Study to Evaluate the Efficacy and Safety of Filgotinib in Adults With Active Noninfectious Uveitis: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Study to Evaluate the Efficacy and Safety of Filgotinib in Adults With Active Noninfectious Uveitis (NCT03207815), a randomized phase 2 study. The primary outcome is Percentage of Participants Failing Treatment for Active NonInfectious Uveitis by Week 24.

2. Clinical Question

The primary outcome counted a participant as having treatment failure if at least one qualifying event occurred in at least one eye. Criteria covered new active inflammatory lesions; specified worsening or failure to reach a target in anterior chamber cell grade or vitreous haze; and worsening of best corrected visual acuity by at least 15 letters from the best state achieved. The registry’s definitions use standardized grading criteria for the eye findings.

The comparison is between two groups receiving the same prednisone regimen, with filgotinib or matching placebo added. It therefore concerns the difference between those study regimens, not filgotinib in isolation. The registry record does not report the reason the study was terminated or the original assumptions used to plan its size.

3. Trial Design

This was a randomized, double-blind, parallel-group, placebo-controlled Phase 2 trial sponsored by Gilead Sciences. The registry reports enrollment of 74 participants, a start date of 2017-07-26, primary completion on 2020-12-29, and a status of terminated. The reason for termination is not reported in the registry record.

Participants were assigned to filgotinib or matching placebo. Both groups also received a standardized prednisone burst of 60 mg/day at Day 1/Baseline followed by a mandatory taper schedule up to Week 15. Filgotinib or matching placebo was intended once daily for up to 52 weeks. The primary endpoint covered treatment failure from Week 6 through Week 24, while the listed secondary time-to-event outcomes cover Week 6 through Week 52.

The primary analysis population was narrower than everyone enrolled: it included randomized participants who received at least one dose and did not permanently discontinue from the study before Week 6. The posted primary results include 32 participants in the filgotinib group and 34 in the placebo group. Safety results use different group counts, which are described separately with those findings.

The registry lists additional secondary outcomes involving eye inflammation grades, visual acuity, central retinal thickness, macular edema, and plasma concentrations. It does not report the original sample-size justification, the full statistical analysis plan, or an explanation for termination. The registry record also does not report whether interim analyses were planned or conducted.

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: 116 participants were screened.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Evaluable Analysis Set included all randomized participants who received at least one dose of study drug and did not permanently discontinue from the study prior to Week 6.

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: Safety Analysis Set included all participants who received at least 1 dose of study drug.

6. Primary Endpoint

The registry lists the primary outcome as Percentage of Participants Failing Treatment for Active NonInfectious Uveitis by Week 24, measured over Week 6 through Week 24.

The primary endpoint was the percentage of participants who failed treatment for active noninfectious uveitis between Week 6 and Week 24. It turns several kinds of worsening in either eye into a participant-level binary outcome: a participant either met at least one failure criterion or did not. A participant could qualify through new inflammatory lesions, changes in anterior chamber cell grade or vitreous haze, or deterioration in best corrected visual acuity.

This kind of composite endpoint can capture more than one clinically relevant manifestation of the disease in a single summary. It also means that the overall percentage does not reveal which specific criterion accounted for each failure. The registry’s criteria compare eye findings with baseline or the best state achieved, depending on the finding and visit. Higher anterior chamber cell and vitreous haze grades indicate more severe uveitis in the definitions.

The analysis population excluded participants who permanently discontinued before Week 6, and the outcome window began at Week 6. This defines the population and period to which the posted primary percentages apply; the registry record does not establish how those findings generalize beyond that group or timeframe.

7. Results Posted in the Registry

• Filgotinib: 37.5% (12/32) versus 67.6% (23/34) on control; risk difference -30.1 percentage points (95% CI -53.1 to -7.2), risk ratio 0.55 (0.33–0.92); unadjusted two-proportion z-test p = 0.014.

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.

