Study to Compare Efficacy, Safety, and Immunogenicity of LUBT010 (Proposed Ranibizumab Biosimilar) and Lucentis® in Patients With Neovascular AMD: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Study to Compare Efficacy, Safety, and Immunogenicity of LUBT010 (Proposed Ranibizumab Biosimilar) and Lucentis® in Patients With Neovascular AMD (NCT04690556), a randomized phase 3 study. The primary outcome is Mean Change in BCVA From Baseline in the Study Eye at the End of 12 Months.

2. Clinical Question

3. Trial Design

The study is registered as a global, randomized, phase III, double-blind, parallel-group controlled trial comparing LUBT010 with Lucentis in patients with neovascular age-related macular degeneration. The registry lists quadruple masking. These design features describe the intended comparison and blinding structure; the registry record does not specify which roles were masked or give further operational detail about concealment.

The registry lists enrollment of 600 and identifies the study status as completed. The arm-level primary outcome results are reported for 295 participants assigned to LUBT010 and 296 assigned to Lucentis. The record does not explain how these outcome analysis populations relate to enrollment or describe participant flow, withdrawals, or exclusions in detail.

The primary endpoint is mean change in BCVA from baseline in the study eye at 12 months, measured in letters. Secondary endpoints record the same type of change at 3, 6, and 9 months. The study summary describes monthly intravitreal injections. The registry also states that efficacy, safety, and immunogenicity were study objectives, but detailed immunogenicity results are not included in the listed outcome results.

The record names Lupin Ltd. as sponsor and gives the study start and primary completion dates as 2020-09-14 and 2024-05-31. It does not report the original sample-size justification, allocation ratio as a protocol specification, planned interim analyses, or the full statistical analysis plan. Those omissions limit assessment of how the completed analysis relates to the original design.

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: \[Not Specified\]

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Full Analysis Set

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: \[Not Specified\]

6. Primary Endpoint

The registry lists the primary outcome as Mean Change in BCVA From Baseline in the Study Eye at the End of 12 Months, measured over Baseline and 12 Months.

The primary endpoint measures the average change from baseline in best-corrected visual acuity in the study eye at 12 months. Visual acuity was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) charts, and the unit is letters. A change score expresses the difference between a participant’s follow-up measurement and baseline; the reported group results summarize these changes rather than the follow-up scores alone.

BCVA is a continuous measure, so the group mean provides a concise description of the average observed change. A least-squares mean is an estimate from a statistical model and may account for specified covariates or design features. The registry identifies the reported endpoint parameter as a least-squares mean, but the model terms and any covariate adjustments are not reported in the registry record.

A 12-month endpoint assesses the average result at the stated end-of-follow-up time. It does not, by itself, describe every participant’s course over time, the distribution of individual changes, or whether participants maintained a particular level of visual acuity. The registry also reports earlier mean-change endpoints, which provide context about the pattern over follow-up, but the primary endpoint remains the 12-month comparison.

7. Results Posted in the Registry

• Lucentis (Ranibizumab): mean 11.14 versus 11.17 on control; difference -0.03 (95% CI -1.93 to 1.87), standardized effect d = -0.00; z-test p = 0.975.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Mean Change in BCVA From Baseline in the Study Eye at the End of 3 Months

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Lucentis (Ranibizumab): mean 6.60 versus 7.30 on control; difference -0.70 (95% CI -2.02 to 0.62), standardized effect d = -0.09; z-test p = 0.298.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Lucentis (Ranibizumab) and the control. The interval gives the range of effects that remain compatible with the data.

Mean Change in BCVA From Baseline in the Study Eye at the End of 6 Months

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Lucentis (Ranibizumab): mean 8.70 versus 9.50 on control; difference -0.80 (95% CI -2.41 to 0.81), standardized effect d = -0.08; z-test p = 0.332.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Lucentis (Ranibizumab) and the control. The interval gives the range of effects that remain compatible with the data.

Mean Change in BCVA From Baseline in the Study Eye at the End of 9 Months

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Lucentis (Ranibizumab): mean 10.40 versus 10.60 on control; difference -0.20 (95% CI -1.97 to 1.57), standardized effect d = -0.02; z-test p = 0.825.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Lucentis (Ranibizumab) and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes use the same BCVA change measure at earlier follow-up times. Across these time points, the arm-level means are close, and the unadjusted mean-difference intervals include zero. The overall pattern is therefore broadly consistent with the primary result in showing similar average estimates between groups, while retaining uncertainty about the size and direction of the differences.

