This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Study of Safety and Efficacy of Brolucizumab 6 mg Drug Product Intended for Commercialization in Patients With nAMD (NCT03386474), a non-randomized phase 3 study. The primary outcome is Number of Participants With Ocular and Non-Ocular Treatment Emergent Adverse Events.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03386474 |
| Phase | Phase 3 |
| Condition | Neovascular Age-related Macular Degeneration |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 151 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Novartis Pharmaceuticals |
| Results posted | Yes |
2. Clinical Question
The study concerned people with neovascular age-related macular degeneration (nAMD) who had completed the CRTH258A2301 core study. Its purpose was to collect safety and efficacy data on a new formulation of brolucizumab 6 mg intended for commercialization. The primary outcome focused on participants with ocular or non-ocular treatment-emergent adverse events during the extension.
Population
People with nAMD who had completed the CRTH258A2301 core study. The brolucizumab extension safety set included participants who received at least one brolucizumab 6 mg injection.
Intervention
Brolucizumab 6 mg solution for intravitreal injection. The described schedule included injections at Day 1, Week 8, and Week 16 or Week 20.
Comparator
Aflibercept 2 mg was also listed. Its injections at Day 1, Week 8, and Week 16 were described as maintaining masking for the extension only; allocation was non-randomized, so the arms are not a like-for-like control comparison.
Primary question
How many participants had ocular or non-ocular treatment-emergent adverse events with the new brolucizumab formulation through Week 24, compared with the corresponding last six months of brolucizumab treatment in the core study?
The primary outcome was framed as a within-patient comparison of brolucizumab safety experience across the extension and the corresponding period in the core study. The registry says results were presented descriptively for brolucizumab, in line with the study objective, and that no formal hypothesis testing was planned. This is different from a randomized trial question asking whether one treatment produces better outcomes than another under comparable allocation.
The registry also lists secondary outcomes involving visual acuity, central sub-field thickness, treatment status, and anti-drug antibody status. The existence of those outcomes does not by itself establish what their results were. The primary endpoint information described in the record concerns adverse-event counts, not a formal efficacy comparison.
3. Trial Design
This was a phase 3, multicenter, two-arm extension study with a planned duration of 24 weeks. The registry lists it as completed, with enrollment of 151. The study was intended for participants with nAMD who had completed the CRTH258A2301 core study, also identified as CRTH258-C002 in the study summary. The trial title and summary describe collection of safety and efficacy information for a new formulation of brolucizumab 6 mg.
The design was parallel and non-randomized, with triple masking recorded in the registry. Non-randomized allocation is important to interpretation: the two arms cannot be treated as exchangeable groups simply because both appear in the record. The description of the aflibercept injections says they were used to maintain masking of the extension trial only. The registry explicitly cautions that the arms are not a like-for-like control comparison.
The brolucizumab arm received 6 mg solution by intravitreal injection at Day 1, Week 8, and Week 16 or Week 20, according to the arm description. The aflibercept arm received 2 mg injections at Day 1, Week 8, and Week 16. The registry’s primary safety population was the brolucizumab extension safety set: participants who received at least one injection of brolucizumab 6 mg. Adverse-event information also lists an aflibercept group, but that does not convert the extension into a randomized comparative trial.
The registry records a study start date of 2018-01-15 and a primary completion date of 2018-09-06. It gives the study status as completed. Further details about the allocation process, including how participants entered each arm, are not reported in the registry record. The protocol’s rationale for the selected enrollment and any sample-size justification are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Brolucizumab - Overall Extension Study | Aflibercept |
|---|---|---|
| STARTED | 107 | 43 |
| COMPLETED | 106 | 42 |
| NOT COMPLETED | 1 | 1 |
Reasons for not completing this period:
| Reason | Brolucizumab - Overall Extension Study | Aflibercept |
|---|---|---|
| Death | 1 | 0 |
| Adverse Event | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: Brolucizumab extension safety set included subjects who received at least one injection of brolucizumab 6mg. Data was presented descriptively for only brolucizumab in line with the study objective. No formal hypothesis testing was planned.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: The Extension safety set includes all subjects who entered the extension study and received at least one injection of study treatment in this extension study.