Time to Treatment Failure on or After Week 6

• Endpoint type: Time to event: compared as a hazard ratio.
• Test: Hazard ratio as reported by the sponsor (Stratified Log-Rank Test); it was not recalculated.
• Result:
  • Filgotinib vs Placebo: hazard ratio 0.31 (95% CI 0.14–0.66), reported p = 0.001 (as reported in the registry).
• Interpretation:
  • The 95% confidence interval excludes no difference (a ratio of 1), so the hazard of the event is statistically lower for Filgotinib vs Placebo than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Time to Development of Macular Edema in At Least One Eye on or After Week 6

• Endpoint type: Time to event: compared as a hazard ratio.
• Test: Hazard ratio as reported by the sponsor (Stratified Log-Rank Test); it was not recalculated.
• Result:
  • Filgotinib vs Placebo: hazard ratio 1.19 (95% CI 0.62–2.28), reported p = 0.589 (as reported in the registry).
• Interpretation:
  • The 95% confidence interval includes no difference (a ratio of 1), so these data do not show a statistically significant difference between Filgotinib vs Placebo and the control. The interval gives the range of effects that remain compatible with the data.

The registry lists secondary outcomes covering time to treatment failure, eye inflammation grades, visual acuity, retinal thickness, macular edema, and plasma concentrations. Numerical comparative results are available in the record for time to treatment failure and time to macular edema. Numeric findings for the other listed secondary measures are not reported in the registry record.

The treatment-failure time-to-event result is directionally consistent with the primary Week 24 comparison: its reported hazard ratio is below 1, and its 95% confidence interval is also below 1. The macular-edema estimate is less conclusive: its interval spans 1, leaving uncertainty about the relative event hazard. These are distinct outcomes and analyses, so neither should be treated as a direct confirmation or contradiction of the primary endpoint.

Secondary results generally carry less evidential weight when many outcomes are examined and no multiplicity procedure is reported. With multiple comparisons, the chance of obtaining a nominally notable result by chance can increase. The registry does not report a multiplicity adjustment or a hierarchy for interpreting the secondary outcomes. The posted secondary findings are therefore best read as outcome-specific evidence, with attention to their intervals and methods, rather than as a collection of independent confirmations.

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

• Time to Treatment Failure on or After Week 6
• Change in Vitreous Haze (VH) Grade in Each Eye (NEI/SUN Criteria), From Best State Achieved Prior to Week 6 to Week 52 or End of Treatment (EOT) Visit or Early Termination (ET)
• Change in Anterior Chamber (AC) Cell Grade in Each Eye, From Best State Achieved Prior to Week 6 to Week 52 or EOT Visit or ET
• Change in Logarithm of the Minimal Angle of Resolution (logMAR) Best Corrected Visual Acuity (BCVA) in Each Eye, From Best State Achieved Prior to Week 6 to Week 52 or EOT Visit or ET
• Log Change in Central Retinal Thickness in Each Eye, From Best State Achieved Prior to Week 6 to Week 52 or EOT Visit or ET
• Time to Development of Macular Edema in At Least One Eye on or After Week 6
• Plasma Concentration of Filgotinib
• Plasma Concentration of Metabolite, GS-829845

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is binary at the participant level: treatment failure occurred or did not occur by the stated time. A percentage is an estimate of the proportion of participants with the event in each group. The posted estimates are 37.5% for filgotinib and 67.6% for placebo. The confidence intervals express uncertainty around each group’s estimated percentage; they are not ranges containing a known fixed percentage with certainty.

What does the risk difference represent?

A risk difference compares the event proportions by subtraction, with the sign depending on the order of the groups. A negative estimate in this comparison indicates a lower failure percentage in the filgotinib group than in the placebo group. The sponsor reported a difference of -30.1 percentage points. Its 95% confidence interval, -56.2 to -4.1, excludes zero. The sponsor’s p-value was 0.006. A p-value describes how compatible the observed data are with a null hypothesis under the assumptions of the analysis; it is not the probability that the null hypothesis is true, nor does it measure clinical importance.

Why are the sponsor analysis and recalculation different?

The registry’s reported primary analysis used the Cochran-Mantel-Haenszel method to compare treatment failure rates. The simple recalculation uses the posted event counts and group sizes without reproducing that method. Such a recalculation is useful as a check of the direction and rough scale of the result, but it need not match an analysis using a different procedure. The sponsor’s reported result is the registry’s own analysis. The record does not provide details of any stratification factors or the full statistical analysis plan.

How should a hazard ratio be read?

A hazard ratio compares the event rates over time between groups, subject to the time-to-event model and its assumptions. A value below 1 means the estimated event hazard is lower in the first-named group relative to the comparator; a value above 1 means it is higher. The time-to-treatment-failure estimate was 0.309, with a 95% confidence interval from 0.144 to 0.663. The macular-edema estimate was 1.193, with a 95% confidence interval from 0.625 to 2.277. A hazard ratio is not a ratio of the percentages with events at a single timepoint, and it does not directly state how many weeks separate events.