These outcomes add information about the trajectory of mean change during follow-up, but they do not replace the primary endpoint. They are separate comparisons at multiple time points, and the registry does not report whether they were designated as confirmatory, whether a hierarchy was planned, or whether multiplicity was controlled. Without that information, individual unadjusted p-values should carry less weight than a prespecified primary analysis. Repeated testing can make chance findings more likely across a collection of comparisons, even when each test is considered separately.

The secondary results are reported as ordinary means with standard deviations, whereas the primary result is reported as least-squares means with standard errors. The distinction matters: the two sets of summaries are not identical kinds of estimates or measures of variability. The unadjusted comparisons provide descriptive context, but they do not establish equivalence, and their intervals should not be interpreted using an equivalence criterion that is not reported.

Taken together, the secondary outcomes do not suggest a markedly different pattern from the primary endpoint in the posted summaries. They should be considered supportive descriptive evidence, with appropriate caution about repeated comparisons, model details, and missing-data handling. The registry record does not provide enough information to determine how these secondary findings were intended to contribute to formal conclusions.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Mean Change in BCVA From Baseline in the Study Eye at the End of 3 Months
• Mean Change in BCVA From Baseline in the Study Eye at the End of 6 Months
• Mean Change in BCVA From Baseline in the Study Eye at the End of 9 Months

9. Statistical Interpretation

10. Statistical Methods Explained

For a continuous outcome such as change in BCVA, a group mean describes the average observed change among participants included in the analysis. The primary endpoint is reported as a least-squares mean, while the secondary outcomes are reported as means. Least-squares means are model-based estimates; ordinary means summarize the observed values directly. The registry does not report enough detail about the primary model to determine how its estimates were adjusted or which assumptions were used.

What does the mean difference represent?

A mean difference is the contrast between the group estimates. Its sign depends on the order of subtraction, so a positive estimate under one ordering becomes negative if the groups are reversed. For the primary outcome, the arm-level estimates are 11.17 and 11.14 letters. The registry-reported least-squares mean difference is 0.03 letters; the unadjusted re-calculation is -0.03 when written as Lucentis minus LUBT010. The difference in sign is consistent with opposite contrast directions, and the estimates are not otherwise the same analysis: the registry reports a least-squares mean difference, whereas the re-calculation uses posted summary statistics.

How should the standard error be understood?

A standard error describes the uncertainty in an estimated group mean, rather than the spread of individual participant outcomes. Smaller standard errors generally indicate more precise estimates, while larger standard errors indicate greater sampling uncertainty. The primary arm results are reported with standard errors of 0.689 and 0.68. The secondary endpoints are reported with standard deviations instead. A standard deviation describes variation among observations, so it answers a different question from a standard error.

The re-calculated primary comparison uses an approximate standard deviation derived from the posted standard errors, as indicated by the calculation record. This makes the re-calculation a simple, unadjusted approximation, not a reproduction of the sponsor’s model. The secondary re-calculations use the posted standard deviations. Differences between these re-calculations and a model-based analysis can arise because the methods, estimands, and assumptions are not necessarily the same.

What does a confidence interval add?

A confidence interval gives a range of values compatible with the estimate under the analysis assumptions. It makes uncertainty visible in a way that a point estimate alone cannot. If an interval includes zero for a difference, the data are compatible with no average difference as well as with differences in either direction. That does not prove the groups are identical. For an equivalence question, the interval must be assessed against an equivalence margin specified in advance. The registry reports a 90% interval for its equivalence analysis, but the margin is not reported in the registry record.

The re-calculated intervals are based on summary statistics and are unadjusted. They do not incorporate any unknown covariate adjustments or other features of the sponsor’s analysis. The primary re-calculated interval is from -1.927 to 1.867. Its width indicates that the point estimate should not be interpreted without considering the range of plausible differences. The registry’s reported interval, from -1.52 to 1.58, comes from its stated least-squares mean difference analysis and should be kept distinct from the unadjusted re-calculation.

What does the p-value tell the reader?

The unadjusted primary p-value is 0.975. A p-value describes how compatible the observed result is with a specified null hypothesis under the assumptions of the test. It is not the probability that the null hypothesis is true, and it does not measure the size or clinical importance of a difference. A large p-value is not proof of equality or equivalence. For an equivalence claim, the margin and interval-based decision rule are central; the registry does not report the margin.

