SYF3b56d3da47a14f6fb20bdd25f7b0a473Registry ID: 2023-509829-52-00|RecruitingPhase 4
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interventional
N/A
1 country
1
To investigate BCVA improvement by Faricimab treatment from baseline and after 12 months of therapy (primary endpoint visits at baseline and week 52 as measured as letters on the ETDRS chart at a starting distance of 4 m) in a patient population with diabetic macular edema
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 28, 2025
Actual (reported)The primary endpoint is the change in Best Corrected Visual Acuity (BCVA) from baseline to the at month 12 visit (Week 52). BCVA is measured using the ETDRS chart at a starting distance of 4 m.
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, ≥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 ● Proportion of patients with improved vision measured as an increased change of recognized letters by Adaptive Sensory Technology (AST) for contrast sensitivity and visual acuity
● change of wall to lumen ratio WLR from at baseline (first visit) to at 12 months) ● proportion of patients gaining WLR >0.1 or >0.5 or <0.1 from at baseline to at 12 month
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Vabysmo 120 mg/mL solution for injection
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Vabysmo 120 mg/mL solution for injection
Named ingredient: faricimab
View registry recordMartin-Luther-Universitaet Halle-Wittenberg
Halle (Saale), 06120, Germany
Prof. Arne Viestenz
First Submitted
March 28, 2025
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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