| Characteristic | Unit | Brolucizumab - Overall Extension Study | Aflibercept | Total |
|---|---|---|---|---|
| Participants analysed | 107 | 43 | 150 | |
| Age, Continuous | years | 80.6 (SD 8.63) | 77.9 (SD 9.20) | 79.8 (SD 8.85) |
| Sex: Female, Male: Female | Participants | 69 | 22 | 91 |
| Sex: Female, Male: Male | Participants | 38 | 21 | 59 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 11 | 6 | 17 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 95 | 37 | 132 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 1 | 0 | 1 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Ocular and Non-Ocular Treatment Emergent Adverse Events, measured over Up to Week 24.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint counts participants with ocular and non-ocular treatment-emergent adverse events. Its stated timeframe is up to Week 24. The registry describes the endpoint as assessing events with the new formulation of brolucizumab 6 mg in the extension against the corresponding last six months of brolucizumab treatment in the core study. This is a safety outcome expressed as a participant count, rather than a measure of event severity, duration, or change in visual function.
Participant counts are useful for describing how many people in the defined safety set experienced an event. They make the extent of reported event experience visible in the study population, but do not by themselves show whether an event was caused by treatment. The registry’s outcome description does not establish causation, and the count does not communicate how many events each participant experienced.
The stated rationale is specific to the extension: assess the safety of the new formulation using a within-patient comparison with the corresponding core-study period. That approach relates each participant’s extension experience to their own prior treatment period, rather than treating the aflibercept arm as a randomized control. The registry says results were presented descriptively for brolucizumab and that no formal hypothesis testing was planned. Consequently, the endpoint is best read as descriptive safety information, not as a test of whether one treatment is safer than another.
The registry description also says missing brolucizumab data were imputed using last observation carried forward (LOCF). It does not report the amount or pattern of missing data, or further operational details about how events were defined and classified.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The primary outcome is a participant count for ocular and non-ocular treatment-emergent adverse events, assessed through Week 24. The registry frames the brolucizumab safety assessment as a within-patient comparison with the last six months of corresponding brolucizumab treatment in the core study. It reports 107 participants at risk in each of the two brolucizumab safety periods. Seven participants were recorded with serious adverse events in each period. For other adverse events, the registry records 12 participants in the extension and 14 in the corresponding core-study period. These are descriptive counts; the record states that no formal hypothesis testing was planned.
The matching number at risk in those brolucizumab periods makes the counts straightforward to read as reported, but it does not establish that missingness, exposure, or event ascertainment were identical. The record says missing brolucizumab data were handled with LOCF, but does not give the number of missing observations or explain their timing. Without those details, the influence of imputation on the reported event counts cannot be assessed from the registry record.
The adverse-event information also lists an aflibercept group, with 43 participants at risk, 10 participants with serious adverse events, and 13 with other adverse events. This group should not be used as a direct comparative control. The study allocation was non-randomized, and the registry cautions that the arms are not a like-for-like control comparison. The aflibercept injection schedule is described as serving to maintain masking of the extension only. Differences between the groups could reflect differences in who entered each arm or other features not described in the registry, rather than treatment effects.
The registry records one death in the brolucizumab extension group, zero in the brolucizumab core-period group, and zero in the aflibercept group. These are counts in the listed groups; the record does not provide a causal attribution in the reported figures. It also lists Syncope at 7.0% and Anaemia macrocytic, Lymphadenopathy, Left ventricular failure, Pyrexia, and Cholelithiasis at 2.3% each among the top serious terms. The registry excerpt does not specify the denominator or group attribution for those term percentages, so they should not be assigned to a particular group based on those figures alone.
