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 Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal Insert (NCT01694186), a randomized phase 3 study. The primary outcome is Proportion of Subjects With Recurrence of Uveitis in the Study Eye and Overall Summary of Number of Participants With Ocular Treatment-Emergent Adverse Events for the Study Eye Through Month 36 Visit.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01694186 |
| Phase | Phase 3 |
| Condition | Non-Infectious Uveitis |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 129 |
| Arms in the primary outcome | n/a |
| Lead sponsor | EyePoint Pharmaceuticals, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Subjects with chronic non-infectious uveitis affecting the posterior segment of the eye. The primary outcome description refers to recurrence in the study eye; the record also identifies an ITT population for recurrence and a Safety Population for ocular adverse events.
Intervention
FAI insert, described in the arm information as an insert containing 0.18 mg fluocinolone acetonide.
Comparator
Sham injection.
Primary question
Whether uveitis recurred in the study eye after study treatment, alongside assessment of ocular treatment-emergent adverse events. The efficacy description refers to recurrence within 6 months after treatment, while the outcome title and population description also refer to recurrence at 36 months. The registry record does not resolve this difference or report a single numerical treatment comparison.
In statistical terms, the efficacy question concerns a binary outcome: whether a participant had a recurrence during the specified period. Such outcomes are commonly summarized by the number or proportion of participants with an event in each group, with an estimate of the between-group difference or another defined contrast. The registry record does not include those group-specific recurrence counts, an effect estimate, or an uncertainty interval, so the size and precision of any efficacy contrast cannot be described from this record.
The safety question is separate. The endpoint description lists ocular adverse events and events related to elevated intraocular pressure, cataract, clinically significant ocular changes, and procedures. The record gives some serious and other adverse-event counts, but those figures do not substitute for the missing recurrence comparison. They should be interpreted as safety summaries, not as evidence that one intervention is preferable.
3. Trial Design
The registry describes a Phase III, multinational, multicenter, randomized, masked, controlled study using a parallel design. Its masking field specifies double masking. Participants were assigned to the FAI insert or sham injection arms, and the record lists an enrollment of 129. The record identifies EyePoint Pharmaceuticals, Inc. as the sponsor and gives the study status as completed.
The study start date is 2013-08-02, and the primary completion date is 2018-03-26. These are registry dates; they do not, by themselves, describe the timing of individual participants’ follow-up or indicate when each outcome was assessed. The primary endpoint information refers to a 36-month timeframe for the overall ocular treatment-emergent adverse-event summary. Its efficacy description, however, says recurrence was assessed within 6 months after treatment, while the title and population description also refer to recurrence at 36 months. The registry record does not explain how these time references fit together.
Randomization is intended to support a fair comparison by assigning participants to groups according to a chance-based process. Masking is intended to limit the influence of knowledge about assignment on care, outcome assessment, or reporting. A parallel design means the assigned groups are compared over the study rather than participants crossing between the interventions. These are general features of the design; the registry record does not report the precise randomization procedure, which people were masked, or the operational details of masking.
The record lists two interventions: FAI insert and sham injection. It describes the FAI insert as containing 0.18 mg fluocinolone acetonide and identifies the comparator as sham injection. It does not report further administration details, eligibility criteria beyond the broad disease description, or a full account of permitted co-interventions. Those details should not be inferred from the intervention names alone.
