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 A 12 Month Core Study to Assess the Efficacy and Safety of Ranibizumab (Intravitreal Injections) in Patients With Visual Impairment Due to Diabetic Macular Edema and a 24 Month Open-label Extension Study (NCT00687804), a randomized phase 3 study. The primary outcome is Core Study: Difference Between the Baseline Level of Visual Acuity (Letters) of the Study Eye and the Mean Visual Acuity Averaged Over All Monthly Post-baseline Assessments From Month 1 to Month 12.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00687804 |
| Phase | Phase 3 |
| Condition | Diabetic Macular Edema |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 345 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Novartis |
| Results posted | Yes |
2. Clinical Question
Population
The study enrolled patients with visual impairment due to diabetic macular edema. The registry record reports total enrollment of 345. The core-study analysis population is described as patients who received at least one application of study treatment and had at least one post-baseline best corrected visual acuity assessment. The registry record does not report further eligibility criteria in the available description.
Intervention
The intervention of interest was ranibizumab 0.5 mg given by intravitreal injection. The record describes monthly injections for 3 months and includes an arm receiving ranibizumab with laser photocoagulation. It also lists ranibizumab monotherapy and an extension in which participants could receive ranibizumab. The full treatment rules are not reported in the registry record.
Comparator
The core study included laser photocoagulation as a comparator, with monthly sham intravitreal injections described for the laser arm. The listed interventions also include sham laser and sham ranibizumab. The registry record does not provide a complete account of the allocation across all groups or the full masking procedures.
Primary question
The primary endpoint concerns visual acuity in the study eye: it compares the baseline level with the mean of monthly post-baseline assessments from Month 1 to Month 12. The clinical question is whether visual acuity measurements over that period differ across the randomized treatment groups. Numerical primary-endpoint results and a between-group estimate are not reported in the registry record, so the direction and precision of any treatment contrast cannot be assessed from the record.
3. Trial Design
This was a randomized, parallel-group Phase III study with triple masking, according to the registry record. The core study was designed to assess ranibizumab 0.5 mg as monotherapy and as an addition to laser photocoagulation in patients with visual impairment due to diabetic macular edema. Laser photocoagulation was also used as a control treatment. The registry record lists ranibizumab, laser, sham laser, and sham ranibizumab among the interventions.
The core study evaluated the primary visual-acuity endpoint through Month 12. The registry record describes monthly ranibizumab injections for 3 months; after the third injection, treatment could be suspended under criteria that are truncated in the available arm descriptions. The laser arm received laser on Day 1 and at intervals of at least 3 months when considered necessary by the physician, as well as monthly sham injections for 3 consecutive months. Additional treatment details are not reported in the registry record.
The record also describes a 24-month open-label extension for participants who completed the core study. This extension evaluated longer-term safety and efficacy, with the brief summary describing ranibizumab as symptomatic treatment. Extension groups are listed as laser with ranibizumab in the extension and laser without ranibizumab in the extension. Because the extension was open-label and included core-study completers, its participants and treatment context differ from those of the randomized core study.
Total enrollment was 345. The registry record lists Novartis as sponsor and the study status as completed. The allocation ratio, randomization procedure, details of who was masked, and the sample-size justification are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: Participants who completed the 12 month randomized core study CRFB002D2301 were eligible to participate in the 24 month open-label extension study CRFB002D2301E1. The reporting groups for the participants in the extension study are according to their assigned treatment groups in the core study.