Confidence intervals, comparative effect estimates, and p-values for the primary outcome are not reported in the registry record. The absence of a formal hypothesis test means these counts do not establish statistical evidence for a difference between the brolucizumab periods or between treatment arms. They describe recorded events in the specified populations and follow-up periods. Any planning illustrations based on an observed effect are not observed power and cannot replace the study’s descriptive results or an inferential analysis.
9. Statistical Methods Explained
Statistical methods need to be interpreted in light of the study question and design. This extension had a safety-focused primary outcome: the number of participants with ocular and non-ocular treatment-emergent adverse events through Week 24. The registry says the brolucizumab assessment used a within-patient comparison with the corresponding last six months of brolucizumab treatment in the core study. It also says the data were presented descriptively and that no formal hypothesis testing was planned. The record does not report a statistical analysis plan beyond those statements.
What does a participant count describe?
A participant count records how many people in a defined group experienced the event category. It is not the same as a count of all event episodes: one participant may experience more than one event, while the participant count still counts that person once for the relevant outcome. Counts depend on the population included and the observation period. They do not, by themselves, account for differences in time under observation, explain why an event occurred, or quantify uncertainty around the count.
General statistical context: a rate can be useful when people have different amounts of time at risk, because it relates events to exposure time. The registry’s primary outcome is described as a number of participants, and an exposure-adjusted rate is not reported in the registry record. General context: an interval estimate can convey the range of values reasonably compatible with data under a specified statistical model. A confidence interval for the primary outcome is not reported in the registry record, so the precision of an estimated effect cannot be assessed from an interval.
Why does the allocation matter?
The study is recorded as non-randomized. In a randomized comparison, allocation by chance is intended to make treatment groups comparable on average, including on factors that may affect outcomes. Non-randomized allocation does not offer that same design protection. Differences between arms may arise from participant characteristics, prior treatment history, selection into the arm, or other factors, whether or not treatment contributes to the outcome. The registry does not give enough detail to evaluate the allocation process or adjust for possible differences between the arms.
For that reason, the listed aflibercept counts are not a like-for-like control comparison with the brolucizumab counts. The record says aflibercept was used to maintain masking of the extension only. The primary safety description instead centers on brolucizumab and its corresponding core-study period. A within-patient comparison can control for characteristics that remain stable within a person, but it does not automatically control for changes over time, differences in exposure, or changes in how outcomes are recorded. The registry does not report a formal model for a within-patient contrast.
What does descriptive analysis imply?
Descriptive analysis presents observed data without claiming that a formal statistical test has established a difference. It is appropriate to read the reported counts as a record of the events in the stated groups and periods. The registry explicitly says no formal hypothesis testing was planned. P-values, adjusted estimates, and model-based comparisons for the primary safety endpoint are not reported in the registry record.
General statistical context: a p-value, when used, addresses how compatible observed data are with a specified null model, conditional on the assumptions of the analysis. It is not a measure of clinical importance or the probability that a treatment works. No primary-endpoint p-value is reported, so no such inferential conclusion can be drawn from the record. Likewise, the absence of a test is not proof that groups or periods are equivalent.
How should missing data be considered?
The registry states that missing brolucizumab data were imputed using last observation carried forward (LOCF). In general, LOCF carries the last observed value forward to a later assessment when data are missing. This method makes an assumption that the carried-forward observation is a reasonable substitute for the missing value. That assumption may be questionable if a participant’s status changes after the last observation. The registry does not report how many observations were missing, why they were missing, whether missingness differed across periods, or any sensitivity analysis using alternative assumptions.
General statistical context: over-dispersion matters when variation in count data exceeds what a simple count model assumes; a model that ignores extra variation can understate uncertainty. The primary outcome is described as a participant count and the registry does not report a count model, an over-dispersion assessment, or a model-based interval. This concept is therefore relevant as general background, not as a claim about an analysis performed in this study.
What can planning calculations tell readers?
