Regulatory Post-Marketing Surveillance Study for Brolucizumab
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorNovartis Pharmaceuticals
About this trial
This study is an open-label, multicenter, single-arm, observational post-marketing surveillance.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged ≥18 years with nAMD that are prescribed with Brolucizumab as per approved local product information
Patients who consent to participate in the study after the purpose and nature of the study have clearly explained to them (written informed consent)
Disqualifiers
Contraindications as per local prescribing information 1) Hypersensitivity to the active substance or to any of the excipients. 2) Active or suspected ocular or periocular infection. 3) Active intraocular inflammation.
Patients participating in other investigational drug trial
Trial population
Patients aged ≥18 years who present to the participating study sites, where the decision to newly prescribe Beovu ® Injection, Beovu ®Prefilled Syringe (brolucizumab) were made prior to evaluating eligibility for this study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
brolucizumab
Other interventionProspective observational study. There is no treatment allocation. Patients administered brolucizumab, that have started before inclusion of the patient into the study will be enrolled.
Treatment groups
3,000 Participants
are divided into 1 treatment groupGroup A: Brolucizumab1 intervention
Trial outcomes
Primary outcomes
1
Incidence of adverse events at 12 weeks
Incidence of adverse events and serious adverse events
Time frame
12 weeksSecondary outcomes
1
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 weeks2
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 363
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 364
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 36Sponsors and contacts
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Source ClinicalTrials.gov