Regulatory Post-Marketing Surveillance Study for Brolucizumab

Incidence of adverse events and serious adverse events

Incidence of adverse events and serious adverse events

The ETDRS chart has been introduced as a standardized visual acuity (VA) testing chart. It uses 14 lines of 5 Sloan letter optotypes in each line in logarithmic progression. The space between lines and letters is proportionally equal keeping the effect of contour interaction constant. The threshold VA corresponds to the line in which 3 out of 5 optotypes were correctly identified. Alternatively, a by-letter scoring system (-0.02 logMAR credited for each letter correctly read) can be used. The testing distance can be varied; the corresponding visual acuity can be read easily from the chart. The chart is mounted on a box that is backlit by fluorescent tubes. For repeated measurements, the chart itself can be exchanged, providing different letters for different eyes.

CST is measured as one parameter by Optical coherence tomography.

BCVA is the best possible vision that an eye can achieve with the use of glasses or contact lenses. It is measured by ETDRS chart or equivalent with the use of glasses or contact lenses

BCVA is the best possible vision that an eye can achieve with the use of glasses or contact lenses. It is measured by ETDRS chart or equivalent with the use of glasses or contact lenses

CST is measured as one parameter by Optical coherence tomography.

Number of Brolucizumab injections to be collected

Loading phase: ≥ 3 injection during first 4 months

Percentage(%) of patients who maintained with 12 weeks interval

Proportion of patients with Intraretinal fluid (IRF), subretinal fluid (SRF) or sub-retinal pigment epithelium (sub-RPE) fluid defined as presence/absence

Number of injections of prior anti- vascular endothelial growth factor (VEGF) treatment

Agent of prior anti - vascular endothelial growth factor (VEGF) injections

Predictive factors of patients identified with persistent disease activity. Persistent disease activity is defined as presence of fluid and CST of at least 200µm

Number of participants that are treatment naïve / non-naïve to be collected

Number of participants by treatment interval to be collected

Number of participants with concomitant treatments to be collected

Post injection emperical treatment means any medication or therapy (usually topical medication such as topical antibiotics, topical steroid..etc.) routinely prescribed on the same day of injection in order to prevent post injection complications. It is differentiated from concomitant medication.