Neovascular Age-related Macular DegenerationNCT04985487
Regulatory Post-Marketing Surveillance Study for Brolucizumab
An observational study of Neovascular Age-related Macular Degeneration, run by Novartis Pharmaceuticals at 45 sites in South Korea.
Trial summary
This study is an open-label, multicenter, single-arm, observational post-marketing surveillance. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Neovascular Age-related Macular Degeneration
- What is being tested?
- brolucizumab
- How many people
- 3,369 participants
- Where
- 45 sitesSouth Korea
- Study dates
- 18 Aug 2021to 14 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
45 sites in 1 country.
45 sites in 1 country
South Korea45 sites
Novartis Investigative Site
Anyang-si, Gyeonggi-do, 14068
Novartis Investigative Site
Busan, Busan, 48064
Novartis Investigative Site
Busan, South Korea, 47524
Novartis Investigative Site
Busan, 48265
Novartis Investigative Site
Busan, 49201
Novartis Investigative Site
Busan, 49241
Novartis Investigative Site
Cheonan Si, Chungcheongnam-do, 31116
Novartis Investigative Site
Cheonan Si, Chungcheongnam-do, 31151
Novartis Investigative Site
Daegu, Daegu Jung Gu, 41940
Novartis Investigative Site
Daegu, Dalseo gu, 42602
Novartis Investigative Site
Daegu, 42415
Novartis Investigative Site
Daegu, 42472
Novartis Investigative Site
Daejeon, Korea, 35015
Novartis Investigative Site
Goyang-si, Gyeonggi-do, 10380
Novartis Investigative Site
Guri-si, Gyeonggi-do, 11923
Novartis Investigative Site
Gwangju, Gwangju, 61489
Novartis Investigative Site
Gwangju, 61469
Novartis Investigative Site
Gwangju, 61932
Novartis Investigative Site
Gyeonggi-do, 11765
Novartis Investigative Site
Iksan Si, Jeonlabuk Do, 54538
Novartis Investigative Site
Incheon, 22332
Novartis Investigative Site
Jeju City, 63206
Novartis Investigative Site
Jinju, Gyeongsangnam-do, 52727
Novartis Investigative Site
Pusan, 47392
Novartis Investigative Site
Seoul, Korea, 02841
Novartis Investigative Site
Seoul, Korea, 03312
Novartis Investigative Site
Seoul, Seoul, 03080
Novartis Investigative Site
Seoul, Seoul, 05030
Novartis Investigative Site
Seoul, Seoul, 06351
Novartis Investigative Site
Seoul, 01000
Novartis Investigative Site
Seoul, 03722
Novartis Investigative Site
Seoul, 04401
Novartis Investigative Site
Seoul, 04763
Novartis Investigative Site
Seoul, 05278
Novartis Investigative Site
Seoul, 05355
Novartis Investigative Site
Seoul, 05368
Novartis Investigative Site
Seoul, 06023
Novartis Investigative Site
Seoul, 06273
Novartis Investigative Site
Seoul, 07071
Novartis Investigative Site
Seoul, 07301
Novartis Investigative Site
Seoul, 07441
Novartis Investigative Site
Suwon, Gyeonggi-do, 16499
Novartis Investigative Site
Taegu, 41944
Novartis Investigative Site
Ulsan, 44033
Novartis Investigative Site
Yangsan, Gyeongsangnam-do, 50612
About this study
Official title: Regulatory Post-Marketing Surveillance (rPMS) Study for Brolucizumab(Beovu ® Injection, Beovu ®Prefilled Syringe)
This study is an open-label, multicenter, single-arm, observational post-marketing surveillance.
Read the 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.
- Being tested
- brolucizumab
- Keywords
- nAMD, Neovascularized age related macular degeneration, Beovu, regulatory Post Marketing Study, Beovu Injection, Beovu Prefilled Syringe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brolucizumabOther
Also called Beovu
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.
| Study group | Role | What they receive |
|---|---|---|
| Brolucizumab | Patients prescribed with brolucizumab in the approved indication Receives: Other: brolucizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events at 12 weeks
Incidence of adverse events and serious adverse events
Measured: 12 weeks
Secondary outcomes (17)
Incidence of adverse events at 24 weeks and optionally at 36 weeks
Incidence of adverse events and serious adverse events
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline, week 12, week 24, optionally week 36
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
Measured: Baseline, week 12, week 24, optionally week 36
Mean Central Subfield Thickness (CST)
CST is measured as one parameter by Optical coherence tomography.
