Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy

Incidences of non-ocular AEs and any Adverse Events of Special Interest

Time frame: 5 years, inclusive to the parent study

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

Time frame: 5 years, inclusive of the parent study

Proportion of participants achieving 0-step (no change), a ≥1-step, a ≥2-step, or a ≥3-step or greater change in DR per ETDRS-DRSS on digital stereoscopic fundus photography from baseline (ie, prior to ABBV-RGX-314 administration in the parent study)

Time frame: 5 years, inclusive to the parent study

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

Time frame: 5 years, inclusive to the parent study

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

Time frame: 5 years, inclusive to the parent study

Mean change from baseline (ie, prior to ABBV-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

Mean number of anti-VEGF injections through years 2, 3, 4, and 5 based on ongoing chart review in the study eye (DL4 participants only)

Time frame: 5 years, inclusive to the parent study

Mean number of anti-VEGF injections in years 2, 3, 4, and 5 based on ongoing chart review in the study eye (DL4 participants only)

Time frame: 5 years, inclusive to the parent study

Mean anti-VEGF injection annualized rate through years 2, 3, 4, and 5 based on ongoing chart review in the study eye (DL4 participants only)

Time frame: 5 years, inclusive to the parent study

Mean anti-VEGF injection annualized rate in years 2, 3, 4, and 5 based on ongoing chart review in the study eye (DL4 participants only)

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

Mean number of retina specialist visits attended for complications of DR based on chart review

Time frame: 5 years, inclusive to the parent study