The registry reports the stratified log-rank test for each secondary time-to-event comparison. It reports a median of 22.0 weeks for placebo in the treatment-failure analysis, but no median value for filgotinib. A missing median in the record should not be interpreted as a specific event time; the registry record does not report a median for that group. For macular edema, the listed median values are 7.8 weeks for filgotinib and 12.3 weeks for placebo, but the hazard ratio and its interval are the reported comparative analysis. Median times and hazard ratios summarize different aspects of event timing.

Why does over-dispersion matter in general?

General statistical explanation: over-dispersion occurs when observed variability is greater than a statistical model expects. If a model assumes less variability than the data contain, standard errors may be too small and confidence intervals may be too narrow. The primary endpoint is a binary participant-level outcome, and the registry does not report an over-dispersion adjustment. The concept is relevant to count or rate models, but the record does not identify such a model for the primary endpoint.

What do the confidence intervals and tests add?

A confidence interval communicates both the estimate and its statistical precision. A narrower interval indicates greater precision under the analysis assumptions; a wider interval indicates that a broader range of values remains compatible with the data. The primary sponsor interval excludes zero, while the macular-edema hazard-ratio interval includes 1. For a difference, zero represents no difference; for a ratio, 1 represents no relative difference. These reference values help interpret the interval but do not replace consideration of study design, analysis population, and the range of effects that may matter.

The registry does not report whether adjustments were made for examining multiple endpoints, whether interim analyses occurred, or how missing observations were handled. Such information can affect interpretation of p-values, confidence intervals, and time-to-event estimates. The record’s stated analysis methods therefore support a description of the posted results, but not a complete reconstruction of every statistical decision.

11. Confidence Intervals and Precision

The primary group estimates have 95% confidence intervals of 19.2% to 55.8% for filgotinib and 50.5% to 84.8% for placebo. These intervals are broad relative to the point estimates, so the exact failure percentage in either group remains uncertain. The sponsor’s difference interval, -56.2 to -4.1 percentage points, spans effects of different magnitudes while remaining below zero. It supports a lower estimated failure rate in the filgotinib group in this analysis, but does not identify a single precise effect size.

The time-to-treatment-failure hazard ratio of 0.309 has a 95% confidence interval from 0.144 to 0.663. This interval is below 1, but includes a range of relative hazard estimates. The macular-edema hazard ratio of 1.193 has a 95% confidence interval from 0.625 to 2.277, spanning values below and above 1. It therefore leaves substantial uncertainty about the comparative direction and magnitude for that endpoint.

Confidence intervals reflect sampling uncertainty under the relevant analysis assumptions. They do not account for every possible source of uncertainty, such as limitations in trial conduct or unreported analytical choices. The group sizes in the primary analysis were 32 and 34, and the registry status is terminated. Those features are important context for the precision and scope of the estimates.

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 sample-size figures are planning illustrations based on observed effects, not the trial’s original design justification. For the primary binary outcome, the entries are participants per arm. Planning for 100% of the observed effect gives 42 participants per arm for 80% power and 56 per arm for 90% power. Planning for 75% of the observed effect gives 75 per arm for 80% power and 100 per arm for 90% power. Planning for 50% of the observed effect gives 165 per arm for 80% power and 220 per arm for 90% power.

For the time-to-treatment-failure illustration, the entries are total events rather than participants per arm. Planning for 100% of the observed effect gives 23 total events for 80% power and 31 for 90% power; for 75% of the observed effect, 41 and 55 total events; and for 50% of the observed effect, 92 and 122 total events. For macular edema, the corresponding total-event figures are 1,009 and 1,350; 1,793 and 2,400; and 4,033 and 5,399.

The assumptions listed for these illustrations are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The time-to-event calculations use the Schoenfeld method. The 80% and 90% columns describe the probability of detecting the specified effect under those planning assumptions if that effect is real. Smaller effects require more participants or events to detect with the same power. These figures are not observed power.

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, p₀ and p₁ are the control and treatment proportions, and p̄ is their average.