Core Study
| Stage | Ranibizumab 0.5 mg | Ranibizumab 0.5 mg + Laser | Laser |
|---|---|---|---|
| STARTED | 116 | 118 | 111 |
| COMPLETED | 102 | 103 | 98 |
| NOT COMPLETED | 14 | 15 | 13 |
Reasons for not completing this period:
| Reason | Ranibizumab 0.5 mg | Ranibizumab 0.5 mg + Laser | Laser |
|---|---|---|---|
| Adverse Event | 5 | 3 | 3 |
| Abnormal laboratory value(s) | 1 | 0 | 0 |
| Lack of Efficacy | 1 | 1 | 1 |
| Withdrawal by Subject | 4 | 7 | 7 |
| Lost to Follow-up | 0 | 1 | 0 |
| Death | 2 | 2 | 2 |
| Protocol Violation | 1 | 1 | 0 |
Open-Label Extension Study
| Stage | Ranibizumab 0.5 mg | Ranibizumab 0.5 mg + Laser | Laser |
|---|---|---|---|
| STARTED | 83 | 83 | 74 |
| Did Not Receive Ranibizumab in Extension | 16 | 21 | 15 |
| COMPLETED | 73 | 72 | 63 |
| NOT COMPLETED | 10 | 11 | 11 |
Reasons for not completing this period:
| Reason | Ranibizumab 0.5 mg | Ranibizumab 0.5 mg + Laser | Laser |
|---|---|---|---|
| Adverse Event | 2 | 2 | 2 |
| Subject withdrew consent | 3 | 4 | 4 |
| Lost to Follow-up | 2 | 1 | 2 |
| Administrative problems | 1 | 1 | 0 |
| Death | 2 | 3 | 3 |
Analysis population for the primary outcome, as defined in the registry: Full analysis set consists of all patients who received at least one application of study treatment and had at least one post-baseline assessment for BCVA. Following the intent to treat principle, patients were analyzed according to the treatment assigned. Last Observation Carried Forward (LOCF) imputation was utilized.
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.
| Characteristic | Unit | Ranibizumab 0.5 mg | Ranibizumab 0.5 mg + Laser | Laser | Total |
|---|---|---|---|---|---|
| Participants analysed | 116 | 118 | 111 | 345 | |
| Age Continuous | years | 62.9 (SD 9.29) | 64.0 (SD 8.15) | 63.5 (SD 8.81) | 63.5 (SD 8.75) |
| Age, Customized: < 55 years | Participants | 24 | 14 | 13 | 51 |
| Age, Customized: 55 - <65 years | Participants | 41 | 42 | 53 | 136 |
| Age, Customized: 65 - <75 years | Participants | 40 | 53 | 31 | 124 |
| Age, Customized: >=75 years | Participants | 11 | 9 | 14 | 34 |
| Sex: Female, Male: Female | Participants | 43 | 48 | 53 | 144 |
| Sex: Female, Male: Male | Participants | 73 | 70 | 58 | 201 |
6. Primary Endpoint
The registry lists the primary outcome as Core Study: Difference Between the Baseline Level of Visual Acuity (Letters) of the Study Eye and the Mean Visual Acuity Averaged Over All Monthly Post-baseline Assessments From Month 1 to Month 12, measured over Baseline through the end of study (Month 12).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Letters |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is a continuous visual-acuity measure for the study eye. Visual acuity was assessed at study visits in both eyes using best correction determined from protocol refraction. Participants read an Early Treatment Diabetic Retinopathy Study-like chart at a testing distance of 4 meters, and the outcome was the number of letters correctly identified. The endpoint compares baseline visual acuity with the mean visual acuity averaged across monthly assessments from Month 1 through Month 12.
As a general statistical point, repeated assessments can describe a participant’s visual-acuity course more fully than a single visit. Averaging across scheduled post-baseline visits can represent the overall level during follow-up, although it does not by itself show how the outcome changed at each visit. The registry record specifies the time window and measurement approach, but does not report the numerical group means, variability, or a treatment contrast for this primary endpoint.
The endpoint is useful for comparing a functional measure across randomized groups. A mean difference can summarize the average separation between groups, while its uncertainty depends on the observed variability and the analysis method. Without the posted numerical estimates and their precision, the size and uncertainty of any difference cannot be described.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies visual acuity averaged over monthly post-baseline assessments from Month 1 to Month 12 as the primary endpoint. It does not report numerical results for this endpoint: group means, a between-group estimate, a confidence interval, and a p-value are not reported in the registry record. Consequently, the record does not support a statistical description of the primary comparison’s direction, magnitude, or precision.
