A Study to Evaluate the Usability of the SB11 PFS in Subjects With Wet AMD or Macular Oedema Secondary to RVO: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study to Evaluate the Usability of the SB11 PFS in Subjects With Wet AMD or Macular Oedema Secondary to RVO (NCT06176963), a na phase 2 study. The primary outcome is Percentage of Successful Task Completions.

2. Clinical Question

In statistical terms, the study asks about performance during a specified use procedure, not about a difference in clinical outcomes between treatments. Its direct evidence concerns task completion by the participating healthcare professionals in the enrolled patients. It does not estimate a treatment contrast, because no control group was included. The registry record describes a study of usability in people with two stated condition categories; it does not report separate primary endpoint results for those categories.

3. Trial Design

This was a Phase II, open-label, single-group, single-dose clinical study of the SB11 pre-filled syringe. The registry record gives the study status as completed and reports enrollment of 34. The study start date was 2023-11-21, and the primary completion date was 2023-11-30. Samsung Bioepis Co., Ltd. is listed as the sponsor.

Healthcare professionals followed the instructions for use to prepare and administer SB11 by intravitreal injection. The described dose was 0.5 mg ranibizumab in 0.05 mL solution, with one injection per enrolled patient. The registry record reports that four participating healthcare professionals performed tasks on the 34 enrolled patients. They had sufficient time to review the instructions for use before performing the procedure on Day 1, and they did not receive additional training for the pre-filled syringe before or during the study.

The design was not randomized and did not include a like-for-like control group. The registry record lists no allocation and no masking. Consequently, the study is descriptive for the recorded use procedure: it can characterize task completion under the stated study conditions, but it cannot estimate a between-group treatment effect. The open-label design also means that the task assessment was not conducted under masking, as far as the registry record reports.

The conditions listed are neovascular age-related macular degeneration, macular edema, and retinal vein occlusion. The brief summary refers to neovascular age-related macular degeneration or macular oedema secondary to retinal vein occlusion. The registry record does not report the distribution of enrolled patients between those condition categories, nor does it report separate outcomes by category.

Further details that might clarify how the study was planned or conducted—including the statistical analysis plan, eligibility criteria, and any interim analyses—are not reported in the registry record. The record lists no analyses. That absence limits what can be concluded about the planned handling of the observations and the analysis populations.

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.

Before assignment: 34 subjects were enrolled for this study and 4 HCPs participated in this study.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Overall, 4 participating HCPs performed tasks on 34 enrolled patients (a single PFS ITV injection per patient) leading to a total of "34 attempts" for each tasks in this study.

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: 34 subjects were enrolled in the study.

6. Primary Endpoint

The registry lists the primary outcome as Percentage of Successful Task Completions, measured over Day 1.

The primary endpoint was the percentage of successful task completions, assessed on Day 1. The registry record says that 12 tasks were evaluated during preparation and administration of the intravitreal injection. The participating healthcare professionals had time to review the instructions for use, but received no additional training for the pre-filled syringe before or during the study.

The endpoint expresses successful task completions relative to task attempts. The registry record describes 34 attempts for each task, arising from the healthcare professionals performing tasks on 34 enrolled patients. It uses a percentage because each administration procedure was divided into tasks, and the intended summary was the share of attempts classified as successful. This gives a procedural usability measure rather than a measure of change in a patient’s clinical condition.

As a general statistical point, a proportion is interpretable only in relation to its definition and denominator. Here, the stated task-level denominator is attempts, not a count of distinct healthcare professionals. A task completion percentage can therefore describe how often a task was completed successfully across the recorded attempts, but it does not by itself explain why a task failed or how performance varied between professionals.

The registry record does not report the numerical value of the primary endpoint, task-specific results, or criteria used to judge success. As a result, the endpoint’s definition is available, but its observed performance cannot be assessed from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record describes an endpoint based on the percentage of successful task completions. It does not report the numerical endpoint result or any analyses. The explanations below distinguish general statistical principles from methods that can be confirmed from the registry record.

What does a task-completion percentage represent?

As a general statistical concept, a percentage is a way to express a count relative to a defined total. In this study, the stated unit was successful task completion, with 12 tasks evaluated and 34 attempts for each task. The percentage is intended to summarize successful completions relative to attempts. The registry record does not provide the successful counts or percentages, so the observed value cannot be reconstructed or interpreted.

The denominator matters. An attempt is not the same unit as a healthcare professional, and repeated attempts from the same professional or procedure may be related. A percentage across attempts gives an overall summary, but it can conceal differences between tasks and users. Task-specific counts and results by professional are not reported in the registry record.

Why can repeated observations affect uncertainty?

As a general statistical principle, observations that share a user, setting, or procedure may be correlated. If a professional tends to perform several tasks similarly, outcomes from those tasks can carry overlapping information. Methods that account for clustering can produce uncertainty estimates that reflect this dependence. The registry record does not report whether clustering was considered or what method, if any, was used to estimate uncertainty.

