FARICIMAB for Diabetic macular edema|Macular edema

Inclusion criteria

• {"criterion_text":"- signed informed consent"}
• {"criterion_text":"- age ≥18 years, both sexes"}
• {"criterion_text":"- HbA1c of ≤16%"}
• {"criterion_text":"- best-corrected visual acuity (BCVA) in the study eye above >25 letters of Early Treatment Diabetic Retinopathy Study (ETDRS) nomenclature (corresponding to 1.2 VAlogMAR)"}

Exclusion criteria

• {"criterion_text":"- Pregnancy or breastfeeding"}
• {"criterion_text":"- participation in any non-interventional or interventional study"}
• {"criterion_text":"- previously treated with Faricimab, photodynamic therapy and/or macular laser therapy (photocoagulation)"}
• {"criterion_text":"- visual acuity below 0.2 VA decimal (equivalent to 0.70 logMAR)"}
• {"criterion_text":"- glaucoma, intermediate and late age-related macular degeneration, uveitis"}
• {"criterion_text":"- hypertensive retinopathy stage 3 and 4"}

Primary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Change in BCVA measured as letters on the ETDRS chart at a starting distance of 4 m, collected for each participant at baseline and at 12 months."}

Secondary endpoints

• {"endpoint_text":"- Number of injections during the 12 months therapy on a Q4W, Q8W, Q12W, or Q16W treatment interval at 12 months","definition_or_measurement_approach":"Count of intravitreal injections received by each participant over 12 months, categorized by treatment interval (Q4W, Q8W, Q12W, Q16W)."}
• {"endpoint_text":"- 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: ●\tChange from baseline to at 12 months ●\tabsence of DME (CST <325 μm) to at 12 months ●\tabsence of IRF (intra-retinal fluid) to at 12 months ●\tabsence of SRF (sub-retinal fluid) to at 12 months ●\tabsence of IRF and SRF to at 12 months","definition_or_measurement_approach":"Anatomical outcomes assessed by SD-OCT: change from baseline to 12 months; central subfield thickness (CST) <325 μm indicating absence of DME; presence/absence of intra-retinal fluid (IRF) and sub-retinal fluid (SRF) at 12 months."}
• {"endpoint_text":"- ●\tChange from baseline in BCVA over time ●\tgaining ≥10, ≥5, or ≥0 ETDRS letters in BCVA from at baseline to at 12 month ●\tavoiding a loss of ≥15, ≥10, or ≥5 ETDRS letters in BCVA from at baseline to at 12 month ●\tgaining ≥15 ETDRS letters from at baseline or achieving BCVA of ≥84 ETDRS letters to at 12 month","definition_or_measurement_approach":"BCVA change metrics over time and responder/decliner thresholds based on ETDRS letters from baseline to 12 months."}
• {"endpoint_text":"- ●\tBCVA Snellen equivalent of 20/40 (BCVA ≥69 ETDRS letters) or better to at 12 months ●\tBCVA Snellen equivalent of 20/200 (BCVA ≤38 ETDRS letters) or worse to at 12 months ●\tImproved vision measured by Adaptive Sensory Technology (AST) for contrast sensitivity and visual acuity","definition_or_measurement_approach":"Proportion achieving specified BCVA Snellen/ETDRS thresholds at 12 months; visual function measured by Adaptive Sensory Technology (contrast sensitivity and visual acuity)."}
• {"endpoint_text":"- ●\tlongitudinal WLR measurements from at baseline (first visit) to at 12 months) ●\tgaining WLR >0.1 or >0.5 or <0.1 from at baseline to at 12 month ●\tMean WLR at baseline in group 1a significant different from mean WLR at 12 months ●\tMean WLR at baseline in group 1b significant different from mean WLR at 12 months","definition_or_measurement_approach":"Longitudinal Wall-to-Lumen Ratio (WLR) measurements from baseline to 12 months; analyses of absolute changes and group-level comparisons for groups 1a and 1b."}
• {"endpoint_text":"- ●\tChange from baseline in FAZ (in µm2) to at 12 months ●\t>10% reduction of the FAZ to at 12 month","definition_or_measurement_approach":"Foveal avascular zone (FAZ) area change measured in µm2 from baseline to 12 months; proportion with >10% FAZ reduction at 12 months."}
• {"endpoint_text":"- Quantification of countable area size in mm2 and photoreceptor density (cones per mm2) by AO at an edema border. ●\tChange of area size mm2 (focused countable cones per mm2 in a defined retinal area) from baseline to at 12 month ●\tChange from baseline of photoreceptor density (cones per mm2) to at 12 month","definition_or_measurement_approach":"Adaptive optics (AO) measurements of countable retinal area (mm2) and photoreceptor (cone) density per mm2 at edema border; changes from baseline to 12 months."}

Germany

Latest Decision Or Authorization Date

26-02-2026

Number Of Sites

1

Number Of Participants

133

Primary sponsor

Full Name

Martin-Luther-Universitaet Halle-Wittenberg

Organisation Type

Educational Institution

Country Of Registered Address

Germany

Third parties

• {"country":"","full_name":"Roche Pharma AG","duties_or_roles":"Source of monetary support (listed under sourceOfMonetarySupport)","organisation_type":""}