The study’s design establishes that participants were randomized and that the core study used a parallel-group structure. Randomization can support a fair comparison at the start of a trial, in general, because treatment assignment is not chosen by the participants or investigators. It does not replace the need to inspect the actual endpoint estimates, missing-data handling, and analysis population. Those details are limited in the available registry description.
The outcome is a mean of repeated visual-acuity measurements, rather than a single end-of-study reading. In general, such an average can reflect the overall level across follow-up visits. It can also obscure variation in the course over time: two groups could have different patterns at individual visits but similar overall averages, or the reverse. The record lists other visual-acuity outcomes, including change at Month 12 and change over time, but numerical findings for them are not reported in the registry record.
The record lists secondary outcomes covering categorized visual-acuity change, mean visual-acuity change over time, retinal thickness, patient-reported visual functioning, and safety during the core and extension studies. Outcome names describe what was intended to be assessed; they are not evidence of an observed treatment effect. Numerical results for these outcomes are not reported in the registry record.
The adverse-event entries provide counts of affected participants and participants at risk for the listed groups. These counts describe events recorded in each group, but do not establish that treatment caused them. The record also lists selected serious adverse-event terms with percentages. It does not provide enough detail in those entries to determine comparative risks for those terms across randomized groups. Overall, the registry record permits description of the trial question and selected safety counts, but not estimation of the primary treatment effect.
9. Statistical Methods Explained
What does the primary measure represent?
The endpoint is a continuous measure: the number of letters correctly identified on an ETDRS-like visual-acuity chart. The endpoint description specifies an average across monthly assessments from Month 1 to Month 12 and comparison with baseline. A continuous outcome retains information about the measured value rather than reducing it to a category such as improved or not improved. In general, analysis of a continuous endpoint often summarizes groups using means and a measure of variability. The registry record identifies the mean and standard deviation as the measure and dispersion type, but does not report the numerical results for the primary endpoint.
A mean describes the central level of a set of measurements. A standard deviation describes how spread out individual measurements are around the mean. These answer different questions: the mean concerns the average outcome, while the standard deviation concerns variation among observations. Neither alone describes the precision of a between-group estimate; that generally requires an uncertainty measure such as a confidence interval. A confidence interval, in general, gives a range of values compatible with the data and the specified analysis, subject to its assumptions. No primary-endpoint confidence interval is reported in the registry record.
Why use repeated assessments?
The trial assessed visual acuity repeatedly, and the primary measure averages the post-baseline visits over the stated period. In general, repeated measurements can capture an outcome across follow-up rather than relying on a single visit. Averaging can reduce emphasis on an unusually high or low reading at one time, but it does not show the trajectory at each visit. The record lists a separate secondary outcome for mean change over time, but its numerical findings are not reported in the registry record.
Repeated observations from the same participant are usually related rather than independent. As a general statistical matter, methods for repeated measurements need to account for that within-participant relationship if they analyze individual visits together. A simple average is one way to define a participant-level outcome, but the registry record does not report the full primary analysis method or how within-participant data were handled.
What is known about the analysis population?
The endpoint description defines the full analysis set as participants who received at least one application of study treatment and had at least one post-baseline assessment for best corrected visual acuity. It also says participants were analyzed according to assigned treatment, consistent with an intent-to-treat principle as described in the registry. The full details of exclusions, analysis implementation, and sensitivity analyses are not reported in the registry record.
The population description begins to mention last observation carried forward, but the remainder of that text is truncated. Last observation carried forward is a missing-data approach that, in general, substitutes a participant’s last recorded value for a later missing value. This approach can make assumptions about what would have happened after the last observed measurement. The precise use of the method, the amount and pattern of missing data, and any alternative analyses are not reported in the registry record.
What can the planning illustrations tell readers?
The planning assumptions describe illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. The effect to detect is expressed as a stated fraction of the observed effect. Such calculations are planning illustrations, not observed power and not evidence that the trial had a particular probability of detecting an effect. The sample-size justification used when designing the trial is not reported in the registry record. No planning sample-size values are reported in the record details available for this analysis.
