Table 2.

Definitions of retinopathy events from each CVOT

	LEADER (2016) N = 9,340 (9)	SUSTAIN-6 (2016) N = 3,297 (8)	EXSCEL (2017) N = 14,752 (7,30)	HARMONY (2018) N = 9,463 (11)	REWIND (2019) N = 9,901 (10)	PIONEER-6 (2019) N = 3,183 (12)
Retinopathy exclusion criterion	None	None	None	None	None	Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 90 days before screening or within the period between screening and randomization
Method of ascertainment	Adverse event reporting at each study visit	Adverse event reporting at each visit + fundoscopy/fundus photography at scheduled visits (weeks 0, 56, 104 and 143)	Adverse event reporting at each study visit	Adverse event reporting at each study visit	Adverse event reporting at each study visit	Adverse event reporting at each visit + fundoscopy at scheduled visits (weeks −3, 50, and 83)
Retinopathy end point definition	The need for retinal photocoagulation or vitreous hemorrhage or diabetes-related blindness (defined as Snellen visual acuity of ≤20/200 [6/60], or visual field of <20°, in the better eye with best correction possible)	The need for retinal photocoagulation, or treatment with intravitreal agents, or vitreous hemorrhage, or diabetes-related blindness (defined as Snellen visual acuity of ≤20/200 [6/60], or visual field of <20°, in the better eye with best correction possible)	Diabetic eye disease: photocoagulation, cataract extraction, blindness, enucleation, steroid/Avastin injection, scleral buckling or retinal fixation procedure	Laser photocoagulation or antivascular endothelial growth factor treatment or vitrectomy for diabetic retinopathy/eye disease	Photocoagulation, antivascular endothelial growth factor therapy, or vitrectomy	Retinopathy and related complication events were identified through a search of terms in the Medical Dictionary for Regulatory Activities, version 20.1
Retinopathy adjudication (yes/no)	Yes	Yes	No	No	No	No