Any sample-size illustration based on an observed effect is a planning exercise, not observed power. Such an illustration depends on assumptions about the target effect, significance level, allocation, and statistical approximation. The registry record does not report the trial’s own sample-size justification, nor does it report a planned formal hypothesis test for the primary outcome. Planning values therefore should not be interpreted as the study’s achieved power or as evidence that the study did or did not detect an effect.
Multiplicity concerns arise when several outcomes or comparisons are tested, because the chance of at least one false-positive result can rise as tests accumulate. The registry lists secondary outcomes, but a multiplicity adjustment or testing hierarchy is not reported in the registry record. Since no formal hypothesis testing was planned for the primary safety outcome, multiplicity procedures should not be assumed.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists secondary outcomes on visual acuity, central sub-field thickness, treatment status, and anti-drug antibody status, in addition to the primary safety outcome. It does not report a hierarchy for testing these outcomes, a multiplicity adjustment, or a statistical plan for controlling the chance of false-positive findings across multiple tests. The primary safety outcome is explicitly described as descriptive, with no formal hypothesis testing planned. A testing strategy for secondary outcomes is not reported in the registry record.
Missing brolucizumab data were imputed using last observation carried forward. That statement describes the method, but not how much data were missing, when observations were missing, or the reasons for missingness. Those details matter because missing data can affect which participants contribute information and how representative the analyzed observations are. The registry record does not report sensitivity analyses to examine alternative missing-data assumptions, nor does it report an analysis comparing results with and without imputation.
The primary population is defined as the brolucizumab extension safety set, including participants who received at least one brolucizumab 6 mg injection. The registry also records 107 participants at risk in the brolucizumab extension group and 107 in the corresponding last six months of the core study. Details of other analysis populations, including any efficacy analysis population and how participants were handled for each secondary outcome, are not reported in the registry record.
The enrollment is recorded as 151, but the record does not explain how that enrollment relates to each analysis population or why participants may not appear in every listed group. No additional assumptions about analysis-set membership or missingness should be inferred from the counts alone.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Brolucizumab 6mg Overall Extension Study | 7 | 107 | 6.5% |
| Brolucizumab Overall Last 6 Months Core Study | 7 | 107 | 6.5% |
| Aflibercept 2 mg | 10 | 43 | 23.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Brolucizumab 6mg Overall Extension Study | 1 of 107 |
| Brolucizumab Overall Last 6 Months Core Study | 0 of 107 |
| Aflibercept 2 mg | 0 of 43 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Brolucizumab 6mg Overall Extension Study | 12 of 107 |
| Brolucizumab Overall Last 6 Months Core Study | 14 of 107 |
| Aflibercept 2 mg | 13 of 43 |
Most frequent serious adverse event terms
| Event term | Organ system | Brolucizumab 6mg Overall Extension Study | Brolucizumab Overall Last 6 Months Core Study | Aflibercept 2 mg |
|---|---|---|---|---|
| Syncope | Nervous system disorders | 0 of 107 | 0 of 107 | 3 of 43 |
| Pneumonia | Infections and infestations | 1 of 107 | 0 of 107 | 1 of 43 |
| Femur fracture | Injury, poisoning and procedural complications | 1 of 107 | 1 of 107 | 0 of 43 |
| Anaemia macrocytic | Blood and lymphatic system disorders | 0 of 107 | 0 of 107 | 1 of 43 |
| Lymphadenopathy | Blood and lymphatic system disorders | 0 of 107 | 0 of 107 | 1 of 43 |
| Cardiac failure congestive | Cardiac disorders | 1 of 107 | 0 of 107 | 0 of 43 |
| Left ventricular failure | Cardiac disorders | 0 of 107 | 0 of 107 | 1 of 43 |
| Retinal artery occlusion - Study eye | Eye disorders | 1 of 107 | 0 of 107 | 0 of 43 |
| Retinal vein occlusion - Study eye | Eye disorders | 1 of 107 | 0 of 107 | 0 of 43 |
| Multiple organ dysfunction syndrome | General disorders | 1 of 107 | 0 of 107 | 0 of 43 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Brolucizumab 6mg Overall Extension Study | Brolucizumab Overall Last 6 Months Core Study | Aflibercept 2 mg |
|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | 4 of 107 | 6 of 107 | 6 of 43 |
| Nasopharyngitis | Infections and infestations | 5 of 107 | 4 of 107 | 3 of 43 |
| Neovascular age-related macular degeneration - Fellow eye | Eye disorders | 2 of 107 | 2 of 107 | 3 of 43 |
| Cataract - Fellow eye | Eye disorders | 1 of 107 | 1 of 107 | 3 of 43 |
| Haematuria | Renal and urinary disorders | 0 of 107 | 1 of 107 | 3 of 43 |
Serious events with the highest arm-level rate: syncope (7.0%), anaemia macrocytic (2.3%), lymphadenopathy (2.3%), left ventricular failure (2.3%), pyrexia (2.3%).