In general, a planning calculation depends on assumptions about the effect size, variability, significance level, allocation, and statistical method. If those assumptions differ from the actual study data or intended analysis, the resulting illustration may not reflect the trial’s design. The registry record does not report the full derivation of its sample-size assumptions or the trial’s own design calculation.
How should significance and uncertainty be read?
A p-value, in general, measures how incompatible the observed data are with a specified null model, under the assumptions of the test. It is not the probability that a treatment effect is true, and it does not measure the size or clinical importance of an effect. A confidence interval adds information about the range and precision of an estimate. Since neither a primary p-value nor an estimate and confidence interval are reported in the registry record, those aspects of the primary result cannot be evaluated.
For outcomes with several visits or categories, multiple comparisons can raise the chance of at least one apparently unusual result when each test is considered separately. The registry lists multiple secondary outcomes, but the multiplicity strategy is not reported in the registry record. Accordingly, no claim about adjustment or control of multiple testing can be made.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists multiple secondary outcomes, including categorized visual-acuity change, visual-acuity change over time, central retinal thickness, patient-reported visual functioning, and ocular and non-ocular adverse events. The primary endpoint itself averages assessments across multiple post-baseline visits. When many outcomes, time points, or categories are examined, there are multiple opportunities for apparently notable findings. As a general statistical issue, a prespecified multiplicity strategy can help control the interpretation of multiple tests. Whether such a strategy was used is not reported in the registry record.
The record does not provide numerical primary-endpoint results or an analysis record for that endpoint. It also does not report a complete statistical analysis plan, an interim-analysis plan, or a hierarchy for primary and secondary tests. The stated sample-size assumptions are planning illustrations based on an observed effect; they do not supply evidence about the actual analysis or its multiplicity handling.
The full analysis set is described as including participants who received at least one application of study treatment and had at least one post-baseline visual-acuity assessment, with participants analyzed according to assigned treatment. The endpoint description begins to refer to last observation carried forward, but the text is truncated. The extent of missing data, reasons for missingness, exact imputation procedure, and sensitivity analyses are not reported in the registry record. These omissions matter because estimates can depend on which participants and observations are included and on assumptions made for missing measurements.
The extension included participants who completed the core study and was open-label. The registry record does not describe how selection into the extension was handled in analyses. Results from that phase therefore cannot automatically be interpreted as if they came from the original randomized comparison.
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 |
|---|---|---|---|
| Ranibizumab 0.5 mg | 41 | 115 | 35.7% |
| Ranibizumab 0.5 mg + Laser | 43 | 120 | 35.8% |
| Laser With Ranibizumab in Extension | 28 | 59 | 47.5% |
| Laser Without Ranibizumab in Extension | 7 | 51 | 13.7% |
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 |
|---|---|
| Ranibizumab 0.5 mg | 79 of 115 |
| Ranibizumab 0.5 mg + Laser | 83 of 120 |
| Laser With Ranibizumab in Extension | 50 of 59 |
| Laser Without Ranibizumab in Extension | 31 of 51 |
Most frequent serious adverse event terms
| Event term | Organ system | Ranibizumab 0.5 mg | Ranibizumab 0.5 mg + Laser | Laser With Ranibizumab in Extension | Laser Without Ranibizumab in Extension |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | 1 of 115 | 4 of 120 | 3 of 59 | 0 of 51 |
| Cardiac failure | Cardiac disorders | 1 of 115 | 1 of 120 | 4 of 59 | 1 of 51 |
| Diabetic foot | Metabolism and nutrition disorders | 2 of 115 | 0 of 120 | 3 of 59 | 1 of 51 |
