Study design
This prospective phase 2/3 triple-blind, uni-center parallel-group randomized controlled pilot trial was conducted to investigate the efficacy of a combination of SCTA and IVB administered in patients with DME. The study designed as per the Declaration of Helsinki was approved by the Ethics Committee of Isfahan University of Medical Sciences, Isfahan, Iran (IR.MUI.MED.REC.1398.410). All the participants were briefed on the benefits/risks of the study, asked to sign informed consent forms and then included in the study. The trial was registered in Iranian Registry of Clinical Trials (IRCT20200314046761N1, first registration date: 21/03/2020).