Worked calculation for this trial

1. Control proportion p₀ = 0.676; treatment proportion p₁ = 0.375; average p̄ = 0.526.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.7062 = 1.3841.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.6732 = 0.5666.
4. n = (1.3841 + 0.5666)² / (-0.3015)² = 41.9, rounded up to 42 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
p0 <- 0.676470588235294                          # control proportion
p1 <- 0.375                          # treatment proportion
n_per_arm <- function(power, frac = 1) {
  q1 <- p0 + (p1 - p0) * frac               # smaller effect = fraction of the observed difference
  pbar <- (p0 + q1) / 2
  z_b <- qnorm(power)
  ceiling(round((z_a * sqrt(2 * pbar * (1 - pbar)) + z_b * sqrt(p0 * (1 - p0) + q1 * (1 - q1)))^2 / (q1 - p0)^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 (unrounded n per arm)
cat("power.prop.test:", round(power.prop.test(p1 = p0, p2 = p1, power = 0.80)$n, 1), "\n")

# Simulation: how often does the z-test reject at the 80%-power sample size?
set.seed(3207815)
n    <- n_per_arm(0.80)
reps <- 20000
x0 <- rbinom(reps, n, p0); x1 <- rbinom(reps, n, p1)
ph <- (x0 + x1) / (2 * n)
z  <- ((x1 - x0) / n) / sqrt(ph * (1 - ph) * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(z) > z_a, na.rm = TRUE), reps))

Output from running the code

100% of observed effect: n per arm = 42 (80% power), 56 (90% power)
 75% of observed effect: n per arm = 75 (80% power), 100 (90% power)
 50% of observed effect: n per arm = 165 (80% power), 220 (90% power)
power.prop.test: 41.9 
Simulated power at n = 42 per arm: 0.830 (20000 replicates)

The simulation draws many pairs of event counts at the planned sample size and counts how often the two-proportion z-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 sponsor’s primary analysis reports a difference in treatment failure rate of -30.1 percentage points, with a 95% confidence interval from -56.2 to -4.1 and p = 0.006. It uses the Cochran-Mantel-Haenszel method. The posted group percentages are 37.5% for filgotinib and 67.6% for placebo.

The simple recalculation from the posted counts and group sizes is unadjusted and does not reproduce the sponsor’s method. It points in the same direction, while the methods can yield different estimates, intervals, and p-values. The registry marks the discrepancy flag as false. The sponsor’s analysis is therefore not in conflict with the recalculation according to the record, but the two should not be presented as identical analyses.

The record does not describe the strata used in the sponsor analysis or provide a full analysis plan. The sponsor result is the reported trial analysis, while the recalculation is a supplementary, unadjusted check based on the posted summary statistics.

15. Multiplicity, Missing Data and Analysis Populations

The registry lists multiple secondary outcomes alongside the primary endpoint. It does not report a procedure for adjusting statistical tests or confidence intervals for multiplicity, a hierarchy for testing endpoints, or whether particular secondary analyses were designated confirmatory. Without that information, the nominal p-values for secondary outcomes should be interpreted cautiously: testing many outcomes can increase the chance of at least one apparently notable result even when no corresponding effect exists.

The primary analysis population is explicitly defined as randomized participants who received at least one dose and did not permanently discontinue before Week 6. The primary group counts were 32 for filgotinib and 34 for placebo. The record does not report the number excluded before Week 6, the reasons for exclusion, or whether missing primary outcome assessments occurred. It also does not describe an imputation method or sensitivity analyses for missing data.

For time-to-event analyses, the registry reports stratified log-rank methods and hazard ratios, but does not describe censoring rules, missing follow-up handling, or additional model diagnostics. The safety group counts differ from the primary analysis counts; the record does not explain the difference. The original sample-size justification and the trial’s own planned power are not reported in the registry record. Interim analyses and their handling, if any, are also not reported in the registry record.

These omissions do not change the posted estimates, but they limit the ability to assess how robust the analyses are to unreported choices about populations, missing observations, multiplicity, and follow-up.

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: retinal vasculitis (2.9%), urinary tract infection (2.9%), uveitis (2.7%), inflammatory bowel disease (2.7%), covid-19 (2.7%).

In the safety groups, 5 of 37 participants in the filgotinib group and 2 of 35 in the placebo group were reported as affected by a serious adverse event. Other adverse events affected 28 of 37 and 19 of 35 participants, respectively. No deaths were reported in either group.

The registry lists serious-event terms including retinal vasculitis and urinary tract infection at 2.9% each, and uveitis, inflammatory bowel disease, Covid-19, and spinal stenosis at 2.7% each. These are the terms and percentages listed in the record; they do not by themselves establish that an event was caused by study treatment.

These are descriptive counts from the safety groups, which have different denominators from the primary efficacy analysis. The registry record does not provide enough detail in these figures to assess event timing, duration, severity beyond the serious-event classification, or individual attribution. The counts should be read as reported safety observations rather than as a causal comparison.