| Coronary artery disease | Cardiac disorders | 3 of 115 | 1 of 120 | 1 of 59 | 0 of 51 |
| Cataract (Study eye) | Eye disorders | 0 of 115 | 3 of 120 | 2 of 59 | 0 of 51 |
| Cerebrovascular accident | Nervous system disorders | 3 of 115 | 1 of 120 | 1 of 59 | 0 of 51 |
| Angina pectoris | Cardiac disorders | 3 of 115 | 1 of 120 | 0 of 59 | 0 of 51 |
| Cataract (Fellow eye) | Eye disorders | 2 of 115 | 1 of 120 | 1 of 59 | 0 of 51 |
| Vitreous haemorrhage (Fellow eye) | Eye disorders | 2 of 115 | 0 of 120 | 1 of 59 | 1 of 51 |
| Pneumonia | Infections and infestations | 0 of 115 | 1 of 120 | 3 of 59 | 0 of 51 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Ranibizumab 0.5 mg | Ranibizumab 0.5 mg + Laser | Laser With Ranibizumab in Extension | Laser Without Ranibizumab in Extension |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | 18 of 115 | 21 of 120 | 15 of 59 | 8 of 51 |
| Diabetic retinal oedema (Fellow eye) | Eye disorders | 12 of 115 | 19 of 120 | 11 of 59 | 3 of 51 |
| Eye pain (Study eye) | Eye disorders | 15 of 115 | 11 of 120 | 13 of 59 | 2 of 51 |
| Cataract (Study eye) | Eye disorders | 9 of 115 | 17 of 120 | 9 of 59 | 4 of 51 |
| Hypertension | Vascular disorders | 15 of 115 | 11 of 120 | 6 of 59 | 6 of 51 |
| Cataract (Fellow eye) | Eye disorders | 10 of 115 | 12 of 120 | 7 of 59 | 5 of 51 |
| Influenza | Infections and infestations | 12 of 115 | 8 of 120 | 8 of 59 | 5 of 51 |
| Conjunctival hyperaemia (Study eye) | Eye disorders | 9 of 115 | 8 of 120 | 5 of 59 | 2 of 51 |
| Conjunctival haemorrhage (Study eye) | Eye disorders | 9 of 115 | 13 of 120 | 0 of 59 | 0 of 51 |
| Back pain | Musculoskeletal and connective tissue disorders | 7 of 115 | 5 of 120 | 8 of 59 | 1 of 51 |
Serious events with the highest arm-level rate: cardiac failure (6.8%), myocardial infarction (5.1%), pneumonia (5.1%), diabetic foot (5.1%), acute myocardial infarction (3.4%).
The registry record lists counts of participants affected by serious adverse events and other adverse events, alongside the number at risk in each listed group. For ranibizumab 0.5 mg, the serious-event count is 41 among 115 at risk, and the other-event count is 79 among 115 at risk. For ranibizumab 0.5 mg plus laser, the corresponding counts are 43 among 120 and 83 among 120. The extension groups list 28 serious-event participants among 59 at risk and 50 other-event participants among 59 for laser with ranibizumab in the extension; laser without ranibizumab in the extension lists 7 among 51 and 31 among 51.
These are participant counts, not counts of individual event episodes. A participant may experience more than one event, and the registry record does not provide event timing or a full account of exposure for each group. The extension groups also belong to an open-label phase among core-study completers, so they should not be treated as interchangeable with the randomized core groups.
Listed serious-event terms include cardiac failure, myocardial infarction, pneumonia, diabetic foot, acute myocardial infarction, and cataract in the study eye, with percentages recorded for each term. The record does not establish that these events were caused by study treatment. Death counts are not reported in the registry record. Safety counts should be read as descriptive information, not as a standalone causal comparison.
12. What the Result Does, and Does Not, Mean
The registry record establishes the broad question and structure of a randomized Phase III trial of ranibizumab alone or with laser photocoagulation for visual impairment due to diabetic macular edema. It identifies a primary endpoint based on visual acuity measured in letters and averaged across monthly assessments from Month 1 through Month 12. It also describes an open-label extension for participants who completed the core study.
However, the registry record does not report the numerical primary-endpoint results. Without group estimates, a between-group contrast, or uncertainty measures, readers cannot determine from this record how large or precise a difference was. The record also does not report numerical results for its listed secondary outcomes. This absence should not be read as evidence that there was no effect or that there was an effect; it means the registry record does not provide the results needed to assess either conclusion.
