RGX-314 Gene Therapy Administered in the Suprachoroidal Space for Participants With Diabetic Retinopathy (DR) With and Without Center Involved-Diabetic Macular Edema (CI-DME)

Prior treatment

• Patients who had a prior vitrectomy surgery.
• Patients who had a prior vitrectomy surgery.

Other illness

• Active or history of retinal detachment in the study eye.
• Any evidence or documented history of PRP or retinal laser in the study eye.
• Active or history of retinal detachment in the study eye.
• Any evidence or documented history of PRP or retinal laser in the study eye.

Other

• Neovascularization in the study eye from a cause other than DR.
• Presence of any active CI-DME.
• Women of childbearing potential.
  • Part 2 (DR with CI-DME):
• Neovascularization in the study eye from a cause other than DR.
• Women of childbearing potential.
  • Note: Other inclusions/exclusions criteria apply.

• Patients 25-89 years of age with a diabetic retinopathy (DR) diagnosis of nonproliferative diabetic retinopathy (NPDR) and proliferative diabetic retinopathy (PDR) secondary to diabetes mellitus Type 1 or 2 for which PRP or anti-VEGF injections can be safely deferred for at least 6 months
• HbA1c \< 12%.
• Best corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better).
• Prior history of CI-DME in the study eye is acceptable.
• Must be willing and able to provide written, signed informed consent.
• Patients 25-89 years of age with diabetic retinopathy secondary to diabetes mellitus Type 1 or 2.
• HbA1c \< 12%
• Macular thickening secondary to DME involving the center of the fovea, CST on SD-OCT (≥ 325 μm)
• Best corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye of 78-25 letters (approximate Snellen equivalent of 20/32 to 20/320)
• Participants must have demonstrated a meaningful response to anti-VEGF therapy.
• Must be willing and able to provide written, signed informed consent

Criteria the registry did not label

• Part 1 (DR without CI-DME):