti-VEGF who are initiated with dexamethasone intravitreal implant (DEX-I).

Principal Investigator: Dr. Giuseppe Fasolino


Diabetic macular edema (DME) is a retinal swelling that occurs in patients with diabetes due to the leakage of fluid from blood vessels into the macula. The macula is the part of the retina that allows you to see clearly. When the macula swells with fluid, the center of the visual field becomes blurred and this is often treated with injections of anti-vascular endothelial growth factor (anti-VEGF), a protein that is naturally present in the human body and contributes to the development of new blood vessels. 

Aim of the study

This real-world study has been organized to collect information on patients treated with Ozurdex® who show a sub-optimal response to anti-VEGF in a routine clinical setting.
 
AbbVie (the study sponsor) is interested in describing the treatment patterns and patient’s characteristics before Ozurdex® initiation and in evaluating the impact of time of Ozurdex® initiation on clinical outcomes. 


https://clinicaltrials.gov/study/NCT05978622