The registry lists one outcome measure and zero analyses. The primary outcome combines a recurrence endpoint with a summary of ocular treatment-emergent adverse events, but the record does not supply the detailed analysis results needed to establish how the efficacy groups compared. The overall design can therefore be described, while the trial’s primary efficacy finding cannot be reconstructed from 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 | Sham Injection | FAI Insert |
|---|---|---|
| STARTED | 42 | 87 |
| COMPLETED | 36 | 80 |
| NOT COMPLETED | 6 | 7 |
Analysis population for the primary outcome, as defined in the registry: Proportion of Subjects with Recurrence of Uveitis in the Study Eye at 36 Months (ITT Population) Overall Summary of Ocular Treatment-Emergent Adverse Events for the Study Eye Through Month 36 Visit (Safety Population)
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: A total of 129 (100%) subjects were included in the ITT and safety populations. 87 subjects in the FAI Insert 42 subjects in the Sham Injection
| Characteristic | Unit | Sham Injection | FAI Insert | Total |
|---|---|---|---|---|
| Participants analysed | 42 | 87 | 129 | |
| Age, Continuous | years | 48.3 (SD 13.71) | 48.3 (SD 13.90) | 48.3 (SD 13.79) |
| Sex: Female, Male: Female | Participants | 29 | 50 | 79 |
| Sex: Female, Male: Male | Participants | 13 | 37 | 50 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 12 | 21 | 33 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 3 | 4 | 7 |
| Race (NIH/OMB): White | Participants | 26 | 60 | 86 |
| Race (NIH/OMB): More than one race | Participants | 1 | 2 | 3 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: Hungary | participants | 1 | 0 | 1 |
| Region of Enrollment: United States | participants | 19 | 37 | 56 |
| Region of Enrollment: United Kingdom | participants | 4 | 16 | 20 |
| Region of Enrollment: Israel | participants | 4 | 6 | 10 |
| Region of Enrollment: Germany | participants | 3 | 8 | 11 |
| Region of Enrollment: India | participants | 11 | 20 | 31 |
| ITT and Safety populations: ITT | Participants | 42 | 87 | 129 |
| ITT and Safety populations: Safety | Participants | 42 | 87 | 129 |
6. Primary Endpoint
The registry lists the primary outcome as Proportion of Subjects With Recurrence of Uveitis in the Study Eye and Overall Summary of Number of Participants With Ocular Treatment-Emergent Adverse Events for the Study Eye Through Month 36 Visit, measured over 36 months.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary outcome description brings together two kinds of information. Its efficacy component is the proportion of subjects with recurrence of uveitis in the study eye. The description says recurrence within 6 months after receiving study treatment; the outcome title and population wording also refer to recurrence at 36 months. This discrepancy in time references is not resolved in the registry record.
A recurrence endpoint is clinically interpretable as an event occurring or not occurring for each participant during a defined period. Comparing the proportion with recurrence between randomized groups can address whether the observed event frequency differed under the study conditions. A defined assessment window matters: participants need to be evaluated over a comparable period, and the handling of events outside that window must be clear. The record does not provide the group-specific recurrence counts, the statistical contrast, or enough detail to establish how the time references were applied.
The other component is an overall summary of ocular treatment-emergent adverse events for the study eye through the Month 36 visit. The description lists ocular events including elevated intraocular pressure, related medications or procedures, cataract development or worsening, cataract procedures, clinically significant ocular changes, and procedure-related adverse events. These safety outcomes complement the efficacy question but are not themselves a recurrence comparison.
The registry record does not report a single numerical primary efficacy result. As a result, it is not possible to describe the magnitude or precision of the recurrence contrast from this record. Nor should the safety summaries be treated as a substitute for the efficacy endpoint. A clear interpretation requires knowing the outcome definition, assessment window, analysis population, group-specific event data, and the method used to compare groups.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies randomized groups, a primary recurrence question, and safety outcomes, but it does not report the numerical results for the primary efficacy comparison. It lists one outcome measure and zero analyses. The recurrence counts by group, an effect estimate, a confidence interval, and a p-value are not reported in the registry record. Consequently, the size, direction, and precision of the primary efficacy contrast cannot be assessed from the information in this record.
There is also an unresolved difference in how the recurrence period is described. The primary efficacy description refers to recurrence within 6 months after treatment, whereas the outcome title and population wording refer to recurrence at 36 months. These time references could represent different ways of describing follow-up, but the registry record does not explain their relationship. They should not be silently treated as equivalent. For a binary event outcome, the assessment window determines which events count and which participants are considered at risk for the event.
The record does provide safety counts. For serious adverse events, the Sham Injection group lists 17 affected participants among 42 at risk, and the FAI Insert group lists 29 among 87 at risk. For other adverse events, the listed counts are 40 among 42 and 84 among 87, respectively. Deaths are listed as 0 for Sham Injection and 1 for FAI Insert. These are descriptive registry figures. The record does not give an adjusted comparison or uncertainty interval for them, so they should not be interpreted as precise estimates of differences between groups.
The listed serious adverse-event terms include Uveitis at 9.5%, Cataract at 8.0%, Macular oedema at 4.8%, Non-infectious endophthalmitis at 4.8%, Angina pectoris at 2.4%, and Diarrhoea at 2.4%. The record does not specify in the listed information whether these term percentages are presented by arm or provide the denominator details for each term. They therefore cannot be used to infer arm-specific risks or to rank comparative safety.
General statistical interpretation distinguishes the observed data from the uncertainty around an estimate. A confidence interval describes a range of values compatible with the data and analysis assumptions; it is not reported for the primary comparison in this record. A p-value, if reported, would address compatibility with a specified null hypothesis under the analysis model, not the clinical importance of an effect. Neither can be reconstructed from the available summary counts without making choices that the registry does not document.
