Retinal Ischemia Characterization in Diabetes - "RICHARD"

Prior treatment

• Any eye surgery, including laser, and anti-VEGF within a period of 6-months.

Other illness

• Cataract or other eye disease that may interfere with fundus examinations or OCT/OCTA signal strength.

Lab values

• HbA1c \> 12% in the last measurement prior to the study visit (V0). Study Eye: Only one eye per subject will be considered for the primary statistical analysis (Study Eye). If both eyes meet the inclusion criteria the study eye will be the one that has a higher level of DR (ETDRS classification). If both eyes have the same ETDRS DRSS grading, the eye with higher BCVA will be chosen. If both eyes have the same BCVA, the right eye will be chosen.

Age

• Age-related macular degeneration, glaucoma, vitreomacular disease, other retinal vascular disease, or any ocular condition that, in the opinion of the investigator may affect retinopathy status or alter VA during the study.

Other

• Presence of diabetic macular edema (DME) involving the center of the macula in the study eye and needing immediate treatment.
• Presence of CI-DME defined as central subfield thickness on OCT ≥305 µm if male or ≥290 µm if female on Zeiss Cirrus OCT \[12\] with vision loss and needing immediate treatment.
• Dilatation of the pupil \> 5 mm.

• Diabetes type 2 according to 1985 WHO definition.
• Age over 18 years old.
• NPDR levels ETDRS DRSS (43 with IRMA, 47 or 53), based on the ETDRS criteria - 7 fields CFP and UWF FFA for 43 with IRMA after confirmation by the Reading Centre (CORC).
• Refraction with a spherical equivalent less than 5 diopters
• Able to provide informed consent.