Measured: Baseline, Week 12, week 24, optionally week 36
Number of injections
Number of Brolucizumab injections to be collected
Measured: Up to 36 weeks
Percentage of patients completing the loading phase
Loading phase: ≥ 3 injection during first 4 months
Measured: 4 months
Percentage of patients who maintained with 12 weeks interval
Percentage(%) of patients who maintained with 12 weeks interval
Measured: 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
Measured: 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
Measured: Baseline
Prior anti-VEGF treatment history - agent of prior injections
Agent of prior anti - vascular endothelial growth factor (VEGF) injections
Measured: 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
Measured: Week 24
Treatment naïve/non-naïve
Number of participants that are treatment naïve / non-naïve to be collected
Measured: Baseline
Treatment interval
Number of participants by treatment interval to be collected
Measured: Up to week 36
Concomitant treatments
Number of participants with concomitant treatments to be collected
Measured: 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.
Measured: Week 12, week 24, optionally week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2021
- Study start18 Aug 2021
- Primary completion14 Jun 2026
- Study completion14 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,369 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04985487
- Sponsor's protocol ID
- CRTH258AKR01
- Status last verified
- Nov 2026
- First submitted
- 22 Jul 2021
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulatory Post-Marketing Surveillance (rPMS) Study for Brolucizumab(Beovu ® Injection, Beovu ®Prefilled Syringe)
- ClinicalTrials.gov ID
- NCT04985487
- Acronym / sponsor ID
- CRTH258AKR01
- Keywords
- nAMD, Neovascularized age related macular degeneration, Beovu, regulatory Post Marketing Study, Beovu Injection, Beovu Prefilled Syringe
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,369 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2021 (actual)
- Primary completion
- 14 Jun 2026 (actual)
- Study completion
- 14 Jun 2026 (actual)
- First posted
- 2 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brolucizumab | – | Other: brolucizumabPatients prescribed with brolucizumab in the approved indication |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| brolucizumabAlso: BeovuProspective observational study. There is no treatment allocation. Patients administered brolucizumab, that have started before inclusion of the patient into the study will be enrolled. | Other | Brolucizumab |
Primary outcome
Incidence of adverse events at 12 weeks
Time frame: 12 weeks
Incidence of adverse events and serious adverse events
17 secondary outcomes
Incidence of adverse events at 24 weeks and optionally at 36 weeks
Time frame: Up to 36 weeks
Proportion of patients gaining or losing more than 15 letters on the ETDRS chart
Time frame: Week 12, week 24, optionally week 36
Mean change of Central Subfield Thickness (CST) from baseline
Time frame: Baseline, week 12, week 24, optionally week 36
Mean change of Best Corrected Visual Acuity (BCVA) from baseline
Time frame: Baseline, week 12, week 24, optionally week 36
Mean Best Corrected Visual Acuity (BCVA)
Time frame: Baseline, week 12, week 24, optionally week 36
Mean Central Subfield Thickness (CST)
Time frame: Baseline, Week 12, week 24, optionally week 36
Number of injections
Time frame: Up to 36 weeks
Percentage of patients completing the loading phase
Time frame: 4 months
Percentage of patients who maintained with 12 weeks interval
Time frame: Up to 36 weeks
Proportion of patients with retinal fluid
Time frame: Week 12, week 24, optionally week 36
Prior anti-VEGF treatment history - number of prior injections
Time frame: Baseline
Prior anti-VEGF treatment history - agent of prior injections
Time frame: Baseline
Predictive factors of treatment outcomes (persistent disease activity)
Time frame: Week 24
Treatment naïve/non-naïve
Time frame: Baseline
Treatment interval
Time frame: Up to week 36
Concomitant treatments
Time frame: Baseline
Number of participants with post injection empirical treatment
Time frame: Week 12, week 24, optionally week 36
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
45 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neovascular Age-related Macular Degeneration, run by Novartis Pharmaceuticals at 45 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events at 12 weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.