A phase IV study of Faricimab to explore associations of visual acuity benefits and changes in vascular integrity using adaptive optics in patients with diabetic macular edema

Macular edema

Improvement of visual acuity, measured by change in BCVA (metric variable). BCVA (as measured as letters on the ETDRS chart at a starting distance of 4 m) will be collected from each individual patients of group 1a and group 1b at baseline and at 12 months

Number of injections during the 12 months therapy on a Q4W, Q8W, Q12W, or Q16W treatment interval at 12 months, To evaluate the efficacy of Faricimab on anatomical outcomes using SD-OCT as a clinically relevant parameter for the decision of the treat and extend scheme (T&E). Corresponding secondary endpoints: ● Change from baseline to at 12 months ● absence of DME (CST <325 μm) to at 12 months ● absence of IRF (intra-retinal fluid) to at 12 months ● absence of SRF (sub-retinal fluid) to at 12 months ● absence of IRF and SRF to at 12 months, ● Change from baseline in BCVA over time ● gaining ≥10, ≥5, or ≥0 ETDRS letters in BCVA from at baseline to at 12 month ● avoiding a loss of ≥15, ≥10, or ≥5 ETDRS letters in BCVA from at baseline to at 12 month ● gaining ≥15 ETDRS letters from at baseline or achieving BCVA of ≥84 ETDRS letters to at 12 month, ● BCVA Snellen equivalent of 20/40 (BCVA ≥69 ETDRS letters) or better to at 12 months ● BCVA Snellen equivalent of 20/200 (BCVA ≤38 ETDRS letters) or worse to at 12 months ● Improved vision measured by Adaptive Sensory Technology (AST) for contrast sensitivity and visual acuity, ● longitudinal WLR measurements from at baseline (first visit) to at 12 months) ● gaining WLR >0.1 or >0.5 or <0.1 from at baseline to at 12 month ● Mean WLR at baseline in group 1a significant different from mean WLR at 12 months ● Mean WLR at baseline in group 1b significant different from mean WLR at 12 months, ● Change from baseline in FAZ (in µm2) to at 12 months ● >10% reduction of the FAZ to at 12 month, Quantification of countable area size in mm2 and photoreceptor density (cones per mm2) by AO at an edema border. ● Change of area size mm2 (focused countable cones per mm2 in a defined retinal area) from baseline to at 12 month ● Change from baseline of photoreceptor density (cones per mm2) to at 12 month

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Germany