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

The primary result describes a lower observed percentage of treatment failure by Week 24 in the filgotinib group than in the placebo group, among participants in the defined Evaluable Analysis Set. The sponsor’s reported difference and confidence interval quantify that comparison under the registry’s stated method. The time-to-treatment-failure analysis also reports a hazard ratio below 1. Together, these results describe a pattern within this trial, not a guarantee of the same result elsewhere.

The primary endpoint combines several ways of meeting treatment-failure criteria. Its overall percentage does not show how many participants failed through each individual eye finding, nor does it establish how each component changed. The results also apply to the regimens studied: both groups received prednisone, with filgotinib or matching placebo added. They are not a comparison of filgotinib alone against no treatment.

The macular-edema estimate is uncertain, with a confidence interval spanning values below and above the no-difference reference for a hazard ratio. The record does not report numeric results for several other listed secondary outcomes. The evidence therefore does not support broad conclusions across every measure of eye inflammation, vision, retinal thickness, or drug concentration.

The trial enrolled 74 participants and is listed as terminated. The reason for termination is not reported in the registry record. Its findings do not establish how results would vary in other populations or settings, and they do not answer questions beyond the outcomes, participants, and follow-up described in the record. No individual treatment decision follows from these group-level statistical results.

18. Why This Trial Matters Statistically

This trial illustrates why the analysis population and endpoint definition matter. The enrolled total was 74, but the primary result applies to participants who met the registry’s post-randomization criteria, with 32 in the filgotinib group and 34 in the placebo group. The endpoint is a participant-level composite that can be triggered by several kinds of changes in either eye. Readers need both details to understand what the percentages represent.

It also shows how distinct methods can answer related but different questions. The primary comparison is a difference in treatment-failure percentages by Week 24, while the secondary treatment-failure analysis compares event timing across follow-up. A hazard ratio is not interchangeable with a percentage difference at a fixed time. The registry’s sponsor analysis and an unadjusted recalculation likewise use different procedures, even though their direction is consistent.

Finally, the confidence intervals and unreported analysis details are central to interpretation. The primary estimate has uncertainty about its exact size, and the macular-edema estimate is compatible with relative hazards on either side of 1. The record does not report multiplicity handling, missing-data methods, the original sample-size justification, or the reason for termination. These gaps demonstrate why statistical significance alone cannot summarize the strength, scope, or limits of trial evidence.

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.
• Participant counts were reconstructed from posted percentages and arm sizes, so small rounding differences are possible.

The registry lists the trial as terminated but does not report why. This limits interpretation of the trial’s completion and the context for the available results. Enrollment was 74, and the primary analysis used a smaller defined population, with 32 participants in the filgotinib group and 34 in the placebo group. The record does not explain the difference between the enrolled total and the primary analysis group counts.

The primary outcome is a composite: any of several specified findings in at least one eye can qualify as treatment failure. The posted overall percentages do not separate the contribution of each criterion. The primary window ends at Week 24, while the listed follow-up for time-to-event outcomes extends through Week 52; these results address different time periods and estimands.

The registry does not report the original sample-size justification, missing-data procedures, multiplicity adjustment, interim-analysis plan, or full statistical analysis plan. It also does not report numerical findings for several listed secondary outcomes. Safety group counts differ from the primary efficacy counts, and the record does not explain why. These limitations restrict assessment of analysis robustness and the breadth of conclusions that can be drawn from the posted results.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Study to Evaluate the Efficacy and Safety of Filgotinib in Adults With Active Noninfectious Uveitis — NCT03207815.
• Registry record last updated 2022-01-21; status last verified 2021-12.
• Results first posted 2022-01-21.
• 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

NCT03207815 was a randomized, double-blind, parallel-group, placebo-controlled Phase 2 trial of filgotinib in adults with active noninfectious uveitis. Both groups received a standardized prednisone burst and taper. The registry reports enrollment of 74, primary completion on 2020-12-29, and terminated status.

The primary endpoint was treatment failure between Week 6 and Week 24. The reported percentages were 37.5% for filgotinib and 67.6% for placebo; the sponsor reported a difference of -30.1 percentage points, with a 95% confidence interval from -56.2 to -4.1 and p = 0.006. Secondary time-to-event analyses reported a hazard ratio of 0.309 for treatment failure and 1.193 for macular edema. The reason for termination and several analysis-plan details are not reported in the registry record.