When observations are independent and the outcome is a proportion, standard approaches can estimate the uncertainty around that proportion. When observations are dependent, those approaches may not adequately represent the data structure. The appropriate method depends on the actual observations and the analysis plan; it cannot be selected from the endpoint title alone. No standard error, confidence interval, or other precision estimate is reported in the registry record.

What would a confidence interval add?

As a general explanation, a confidence interval communicates the statistical uncertainty around an estimate under a specified model and sampling process. It is not a guarantee that the true value lies within the interval, and its interpretation depends on the method used to calculate it. For task completion, an interval could help show the precision of an estimated percentage. No such interval or underlying estimate is reported in the registry record, so the precision of the primary endpoint cannot be assessed.

Precision also depends on the number and structure of observations, not merely on a total count. The registry record reports 34 patients and four participating healthcare professionals, with attempts described for each task. The professional-level count is relevant because observations from a small group of users may not represent the range of performance across other users. The record does not report user-level variation or an analysis designed to generalize across professionals.

What does the single-group design permit?

As a general design principle, a single-group study can describe outcomes observed under its study conditions. A control group is needed for a direct comparison between groups, and random allocation helps support causal interpretation of such a comparison. This study had one group, with no allocation and no masking reported. It therefore does not estimate a difference between the pre-filled syringe and an alternative device, procedure, or training approach.

The absence of a comparator does not make a descriptive endpoint meaningless, but it limits the question the data can answer. An observed task-completion percentage, if reported, would characterize the study procedures and participants. It would not establish how the same healthcare professionals would have performed using a different product or instructions.

What can sample-size calculations say?

As a general statistical concept, sample-size calculations are planning tools that depend on assumptions about the effect to be detected, variability, significance level, allocation, and analysis method. The registry record’s stated planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect expressed as a stated fraction of the observed effect. The record identifies these as planning illustrations, not as the trial’s own design.

Those assumptions do not turn this single-group usability study into a two-arm comparison. Planning illustrations are not observed power, and they cannot establish that the study had a particular probability of detecting an effect. The registry record lists no analyses and does not report a primary endpoint estimate, so such illustrations cannot be connected to an observed task-completion result.

What analysis details remain unknown?

The registry record does not report whether the endpoint was analyzed using a particular statistical model, whether confidence intervals or hypothesis tests were planned, or whether any adjustment was made for multiple tasks. It also does not report how missing or unevaluable task attempts were handled, how success was defined for each task, or which analysis population was used. These details matter because definitions and analysis choices can affect a proportion and its uncertainty. They should not be inferred from the description of the endpoint.

10. Multiplicity, Missing Data and Analysis Populations

The primary endpoint concerns successful completion across 12 evaluated tasks. The registry record also lists secondary outcomes for successful completion on critical tasks and essential tasks. Evaluating several outcomes or task groupings can raise a multiplicity question: when many statistical claims are tested, the chance of at least one apparently notable result can increase. As a general statistical approach, a prespecified analysis plan may define which outcomes are primary and whether adjustment is needed. The registry record does not report a multiplicity adjustment, a testing hierarchy, or a statistical analysis plan. It also reports no analyses, so there are no posted inferential results to assess for multiplicity.

Missing-data handling is likewise not reported in the registry record. It does not state whether all task attempts were evaluable, how incomplete procedures were treated, or whether observations could be excluded. The fact that 34 attempts are described for each task does not establish whether there were missing data or how any such data were handled. No assumption about completeness should be made from the endpoint description.

The analysis populations are not reported in the registry record. The record identifies 34 enrolled patients and four participating healthcare professionals, but does not specify a population for analysis or describe exclusions from an analysis set. These are distinct questions: enrollment identifies who entered the study, while an analysis population defines whose observations contribute to a particular result. Without the latter information and without numerical outcome results, the composition of the analyzed data cannot be verified.

There is also no reported method for handling the dependence of multiple task observations within procedures or professionals. This is separate from missing data and multiplicity, but relevant to inference about task-completion percentages. The registry record does not give enough detail to determine how these issues were addressed.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

The registry record reports zero serious adverse events among 34 participants at risk in the SB11 pre-filled syringe group. It reports two other adverse events among 34 participants at risk and zero deaths. These are counts as recorded; no event terms are listed for serious adverse events.

Counts should be read in context. The zero serious adverse event count means none were recorded in this group during the reported study record; it does not establish that serious events cannot occur. The two other adverse events are not described by type, timing, or relationship to the intervention in the information. No rates or comparative safety estimates are reported, and there is no control group for comparison.

As a general statistical point, safety counts from a study of this size and design describe events observed in the enrolled group; they do not by themselves provide a precise estimate of the frequency of uncommon events or establish a causal relationship. The registry record does not report additional details needed to interpret the two other events or assess their severity and attribution. The figures should therefore be treated as descriptive registry counts, not as a complete characterization of safety.

