Neovascular Age-related Macular Degeneration
Conditions
Keywords
nAMD, Neovascularized age related macular degeneration, Beovu, regulatory Post Marketing Study, Beovu Injection, Beovu Prefilled Syringe
Brief summary
This study is an open-label, multicenter, single-arm, observational post-marketing surveillance.
Detailed description
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.
Interventions
OTHERbrolucizumab
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.
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Patients aged ≥18 years with nAMD that are prescribed with Brolucizumab as per approved local product information 2. Patients who consent to participate in the study after the purpose and nature of the study have clearly explained to them (written informed consent)
Exclusion criteria
1. 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. 2. Patients participating in other investigational drug trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events at 12 weeks | 12 weeks | Incidence of adverse events and serious adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients gaining or losing more than 15 letters on the ETDRS chart | Week 12, week 24, optionally week 36 | 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. |
| Mean change of Central Subfield Thickness (CST) from baseline | Baseline, week 12, week 24, optionally week 36 | CST is measured as one parameter by Optical coherence tomography. |
| Mean change of Best Corrected Visual Acuity (BCVA) from baseline | Baseline, week 12, week 24, optionally week 36 | 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 |
| Mean Best Corrected Visual Acuity (BCVA) | Baseline, week 12, week 24, optionally week 36 | 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 |
| Mean Central Subfield Thickness (CST) | Baseline, Week 12, week 24, optionally week 36 | CST is measured as one parameter by Optical coherence tomography. |
| Number of injections | Up to 36 weeks | Number of Brolucizumab injections to be collected |
| Percentage of patients completing the loading phase | 4 months | Loading phase: ≥ 3 injection during first 4 months |
| Percentage of patients who maintained with 12 weeks interval | Up to 36 weeks | Percentage(%) of patients who maintained with 12 weeks interval |
| Incidence of adverse events at 24 weeks and optionally at 36 weeks | Up to 36 weeks | Incidence of adverse events and serious adverse events |
| Prior anti-VEGF treatment history - number of prior injections | Baseline | Number of injections of prior anti- vascular endothelial growth factor (VEGF) treatment |
| Prior anti-VEGF treatment history - agent of prior injections | Baseline | Agent of prior anti - vascular endothelial growth factor (VEGF) injections |
| Predictive factors of treatment outcomes (persistent disease activity) | Week 24 | Predictive factors of patients identified with persistent disease activity. Persistent disease activity is defined as presence of fluid and CST of at least 200µm |
| Treatment naïve/non-naïve | Baseline | Number of participants that are treatment naïve / non-naïve to be collected |
| Treatment interval | Up to week 36 | Number of participants by treatment interval to be collected |
| Concomitant treatments | Baseline | Number of participants with concomitant treatments to be collected |
| Number of participants with post injection empirical treatment | Week 12, week 24, optionally week 36 | 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. |
| Proportion of patients with retinal fluid | Week 12, week 24, optionally week 36 | Proportion of patients with Intraretinal fluid (IRF), subretinal fluid (SRF) or sub-retinal pigment epithelium (sub-RPE) fluid defined as presence/absence |
Countries
South Korea
Contacts
Primary ContactNovartis Pharmaceuticals
Backup ContactNovartis Pharmaceuticals
Outcome results
None listed