Thus, the record supports a description of the trial’s design and selected safety counts, but not a conclusion about the primary efficacy contrast. Missing analysis details also limit interpretation of the safety figures. The figures describe what the registry lists; they do not alone establish causation, comparative benefit, or the balance of outcomes for an individual.
9. Statistical Methods Explained
The registry describes a randomized, double-masked, parallel-group Phase III study. General statistical methods help explain what such design features are intended to accomplish, but the registry record does not report the full statistical analysis plan. The information below therefore distinguishes general principles from methods documented for this study.
What does randomization contribute?
In general, random assignment aims to make groups comparable, on average, with respect to both measured and unmeasured characteristics at the start of a study. It supports a causal comparison when the assignment process is preserved and participants are analyzed appropriately. Randomization does not guarantee that groups will be identical, particularly in a finite study. The registry record does not describe the sequence-generation method, allocation concealment, stratification factors, or the planned approach to analyzing participants according to assignment.
What does masking contribute?
Masking can reduce the influence of treatment knowledge on participant expectations, clinical management, outcome assessment, and reporting. The registry specifies double masking, but does not identify which roles were masked or describe whether masking was assessed. The design label alone cannot establish how effectively masking was maintained.
How is a recurrence outcome analyzed?
In general, a binary endpoint records whether each participant experienced an event during a defined observation period. It can be summarized by the number of participants with the event and the number evaluated in each group. A comparative analysis may estimate a difference or ratio between groups, often with a confidence interval. The choice of effect measure and statistical model should be specified in advance, particularly when follow-up differs or data are incomplete. The registry record describes recurrence as a proportion but does not report group-specific recurrence counts, the comparative estimate, its uncertainty, or the analysis model.
The timing description is important for this endpoint. The efficacy wording refers to recurrence within 6 months after treatment, while other wording refers to recurrence at 36 months. General practice requires a clearly defined time origin and assessment window so that the event status has a consistent meaning. The record does not explain the apparent discrepancy, how repeat recurrences were handled, or whether participants with incomplete follow-up contributed to the analysis.
What does a confidence interval express?
In general, a confidence interval communicates statistical uncertainty around an estimated effect under the assumptions of the chosen method. A narrow interval indicates greater precision than a wide interval, although precision alone does not determine clinical importance. An interval crossing a null value does not prove there is no effect; it indicates that the data are compatible with a range of values under the method. No interval for the primary recurrence comparison is reported in the registry record, so its precision cannot be evaluated.
How should p-values be understood?
In general, a p-value measures how unusual data at least as extreme as those observed would be under a specified null hypothesis and model. It does not give the probability that the null hypothesis is true, and it does not measure the size or importance of an effect. Interpretation depends on the endpoint, analysis population, model, and any multiplicity considerations. The registry record does not report a primary efficacy p-value or the analysis details needed to interpret one.
What do the safety counts represent?
Event counts and affected-participant counts are different summaries. A participant can experience more than one event, so event totals need not equal the number of participants affected. The registry’s serious adverse-event figures list affected participants and participants at risk by arm; the other adverse-event figures are likewise listed as affected and at risk. These descriptive counts do not show the timing, duration, severity beyond the serious-event classification, or statistical uncertainty for a group comparison. General safety analyses may examine event types, exposure time, recurrent events, and between-group uncertainty, but those methods are not documented in the registry record.
What can sample-size illustrations say?
General sample-size calculations describe how many participants might be needed under specified assumptions about the effect to detect, significance level, allocation, and statistical method. The registry’s stated illustration assumptions use a two-sided significance level of 0.05, equal allocation, a normal approximation, and fractions of an observed effect. Such illustrations are planning aids, not observed power and not proof that a study was adequately powered. Because the primary outcome is not reduced to one comparison, a single outcome-based comparison is not presented in the registry information used for this analysis.
The record does not report the trial’s original sample-size justification, whether interim analyses were conducted, or a complete statistical plan. No conclusions about those procedures should be inferred from the design label or the observed enrollment. The absence of reported analysis results also means the primary endpoint cannot be independently evaluated using the registry information alone.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome description combines recurrence of uveitis with an overall summary of ocular treatment-emergent adverse events. The recurrence wording also contains different time references: within 6 months after treatment in the efficacy description, and at 36 months in the title and population description. These features raise questions about which outcomes and time points were intended to support the primary conclusion. The registry record does not report a multiplicity strategy or clarify the relationship between the outcome components.
Multiplicity is a general statistical concern when several outcomes, time points, or comparisons are tested. The more questions examined, the greater the chance that at least one result appears unusual by chance if no adjustment or prespecified hierarchy is used. Methods such as a testing hierarchy or adjustment can address this concern, but the registry record does not report whether any such approach was planned. It would be inappropriate to assume that an adjustment was or was not used.