The secondary p-values are also unadjusted. When multiple outcomes or time points are examined, the chance of finding at least one apparently notable result can increase. Without a reported multiplicity strategy, these p-values are best treated as exploratory or descriptive rather than as a set of independent confirmatory tests. The registry does not state whether any secondary endpoint was designated as confirmatory or how multiplicity was handled.

Why can variation matter?

Variation affects how precisely a mean difference can be estimated. When outcome values vary more widely between participants, a study generally needs more information to estimate a group contrast with similar precision. This is a general statistical principle. The secondary endpoints report standard deviations, while the primary endpoint reports standard errors; the quantities should not be compared as though they represented the same kind of spread. The posted summaries do not provide the individual-level distributions needed to assess skewness, outliers, or other features of the outcome data.

Interpretation also depends on the analysis population and the handling of missing observations. The primary population is named as the Full Analysis Set, but its precise definition, missing-data procedures, and sensitivity analyses are not reported in the registry record. These details can affect an estimate, particularly if participants with unavailable measurements differ systematically from those with observed measurements. The available summary statistics alone cannot resolve that concern.

11. Confidence Intervals and Precision

The primary group estimates are 11.17 letters for LUBT010 and 11.14 letters for Lucentis. The sponsor-reported least-squares mean difference is 0.03 letters, with a 90% confidence interval from -1.52 to 1.58. The unadjusted re-calculation gives -0.03 letters, with an interval from -1.927 to 1.867. The intervals are not interchangeable: one accompanies the registry’s least-squares mean difference analysis, and the other is a simple re-calculation from posted summary statistics.

Both intervals include zero, so the reported estimates are compatible with a small difference in either direction as well as with no difference under the respective analyses. The width of an interval indicates how much uncertainty remains around the point estimate. It is therefore important not to interpret the closeness of the two arm means as proof that their underlying effects are identical.

Equivalence requires more than a non-significant difference. The interval must be compared with an equivalence margin selected before examining the results. Although the registry labels the reported analysis as equivalence, the margin is not reported in the registry record. The available information therefore allows the interval to be described, but not an independent determination of whether it met the trial’s equivalence criterion.

The secondary intervals likewise include zero at the listed follow-up times. Their precision should be considered in light of the unadjusted nature of the re-calculations and the absence of a reported multiplicity plan. Confidence intervals communicate statistical uncertainty under their assumptions; they do not address missing-data bias, model misspecification, or the clinical meaning of a particular letter difference.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are illustrative requirements in participants per arm for the continuous outcomes in this study. They are not total events: the event-based convention does not apply to these mean-change outcomes. The calculation uses a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. It sets the effect to detect at the stated fraction of the observed effect. The trial’s own original design assumptions and sample-size justification are not reported in the registry record.

The 80% power column describes the number of participants per arm that the planning calculation estimates would give an 80% chance of detecting the specified effect under its assumptions, if that effect were the true effect. The 90% power column uses a higher target chance of detection and therefore requires more participants under the same assumptions. These are planning quantities, not a description of the chance that this completed study detected a true effect.

The rows illustrate planning for 100%, 75%, and 50% of the observed effect. A smaller effect is harder to distinguish from random variation, so the calculation requires more participants to achieve the same target power. In the primary endpoint calculation, the estimated requirements are especially large because the observed unadjusted difference is very small. Such figures are highly dependent on the observed effect and should not be interpreted as the study’s original design target or as a recommendation for a future trial.

This is not observed power. Observed power calculated from the estimated effect largely restates the result and does not replace consideration of the confidence interval. The useful reading is how assumptions about the effect size and target power affect planning, not whether the completed trial was “powered” based on its observed result.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -0.030; pooled standard deviation σ = 11.767.
2. n = 2 × (1.96 + 0.842)² × 11.767² / -0.030² = 2,414,905.9, rounded up to 2,414,906 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -0.0299999999999994                      # observed difference in means
sigma <- 11.7666416003074                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(4690556)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 2,414,906 (80% power), 3,232,874 (90% power)
 75% of observed effect: n per arm = 4,293,167 (80% power), 5,747,332 (90% power)
 50% of observed effect: n per arm = 9,659,624 (80% power), 12,931,496 (90% power)
power.t.test: 2414907 
Simulated power at n = 2,414,906 per arm: 0.809 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Analyses Reported by the Sponsor

The registry reports the sponsor’s primary analysis as a least-squares mean difference of 0.03 letters, with a 90% confidence interval from -1.52 to 1.58, and classifies it as an equivalence analysis. This is the analysis to use when describing the registry’s reported primary result. The registry does not report the analysis method details or the equivalence margin, so the decision rule cannot be independently reconstructed from the entry.