The safety entries describe affected-participant counts in the named groups and percentages for selected serious adverse-event terms. They are useful as descriptive registry entries, but they do not by themselves establish causation or provide a complete comparative safety analysis. The open-label extension has a different design context from the randomized core study, so its entries should be interpreted separately.
In general, a treatment comparison is best understood by considering the size of the estimate, its uncertainty, the analysis population, missing-data assumptions, and the design. Here, several of those details are not reported in the registry record. The study title and outcome definitions describe intended evaluation; they do not substitute for posted numerical findings. No medical conclusion about benefit or lack of benefit can be drawn from the endpoint description alone.
13. Why This Trial Matters Statistically
This trial illustrates an important distinction in clinical-trial interpretation: a detailed outcome definition is not the same as a reported outcome result. The record identifies a continuous visual-acuity endpoint, its study-eye focus, its measurement instrument, and its follow-up window. Those details clarify what the investigators intended to evaluate, but the numerical estimates needed to assess the treatment comparison are not reported in the registry record.
The endpoint also uses repeated measurements rather than a single visit. In general, that choice can represent average visual acuity across follow-up, while leaving the visit-by-visit pattern to other analyses. The registry lists a separate outcome for change over time, demonstrating that a trial may define several related views of the same clinical domain. The results and multiplicity approach for those outcomes are not reported in the registry record.
The study includes both a randomized core phase and an open-label extension. Statistically, these phases address different questions: the core phase is described as randomized, while the extension involved participants who completed the core study and knew the treatment context was open-label. Keeping those designs distinct is important when interpreting any eventual comparison.
Finally, the registry describes an analysis population and begins to mention an approach to missing values, but the full methods are not available in the record. Such details can affect interpretation of a repeated continuous endpoint. This example underscores why clear estimates, uncertainty intervals, analysis-population definitions, and complete missing-data methods are needed alongside a trial’s design and outcome descriptions.
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 for interpreting efficacy is that numerical primary-endpoint results are not reported in the registry record. The record therefore does not permit assessment of the treatment contrast, its precision, or its statistical significance. Numerical results for the listed secondary outcomes are also not reported in the registry record.
Several design and analysis details are absent. The randomization procedure, allocation ratio, specific masking arrangements, full statistical analysis method, and sample-size justification are not reported in the registry record. The primary analysis population is described, but its text concerning last observation carried forward is truncated. The amount and pattern of missing data and the use of sensitivity analyses are not reported in the registry record.
The arm descriptions are also truncated, including the criteria for suspending ranibizumab after the third injection. This limits interpretation of treatment exposure and of the full treatment regimen. The open-label extension included participants who completed the core study, so it represents a selected group rather than necessarily the full original randomized population. The registry record does not report how that selection was addressed analytically.
Safety entries provide counts of affected participants and selected serious-event terms, but do not provide a complete causal assessment. The record does not report death counts. It also does not report the multiplicity strategy for the several outcomes and assessment times. These limitations leave important uncertainty about both efficacy interpretation and the completeness of the statistical methods.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A 12 Month Core Study to Assess the Efficacy and Safety of Ranibizumab (Intravitreal Injections) in Patients With Visual Impairment Due to Diabetic Macular Edema and a 24 Month Open-label Extension Study — NCT00687804.
- Registry record last updated 2013-04-01; status last verified 2013-03.
- Results first posted 2011-04-19.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
This completed randomized, triple-masked, parallel-group Phase III study enrolled 345 participants with visual impairment due to diabetic macular edema. The 12-month core study evaluated ranibizumab 0.5 mg, including use with laser photocoagulation, and included a laser control. A 24-month open-label extension was intended for core-study completers.
The primary endpoint was visual acuity in the study eye, comparing baseline with mean monthly assessments from Month 1 to Month 12. The registry record describes the measurement procedure and an analysis population but does not report numerical primary-endpoint results. Listed secondary outcomes address visual acuity, retinal thickness, patient-reported function, and adverse events; their numerical findings are not reported in the registry record. Safety entries contain affected-participant counts and selected serious-event terms, but do not establish causation. The full statistical analysis plan, multiplicity approach, and missing-data handling are not reported in the registry record.