The registry lists serious and other adverse-event participant counts for three groups. In the brolucizumab extension group, 107 participants were at risk; 7 had serious adverse events and 12 had other adverse events. In the brolucizumab last-six-months core-study group, 107 participants were at risk; 7 had serious adverse events and 14 had other adverse events. In the aflibercept group, 43 participants were at risk; 10 had serious adverse events and 13 had other adverse events. The record also lists deaths: 1 in the brolucizumab extension group, 0 in the brolucizumab core-period group, and 0 in the aflibercept group.
These figures are counts, not estimates of causal risk. The registry does not state in these figures whether an event was judged related to treatment. Nor does it provide an exposure-adjusted comparison or a formal statistical test. The aflibercept arm is non-randomized and is explicitly not a like-for-like control comparison, so its counts should not be read as a direct treatment contrast with brolucizumab.
The record lists Syncope at 7.0% and Anaemia macrocytic, Lymphadenopathy, Left ventricular failure, Pyrexia, and Cholelithiasis at 2.3% each among top serious terms. The denominator and group attribution for these term percentages are not reported in the registry record. They should be read as listed serious-event terms, not as a complete account of all safety findings.
12. What the Result Does, and Does Not, Mean
The results describe safety events recorded in a short extension among participants who had completed the CRTH258A2301 core study. The primary outcome concerns the number of participants with ocular and non-ocular treatment-emergent adverse events through Week 24. The brolucizumab data are presented descriptively, and the record states that no formal hypothesis testing was planned. Readers can use the reported counts to understand what was observed in the defined groups and periods, but the counts alone do not quantify uncertainty or establish a treatment effect.
The brolucizumab extension and core-period groups each list 107 participants at risk, with 7 participants recorded as having serious events in each period. The other-event counts are 12 in the extension and 14 in the core period. Those figures do not, on their own, establish that safety was the same or different across periods. A formal comparison, including its assumptions and uncertainty, is not reported in the registry record. The use of LOCF for missing brolucizumab data also means the counts should be interpreted in light of an imputation method whose impact cannot be assessed without missing-data details.
The aflibercept results do not answer a randomized comparative question. Allocation was non-randomized, and the registry says the arms are not a like-for-like control comparison. A difference in counts between arms could reflect factors other than treatment. The aflibercept schedule was described as supporting masking of the extension only, rather than establishing a randomized efficacy or safety control.
These safety figures do not establish whether events were caused by a treatment, how severe or persistent they were, or how the new formulation compares with other treatment options. A participant count also does not show the total number of events when an individual can have more than one event. The registry does not report a formal inferential analysis of the primary endpoint, confidence intervals, or a complete accounting of missingness.
The study’s secondary outcomes include visual-acuity and anatomical measures as well as treatment-status and antibody measures, but the presence of those outcomes does not establish their findings. The safety-focused information described in the record should not be used to make medical decisions. It is a descriptive account of events within this extension study and its stated populations.
