Automated quantification of macular edema in patients with diabetic macular edema and their response to anti-VEGF: A study protocol

Abstract

Diabetes mellitus type 2 (T2DM) is the fastest-growing chronic condition. Diabetes mellitus can lead to a variety of complications, all of which have a significant impact on medical care expenditures as well as patient life span and wellbeing. The most prevalent microvascular ocular sequel of diabetes is diabetic retinopathy (DR), causing diffuse retinal edema from extensive capillary leakage and localized edema from microaneurysm leakage. A dilated capillary segment is also seen. It has been observed that the fluid first accumulates between the inner nuclear layers and the outer plexiform layer. Later, it may infiltrate the inner plexiform and nerve fiber layers, causing edema and affecting the retina’s total thickness. The fovea takes on a cystoid appearance on optical coherence tomography due to central fluid accumulation, and cystoid macular edema can be seen. Anti-vascular endothelial growth factor (anti-VEGF) medication is a cornerstone of DME treatment. Research has shown that drugs that attach to soluble VEGF can repair the blood-retinal barrier, alleviate macular edema, and enhance vision for the majority of DME patients. Ranibizumab is the only FDA-approved drug for DME, but bevacizumab is often used off-label and an FDA request for aflibercept is still pending. Regular injections are necessary for effective treatment, but new findings suggest that this requirement lessens after a year. The study aims to evaluate the impact of intravitreal Anti-VEGF injection by measuring the alterations in macular edema and relating it to the visual results. CTRI reference Number – REF/2023/07/071019