The unadjusted re-calculation uses posted arm-level summary statistics and gives a difference of -0.03 letters for Lucentis minus LUBT010, with an interval from -1.927 to 1.867 and an unadjusted p-value of 0.975. The signs differ because the contrast is written in the reverse group order from the sponsor estimate. More importantly, the re-calculation is not the same model-based analysis and should not replace the sponsor’s estimate or interval.

The registry record does not flag a discrepancy between the posted primary result and the re-calculation. Even so, the calculations answer slightly different statistical questions and rely on different information. The sponsor’s reported analysis takes precedence for describing the trial’s own stated result; the re-calculation is supplementary context about the posted summaries, not an independent validation of the analysis or of the equivalence claim.

15. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary endpoint and three secondary BCVA change outcomes at different follow-up times. It reports one primary analysis and does not provide secondary reported analyses in the registry entry. The re-calculated secondary comparisons are unadjusted. The statistical plan for handling the family of outcomes, including whether any hierarchy or multiplicity adjustment was prespecified, is not reported in the registry record.

Multiplicity matters because each additional statistical comparison creates another opportunity for a chance result to appear notable. This is a general statistical concern, not evidence that any particular result in this study is false. Without knowing the prespecified testing strategy, secondary p-values should be interpreted cautiously and should not be treated as independent confirmation of the primary result.

The primary population is identified as the Full Analysis Set. The precise membership criteria, the number of participants with an observed primary measurement, and the treatment of participants with missing outcomes are not reported in the registry record. Missing-data methods can influence estimates if the availability of measurements is related to outcomes or treatment. The registry entry does not describe imputation, model-based handling of missing observations, sensitivity analyses, or reasons for missingness.

The record also does not report the detailed statistical model, covariates, handling of protocol deviations, or the original sample-size justification. It does not state whether interim analyses were planned or conducted. These omissions limit assessment of whether the reported analysis follows a prespecified plan and how robust the primary and secondary results are to alternative reasonable assumptions. They should be treated as unknowns rather than filled in by assumptions about common trial practice.

For the equivalence interpretation, the missing prespecified margin is particularly important. The registry labels the result as equivalence and gives a 90% interval, but does not report the boundary within which the interval would need to fall. The record therefore supports reporting the sponsor’s classification and numerical interval, but not independently verifying the equivalence decision rule.

16. 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 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: myocardial infarction (0.7%), syncope (0.7%), iron deficiency anaemia (0.3%), atrial fibrillation (0.3%), atrioventricular block complete (0.3%).

The registry lists serious adverse events for 26 participants in the LUBT010 group, with 299 at risk, and 23 participants in the Lucentis group, with 301 at risk. Other adverse events are listed for 21 and 26 participants, respectively, with the same group-specific at-risk denominators. Deaths are reported as 3 and 4, respectively. These are counts in the posted safety summary, not estimates adjusted for exposure time or differences in follow-up.

The registry also lists serious adverse event terms and percentages, including myocardial infarction and syncope at 0.7% each, and iron deficiency anaemia, atrial fibrillation, atrioventricular block complete, and cardiac failure acute at 0.3% each. These entries describe reported terms; the registry summary does not provide enough detail to establish causality or to compare the full clinical context of events across groups.

Adverse-event counts alone do not establish that one treatment is safer. Definitions, event ascertainment, exposure duration, severity, relatedness assessments, and missing safety information are not reported in the registry record. The figures should be read as a descriptive safety summary rather than as a complete comparative safety analysis.

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

The registry results show close average BCVA change estimates between the LUBT010 and Lucentis groups at the primary follow-up time. The sponsor reports a least-squares mean difference of 0.03 letters and labels the analysis as equivalence. The interval reported for that analysis spans values on either side of zero, while the registry does not state the equivalence margin needed to independently assess the claim.

This does not mean that the treatments have been shown to be identical in every respect or for every participant. Group means summarize averages and can conceal variation in individual outcomes. The confidence interval describes uncertainty in a group contrast under the analysis assumptions; it does not eliminate uncertainty about model choices, missing outcomes, or the applicability of the result beyond the study population.