Missing-data methods are also not reported. In general, incomplete outcome assessment can affect a binary endpoint if participants with missing follow-up differ in their likelihood of recurrence. Interpretation depends on how missing status is defined and handled, and on whether sensitivity analyses assess alternative assumptions. The record does not describe missingness by group or any method for addressing it.
The endpoint description identifies an ITT population for recurrence and a Safety Population for ocular adverse events. These labels indicate that the record distinguishes efficacy and safety populations, but their operational definitions are not reported. The record does not explain exclusions, treatment discontinuation, crossover handling, or whether all randomized participants were included in the efficacy analysis. It also lists zero analyses, so no analysis population results are available to assess.
Accordingly, neither the control of multiplicity nor the handling of missing data and analysis populations can be evaluated from the registry record. These omissions limit interpretation of the primary efficacy question and of any apparent contrast between groups.
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 |
|---|---|---|---|
| Sham Injection | 17 | 42 | 40.5% |
| FAI Insert | 29 | 87 | 33.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Sham Injection | 0 of 42 |
| FAI Insert | 1 of 87 |
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 |
|---|---|
| Sham Injection | 40 of 42 |
| FAI Insert | 84 of 87 |
Most frequent serious adverse event terms
| Event term | Organ system | Sham Injection | FAI Insert |
|---|---|---|---|
| Cataract | Eye disorders | 1 of 42 | 7 of 87 |
| Uveitis | Eye disorders | 4 of 42 | 2 of 87 |
| Intraocular pressure increased | Investigations | 1 of 42 | 2 of 87 |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | 0 of 42 | 2 of 87 |
| Glaucoma | Eye disorders | 1 of 42 | 1 of 87 |
| Macular oedema | Eye disorders | 2 of 42 | 0 of 87 |
| Non-infectious endophthalmitis | Eye disorders | 2 of 42 | 0 of 87 |
| Foot deformity | Musculoskeletal and connective tissue disorders | 0 of 42 | 1 of 87 |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | 0 of 42 | 1 of 87 |
| Angina pectoris | Cardiac disorders | 1 of 42 | 0 of 87 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Sham Injection | FAI Insert |
|---|---|---|---|
| Uveitis | Eye disorders | 26 of 42 | 18 of 87 |
| Intraocular pressure increased | Investigations | 13 of 42 | 28 of 87 |
| Cataract | Eye disorders | 6 of 42 | 33 of 87 |
| Cystoid macular oedema | Eye disorders | 12 of 42 | 12 of 87 |
| Macular oedema | Eye disorders | 16 of 42 | 6 of 87 |
| Visual acuity reduced | Eye disorders | 5 of 42 | 16 of 87 |
| Dry eye | Eye disorders | 5 of 42 | 15 of 87 |
| Eye pain | Eye disorders | 9 of 42 | 11 of 87 |
| Conjunctival haemorrhage | Eye disorders | 5 of 42 | 13 of 87 |
| Nasopharyngitis | Infections and infestations | 5 of 42 | 12 of 87 |
Serious events with the highest arm-level rate: uveitis (9.5%), cataract (8.0%), macular oedema (4.8%), non-infectious endophthalmitis (4.8%), angina pectoris (2.4%).
The registry lists serious adverse events by group as affected participants and participants at risk. For Sham Injection, 17 of 42 participants are listed as affected; for FAI Insert, 29 of 87 are listed as affected. Deaths are listed as 0 and 1, respectively. The record also lists other adverse events: 40 of 42 for Sham Injection and 84 of 87 for FAI Insert. These are descriptive counts, not adjusted comparisons.
The serious-event terms listed are Uveitis at 9.5%, Cataract at 8.0%, Macular oedema at 4.8%, Non-infectious endophthalmitis at 4.8%, Angina pectoris at 2.4%, and Diarrhoea at 2.4%. The listed information does not identify whether those percentages are arm-specific or provide denominator details for each term. They should not be read as comparative group risks.
General interpretation of safety data distinguishes participants affected from the total number of events: one participant may have more than one event. Counts alone also omit timing, duration, and uncertainty. The record does not report a statistical comparison of the serious adverse-event counts or enough detail to assess exposure-adjusted rates. These figures describe recorded safety events; they do not establish that an intervention caused an event or determine the overall balance of safety and efficacy.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized, double-masked, parallel-group study compared an FAI insert with sham injection in subjects with chronic non-infectious uveitis affecting the posterior segment. It describes recurrence in the study eye as the primary efficacy question and lists ocular treatment-emergent adverse events as a safety outcome. It also provides selected safety counts and serious-event terms.
