This study is an open-label, multicenter, single-arm, observational post-marketing surveillance.
The investigators will collect safety information and evaluate effectiveness in patients who are prescribed Beovu ® Injection, Beovu ®Prefilled Syringe (brolucizumab) in the approved indication after receiving informed consent over a period of 12 weeks. In addition, longer-term data (24 weeks, optionally 36 weeks) will be collected.
Study Type
OBSERVATIONAL
Enrollment
3,000
Prospective observational study. There is no treatment allocation. Patients administered brolucizumab, that have started before inclusion of the patient into the study will be enrolled.
Incidence of adverse events at 12 weeks
Incidence of adverse events and serious adverse events
Time frame: 12 weeks
Incidence of adverse events at 24 weeks and optionally at 36 weeks
Incidence of adverse events and serious adverse events
Time frame: Up to 36 weeks
Proportion of patients gaining or losing more than 15 letters on the ETDRS chart
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.
Time frame: Week 12, week 24, optionally week 36
Mean change of Central Subfield Thickness (CST) from baseline
CST is measured as one parameter by Optical coherence tomography.
Time frame: Baseline, week 12, week 24, optionally week 36
Mean change of Best Corrected Visual Acuity (BCVA) from baseline
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
Time frame: Baseline, week 12, week 24, optionally week 36
Novartis Pharmaceuticals
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Novartis Investigative Site
Daegu, Dalseo Gu, South Korea
RECRUITINGNovartis Investigative Site
Goyang-si, Gyeonggi-do, South Korea
RECRUITINGNovartis Investigative Site
Guri-si, Gyeonggi-do, South Korea
RECRUITINGNovartis Investigative Site
Suwon, Gyeonggi-do, South Korea
RECRUITINGNovartis Investigative Site
Iksan Si, Jeonlabuk Do, South Korea
RECRUITINGNovartis Investigative Site
Daejeon, Korea, South Korea
RECRUITINGNovartis Investigative Site
Busan, South Korea
RECRUITINGNovartis Investigative Site
Busan, South Korea
RECRUITINGNovartis Investigative Site
Busan, South Korea
RECRUITINGNovartis Investigative Site
Daegu, South Korea
RECRUITING...and 18 more locations
Mean Best Corrected Visual Acuity (BCVA)
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
Time frame: Baseline, week 12, week 24, optionally week 36
Mean Central Subfield Thickness (CST)
CST is measured as one parameter by Optical coherence tomography.
Time frame: Baseline, Week 12, week 24, optionally week 36
Number of injections
Number of Brolucizumab injections to be collected
Time frame: Up to 36 weeks
Percentage of patients completing the loading phase
Loading phase: ≥ 3 injection during first 4 months
Time frame: 4 months
Percentage of patients who maintained with 12 weeks interval
Percentage(%) of patients who maintained with 12 weeks interval
Time frame: Up to 36 weeks
Proportion of patients with retinal fluid
Proportion of patients with Intraretinal fluid (IRF), subretinal fluid (SRF) or sub-retinal pigment epithelium (sub-RPE) fluid defined as presence/absence
Time frame: Week 12, week 24, optionally week 36
Prior anti-VEGF treatment history - number of prior injections
Number of injections of prior anti- vascular endothelial growth factor (VEGF) treatment
Time frame: Baseline
Prior anti-VEGF treatment history - agent of prior injections
Agent of prior anti - vascular endothelial growth factor (VEGF) injections
Time frame: Baseline
Predictive factors of treatment outcomes (persistent disease activity)
Predictive factors of patients identified with persistent disease activity. Persistent disease activity is defined as presence of fluid and CST of at least 200µm
Time frame: Week 24
Treatment naïve/non-naïve
Number of participants that are treatment naïve / non-naïve to be collected
Time frame: Baseline
Treatment interval
Number of participants by treatment interval to be collected
Time frame: Up to week 36
Concomitant treatments
Number of participants with concomitant treatments to be collected
Time frame: Baseline
Number of participants with post injection empirical treatment
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.
Time frame: Week 12, week 24, optionally week 36