Mapping the methodological framework of diabetic retinopathy interventional trials: a scoping review on trial design, execution, and reporting practices.

Abstract

Diabetic Retinopathy (DR) is a prevalent and sight-threatening ocular complication of diabetes, and one of the leading causes of vision loss and blindness among the working-age population worldwide. Driven by a growing understanding of the pathophysiological mechanisms underlying DR, treatment strategies have evolved from a sole focus on glycemic control to comprehensive, multi-targeted, and multimodal therapies. This study systematically summarizes the characteristics of current clinical trials focused on DR treatment and evaluates the employed research methodologies. The aim of this review is to explore methodological trends in specific domains, with the hope that such insights may inform future efforts to optimize trial design and improve trial quality. This study followed the PRISMA-ScR reporting guidelines. Clinical trials registered on ClinicalTrials.gov and the Chinese Clinical Trial Registry (ChiCTR) were retrieved. In addition, clinical trials indexed in PubMed from July 23, 2016 to July 23, 2026 were retrieved. Data from the included studies were extracted and presented in tabular form. Clinical research targeting DR has expanded rapidly, reflecting a shift toward diverse interventions like anti-Vascular endothelial growth factor(anti-VEGF) drugs, laser treatments, and combined therapies. However, several methodological limitations were noted in the included studies, including the failure to specify diabetes type in over half of the cases, a predominance of small-sample trials, inconsistent reporting of intervention duration, and limited implementation of blinding due to practical constraints in ophthalmic interventions. This review represents the first comprehensive assessment of current DR clinical research, exposing key design weaknesses in existing trials. Future meta-analyses and systematic evaluations, informed by the methodological gaps identified in this review, are urgently needed to generate robust evidence that can guide optimal treatment strategies.