12. What the Result Does, and Does Not, Mean

This study addresses a focused usability question: how healthcare professionals completed tasks while preparing and administering SB11 from a pre-filled syringe according to its instructions for use. It reports an open-label, single-group procedure involving 34 enrolled patients and four participating healthcare professionals. The primary endpoint was defined as the percentage of successful task completions across the evaluated tasks on Day 1.

The registry record does not report the numerical primary endpoint result. Consequently, it does not allow readers to determine the observed success percentage, compare performance among tasks, or assess the precision of an estimate. It also does not report task-specific success criteria or reasons for any unsuccessful completion. The record lists no analyses.

The study does not compare SB11 with another product or procedure. With no randomized comparator, its design cannot estimate a between-group difference or isolate the effect of the device relative to an alternative. Its findings, if numerical results were available, would be descriptive of task completion under the study conditions rather than evidence of comparative usability.

The record also does not report whether performance differed by healthcare professional or by the enrolled patients’ condition category. Four participating professionals and the stated study procedures describe the scope of the observations, but the registry record does not establish how representative those participants or conditions are of other settings. Additional details about user experience, analysis populations, missing data, and endpoint criteria are not reported in the registry record.

Thus, the registry record establishes the study question, design, and endpoint definition, and it reports limited adverse event counts. It does not provide the primary outcome estimate needed to judge observed task performance. It should not be read as evidence of a treatment effect or as a complete account of usability or safety.

13. Why This Trial Matters Statistically

Usability is a distinct statistical question from whether a treatment changes a clinical outcome. This study operationalized usability through task completion during preparation and administration of a pre-filled syringe. That makes the endpoint a measure of performance in a specified procedure, rather than a patient-level measure of clinical benefit.

The record also illustrates why endpoint definitions and results must be considered together. It identifies 12 tasks and describes the denominator as attempts, with 34 attempts for each task. Yet the numerical primary endpoint result and task-level results are not reported. Without those values, readers can understand what was intended to be measured but cannot evaluate the observed performance or its precision.

The study’s design limits the types of statistical conclusions available. A single group can support description of outcomes in that group, but no control group means there is no direct estimate of a difference from an alternative. The open-label design and the participation of four healthcare professionals are also important context for interpreting any procedural assessment. The registry record does not report analyses that address variation among professionals or dependence among tasks.

For biostatisticians and clinical researchers, the record is a reminder to distinguish a planned or defined endpoint from a posted result. It also emphasizes the importance of reporting analysis methods, success criteria, missing-data handling, analysis populations, and uncertainty estimates. Those details are not reported in the registry record. The study’s subject is relevant to trial conduct and device use, but the available record supports only a limited statistical reading of the intended measurement and reported counts.

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.

A central limitation is that the numerical primary endpoint result is not reported in the registry record. The record defines successful task completion as the endpoint but does not give the observed percentage, task-specific counts, or a measure of uncertainty. As a result, the study’s main usability outcome cannot be quantitatively interpreted from the registry record.

The design was open-label and single-group, with no allocation to a comparator. It therefore provides no controlled estimate of relative performance. The task observations were made by four participating healthcare professionals across 34 enrolled patients. The registry record does not report whether analysis accounted for possible clustering of tasks within professionals or procedures, or how much performance varied between professionals.

The healthcare professionals were given sufficient time to review the instructions for use and did not receive additional training for the pre-filled syringe before or during the study. Those conditions define the context of the assessment, but information about professional experience, recruitment, or representativeness is not reported in the registry record. Results by patient condition category are also not reported.

The record does not report task-specific definitions of success, reasons for unsuccessful tasks, missing-data handling, analysis populations, statistical methods, or multiplicity procedures. It lists no analyses. The absence of these details makes it difficult to assess how observations were classified and how any potential uncertainty or dependence was handled.

Finally, safety information is limited to the reported counts: zero serious adverse events, two other adverse events, and zero deaths in the group. Serious event terms and descriptions of the other events are not reported in the registry record. These counts are descriptive and cannot establish comparative safety.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: A Study to Evaluate the Usability of the SB11 PFS in Subjects With Wet AMD or Macular Oedema Secondary to RVO — NCT06176963.
• Registry record last updated 2024-12-30; status last verified 2024-12.
• Results first posted 2024-12-30.
• 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.

18. Record Summary

NCT06176963 was a completed, open-label, single-group, single-dose Phase II study sponsored by Samsung Bioepis Co., Ltd. It enrolled 34 patients with neovascular age-related macular degeneration or macular oedema secondary to retinal vein occlusion. Four healthcare professionals used the SB11 pre-filled syringe, containing 0.5 mg ranibizumab in 0.05 mL solution, for a single intravitreal injection per patient on Day 1.

The primary endpoint was the percentage of successful task completions across 12 tasks. The registry record describes 34 attempts for each task but does not report the numerical primary endpoint result or any analyses. It reports zero serious adverse events, two other adverse events, and zero deaths among 34 participants at risk. The record does not report a comparator, task-specific results, analysis methods, missing-data handling, or analysis populations.