The unadjusted p-value does not answer whether the treatments are equivalent. A failure to find evidence of a difference is not the same as demonstrating that any difference is small enough to meet a prespecified equivalence criterion. The registry’s equivalence label is part of its reported result, but the missing margin and analysis details prevent a complete independent evaluation.

The secondary outcomes show a broadly similar pattern in the posted summaries, but multiple unadjusted comparisons carry less confirmatory weight. Safety counts are descriptive and do not establish comparative safety. The registry record also does not provide detailed immunogenicity findings, participant flow, missing-data analyses, or full protocol context.

Accordingly, the result supports a careful description of the reported estimates and their uncertainty. It does not, on its own, justify a broader claim about all relevant outcomes, long-term effects, or every clinical setting. Clinical decisions require consideration of the full evidence and patient-specific circumstances; the registry summary is a statistical account of one trial rather than individualized medical guidance.

18. Why This Trial Matters Statistically

This trial matters statistically because it frames the comparison as an equivalence question, not simply as a search for evidence of a difference. Those questions require different reasoning. A conventional non-significant comparison does not establish equivalence; the interval must be judged against a margin specified in advance. The registry reports an equivalence analysis and its interval, but the margin is not reported, leaving an important part of that interpretation unavailable.

The contrast between the sponsor’s least-squares mean analysis and the unadjusted summary-statistic re-calculation also illustrates why estimates should be interpreted with their method and estimand in view. Similar point estimates do not make analyses interchangeable. The sponsor’s result is the trial’s reported analysis, while the re-calculation offers a limited, unadjusted check using summary data.

The primary and secondary outcomes also highlight how time points and repeated comparisons affect interpretation. The earlier mean-change results broadly resemble the primary pattern, but unadjusted secondary tests should not be treated as independent confirmation without a reported multiplicity strategy. Safety counts likewise need context beyond raw group counts.

Finally, the record’s missing information—especially the equivalence margin, analysis details, missing-data approach, and original sample-size justification—shows why transparent reporting is central to statistical appraisal. The posted estimates can be described precisely, but the strength of conclusions depends on design and analysis details that are not available in the registry record.

19. 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 primary endpoint is reported as a least-squares mean, but the registry does not describe the model, its covariates, or the estimation procedure. The equivalence margin is also absent. This limits independent evaluation of whether the reported 90% interval satisfies the trial’s intended equivalence criterion.

The registry lists the Full Analysis Set as the primary population but does not define its membership or provide detailed participant flow. The number and characteristics of participants with missing outcome measurements, reasons for missingness, and methods for handling missing data are not reported in the registry record. Without these details, it is not possible to assess potential bias from incomplete follow-up or to determine how sensitive the estimates are to alternative assumptions.

The re-calculated primary comparison is approximate and unadjusted, based on posted summary statistics rather than participant-level data or the sponsor’s model. The primary arm summaries give standard errors, and the re-calculation uses an approximate standard deviation. Thus, the re-calculation should not be used as a replacement for the registry-reported analysis.

The registry does not report the original sample-size rationale, planned interim analyses, or a multiplicity strategy for the secondary endpoints. The displayed planning illustrations are based on observed effects and are not evidence of the trial’s initial design assumptions. The listed safety results lack detail about event definitions, exposure duration, relatedness, and ascertainment. Detailed immunogenicity results are not included among the posted outcomes. These limitations constrain interpretation beyond the reported mean changes and descriptive safety counts.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Study to Compare Efficacy, Safety, and Immunogenicity of LUBT010 (Proposed Ranibizumab Biosimilar) and Lucentis® in Patients With Neovascular AMD — NCT04690556.
• Registry record last updated 2026-01-29; status last verified 2026-01.
• Results first posted 2026-01-06.
• 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.

23. Record Summary

The registry record describes a completed global, randomized, quadruple-masked, parallel-group phase III trial sponsored by Lupin Ltd. It compares LUBT010, a proposed ranibizumab biosimilar, with Lucentis in patients with neovascular age-related macular degeneration. Listed enrollment is 600.

The primary outcome is mean change in BCVA from baseline in the study eye at 12 months, measured in ETDRS letters. The registry reports a least-squares mean difference of 0.03 letters and a 90% confidence interval from -1.52 to 1.58, with the analysis classified as equivalence. The equivalence margin and detailed analysis plan are not reported in the registry record.

The posted secondary mean-change outcomes at earlier follow-up times show a broadly similar pattern in the two groups. Safety information is reported as adverse-event and death counts. The registry does not provide detailed missing-data methods, multiplicity procedures, or full analysis-population definitions.