Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With Diabetic Retinopathy

Mean change from baseline (ie, prior to RGX-314 administration in the parent study) in DR by ETDRS-DRSS on 4-widefield digital stereoscopic fundus photography

Time frame: 5 years, inclusive of the parent study

Proportion of participants achieving 0-step (no change), a 1-step or greater, a 2-step or greater, or a 3-step or greater improvement in DR per ETDRS-DRSS on 4-widefield digital stereoscopic fundus photography from baseline

Time frame: 5 years, inclusive to the parent study

Mean change from baseline (ie, prior to RGX-314 administration in the parent study) in BCVA

Time frame: 5 years, inclusive to the parent study

Proportion of participants gaining or losing ≥5, 10 and 15 letters in BCVA compared with baseline (ie, prior to RGX-314 administration in the parent study)

Time frame: 5 years, inclusive to the parent study

Mean change from baseline (ie, prior to RGX-314 administration in the parent study) in central subfield thickness as measured by SD-OCT

Time frame: 5 years, inclusive to the parent study

Mean change from baseline (ie, prior to RGX-314 administration in the parent study) in the area of retinal nonperfusion on ultra-widefield Optos FA

Time frame: 5 years, inclusive to the parent study

Proportion of participants requiring any additional intervention for ocular diabetic complications (eg, anti-VEGF intravitreal injection or PRP)

Time frame: 5 years, inclusive to the parent study

Proportion of participants with any sight-threatening ocular diabetic complications

Time frame: 5 years, inclusive to the parent study