What the record does not establish is the magnitude or direction of the primary efficacy comparison. It does not report recurrence counts by group, an effect estimate, a confidence interval, or a p-value. The recurrence period is described differently in the efficacy wording and the title and population wording, and the registry does not explain the difference. Without those details, the central efficacy result cannot be interpreted for its size, precision, or relevance to the stated assessment period.
The safety information is also limited. The affected-participant counts and listed deaths are descriptive, and the term percentages lack enough accompanying detail to establish arm-specific risks. No adjustment, uncertainty interval, or formal safety comparison is reported in the registry record. The counts therefore should not be treated as proof that one group had better or worse overall safety.
General statistical interpretation separates evidence of an observed difference from evidence about its uncertainty and practical importance. A point estimate, confidence interval, outcome definition, and analysis population are all important to that interpretation. They are not available for the primary efficacy comparison in this record. Nor does a completed status indicate that a particular result was favorable, conclusive, or statistically significant.
The defensible conclusion is limited: the registry describes the study question and design and reports selected adverse-event counts, but it does not provide a reportable primary efficacy comparison. The available record cannot establish whether recurrence differed between the randomized groups or how precisely any difference was estimated. It also cannot support a treatment recommendation or a conclusion about individual care.
13. Why This Trial Matters Statistically
This study illustrates why a trial’s design and its reported results must be considered separately. Randomization and masking describe features intended to support a fair comparison, but they do not reveal the observed effect or its precision. The registry record identifies the intervention, comparator, population, and recurrence question, yet the numerical recurrence comparison is not reported. A reader can understand what was intended to be evaluated without being able to assess the primary efficacy finding.
The endpoint wording also demonstrates the importance of an explicit time definition. Recurrence within 6 months after treatment and recurrence at 36 months are not interchangeable descriptions. A time window affects which events count and how the outcome is interpreted. When the record does not clarify the relationship between time references, an analyst should preserve that uncertainty rather than choose an interpretation.
The safety summaries illustrate another core statistical distinction: descriptive counts are not the same as a comparative analysis. A count of affected participants conveys useful information about recorded events, but without an effect estimate and uncertainty it does not quantify how reliably groups differ. Serious-event term percentages also need denominators and group attribution to support risk comparisons.
Finally, the record shows why missing analysis details matter. The absence of reported recurrence results, a stated multiplicity approach, missing-data methods, and operational definitions for analysis populations restricts reproducibility and interpretation. These are not merely technical details; they determine what population and question a reported estimate would represent. The trial’s statistical importance lies in the questions it raises about endpoint clarity and the difference between a study’s design and the evidence available in its registry record.
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 central limitation is that the registry record does not report a numerical primary efficacy comparison. Recurrence counts by group, an effect estimate, uncertainty interval, and p-value are not reported. This prevents assessment of the direction, magnitude, or precision of the endpoint identified as primary.
The recurrence timing is not consistently described: the efficacy description refers to recurrence within 6 months after treatment, while the title and population wording refer to recurrence at 36 months. The registry record does not explain whether these refer to different assessments or how the primary question should be interpreted. The outcome description also combines efficacy and safety information, without a reported multiplicity approach.
Details needed to reproduce or evaluate the analysis are not reported, including the statistical model, handling of missing outcomes, operational definitions of the ITT and Safety populations, and the treatment of discontinuations or other deviations. The record lists zero analyses. Although it gives selected adverse-event counts, it does not provide an adjusted comparative safety analysis or denominator details for the listed serious-event term percentages.
The registry record gives an enrollment of 129 but does not report the original sample-size justification or whether interim analyses occurred. Any planning illustrations based on observed effects are not observed power and cannot replace the missing primary results. These limitations apply to interpretation of the registry information; they do not establish what may or may not be reported elsewhere.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal Insert — NCT01694186.
- Registry record last updated 2021-04-02; status last verified 2021-03.
- Results first posted 2020-03-23.
- 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
The registry describes a completed Phase III, multinational, multicenter, randomized, double-masked, parallel-group study of an FAI insert versus sham injection in subjects with chronic non-infectious uveitis affecting the posterior segment. It lists enrollment of 129 and identifies recurrence in the study eye as the primary efficacy question, alongside ocular treatment-emergent adverse-event summaries.
The efficacy description refers to recurrence within 6 months after treatment, while other endpoint wording refers to recurrence at 36 months. The registry record does not reconcile these time references or report the recurrence comparison. It lists selected serious and other adverse-event counts and serious-event terms, but no comparative analysis of these outcomes. The primary efficacy estimate and its precision are therefore not available from the registry record.