13. Why This Trial Matters Statistically
This study is statistically informative because it illustrates how an extension study can address a different question from a conventional randomized treatment comparison. Participants had completed a core study, and the extension’s stated aim was to collect safety and efficacy data on a new brolucizumab formulation. Its primary safety assessment compared the extension period with the corresponding last six months of brolucizumab treatment in the core study. That framing makes the within-patient nature of the safety question central to interpretation.
The distinction between descriptive and inferential analysis is especially important. The registry gives participant counts and states that no formal hypothesis testing was planned for the primary safety assessment. Descriptive counts can document events without establishing that observed differences are larger than would be expected from chance variation, nor do they quantify the precision of a contrast. The record does not report a confidence interval or a formal model for the comparison.
The study also demonstrates why masking and randomization should not be conflated. Triple masking is recorded, and the aflibercept schedule is described as maintaining masking, but allocation was non-randomized. Masking can reduce some forms of bias in care or assessment; it does not make treatment groups comparable by itself. The registry specifically cautions that the arms are not a like-for-like control comparison.
Finally, the missing-data approach is consequential for interpretation. LOCF is named for missing brolucizumab data, but the extent and pattern of missingness and the results of sensitivity analyses are not reported. Those omissions limit the ability to judge how robust the descriptive outcome is to assumptions about unavailable observations. Together, these features make the study useful as a safety description in an extension setting while limiting the strength of comparative conclusions that can be drawn from its registry results.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The non-randomized allocation is a key limitation for between-arm interpretation. The registry warns that the arms are not a like-for-like control comparison, and the aflibercept injections are described as serving to maintain masking of the extension only. Therefore, counts from the aflibercept group cannot be treated as a clean estimate of what would have happened to otherwise comparable participants receiving a different treatment.
The primary safety assessment is descriptive. The registry states that no formal hypothesis testing was planned, and it does not report a comparative estimate, confidence interval, or p-value for the primary endpoint. This limits assessment of statistical precision and means the observed counts should not be taken as proof of equivalence or a difference. Sample-size justification is not reported in the registry record.
Missing brolucizumab data were imputed using LOCF, but the amount, timing, and reasons for missingness are not reported. Sensitivity analyses are not reported in the registry record. Without these details, it is not possible to determine how dependent the recorded counts are on the imputation assumption.
The record gives the number of participants with events, but does not provide exposure-adjusted rates or detailed event-level information in the figures described. It does not specify the denominator or group attribution for the listed serious-term percentages. Causal attribution, event duration, and a detailed operational definition for the event categories are not reported in the registry record.
The study population was drawn from people who completed the CRTH258A2301 core study, and the primary safety set required at least one brolucizumab injection. This population and follow-up context should be kept in mind when considering how broadly the results apply. Further details about eligibility, participant flow, analysis populations, and any interim analyses are not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study of Safety and Efficacy of Brolucizumab 6 mg Drug Product Intended for Commercialization in Patients With nAMD — NCT03386474.
- Registry record last updated 2021-01-05; status last verified 2020-03.
- Results first posted 2020-04-30.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT03386474 is a completed phase 3, non-randomized, triple-masked, parallel extension study in people with neovascular age-related macular degeneration who completed the CRTH258A2301 core study. The registry records enrollment of 151 and a 24-week study intended to collect safety and efficacy data on a new brolucizumab 6 mg formulation intended for commercialization.
The primary outcome was the number of participants with ocular and non-ocular treatment-emergent adverse events through Week 24, with a within-patient reference to the corresponding last six months of brolucizumab treatment in the core study. The brolucizumab safety set included participants who received at least one injection. The registry says data were presented descriptively and no formal hypothesis testing was planned. Missing brolucizumab data were imputed using LOCF.
Adverse-event counts are listed for the brolucizumab extension, the brolucizumab core-study period, and an aflibercept group. The aflibercept arm is not a like-for-like control comparison because allocation was non-randomized. The record does not report the primary endpoint’s inferential estimates, confidence intervals, or a sample-size justification.