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 Efficacy/Safety of Verteporfin Photodynamic Therapy and Ranibizumab Compared With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization (NCT00436553), a randomized phase 3 study. The primary outcome is Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) of the Study Eye at Month 12.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00436553 |
| Phase | Phase 3 |
| Condition | Macular Degeneration, Choroidal Neovascularization |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 321 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Novartis |
| Results posted | Yes |
2. Clinical Question
Population
The study enrolled patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration. Its primary endpoint was defined for the study eye. The primary analysis population was the Full analysis set: randomized patients who received at least one application of study drug and had at least one post-baseline assessment of best-corrected visual acuity in the study eye. Last observation carried forward was used for this endpoint. The registry record does not report further eligibility details or the baseline characteristics of the analyzed population.
Intervention
The combination strategy paired ranibizumab with verteporfin photodynamic therapy. The listed combination groups used either standard fluence or reduced fluence. The available descriptions state that these groups received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, followed by injections as needed under retreatment criteria. They also describe verteporfin treatment on Day 1, but the arm descriptions are truncated, so the complete retreatment schedules are not reported in the registry record.
Comparator
The comparator was ranibizumab monotherapy. Its description states that ranibizumab was given monthly for 12 months and thereafter as needed under retreatment criteria. The group also received verteporfin placebo infusion with sham photodynamic therapy on Day 1, with further placebo procedures described from Month 3. The available description is truncated; the full schedule is not reported in the registry record.
Primary question
The study asked whether adding verteporfin photodynamic therapy to ranibizumab was associated with a different mean change from baseline in study-eye best-corrected visual acuity at Month 12, compared with ranibizumab alone. The registry record gives the endpoint definition but does not report the group results or a treatment-effect estimate. It therefore does not establish the direction, size, or precision of any difference in this primary outcome. The study description also mentions visual-acuity and anatomic outcomes and durability of response, but no conclusion about those effects can be drawn from the information reported in the registry record.
3. Trial Design
This was a randomized, quadruple-masked, parallel-group Phase IIIB study. Its official title describes a 24-month study of verteporfin photodynamic therapy administered with ranibizumab versus ranibizumab monotherapy in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration. The registry lists enrollment of 321. The sponsor was Novartis. The recorded start was 2007-02, primary completion was 2009-10, and status is completed.
The listed treatment groups were verteporfin photodynamic therapy with standard fluence plus ranibizumab, verteporfin photodynamic therapy with reduced fluence plus ranibizumab, and ranibizumab monotherapy. The arm descriptions indicate that the combination groups began ranibizumab with consecutive monthly injections and then used treatment as needed according to retreatment criteria. The monotherapy description states monthly injections for 12 months and then treatment as needed. Each description is incomplete in the registry record, so details beyond the text reported there should not be inferred.
Random allocation is intended to reduce systematic differences in baseline characteristics between treatment groups. Masking can reduce the influence of treatment expectations on care, assessment, and reporting. A parallel-group design compares assigned groups over the study period rather than switching participants between strategies. These are general design principles; the registry record does not report the allocation procedure, the identities of the masked roles, or operational details of masking.
The primary endpoint was mean change from baseline in study-eye best-corrected visual acuity at Month 12. The record also lists secondary outcomes concerning leakage and central retinal thickness at Month 12. Although the official title specifies a 24-month study, the primary endpoint described is at Month 12. The registry record does not report numerical primary results, a statistical analysis plan, or details of follow-up beyond the incomplete arm descriptions.
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 | Verteporfin SF + Ranibizumab | Verteporfin RF + Ranibizumab | Ranibizumab Monotherapy |
|---|---|---|---|
| STARTED | 104 | 105 | 112 |
| COMPLETED | 91 | 93 | 102 |
| NOT COMPLETED | 13 | 12 | 10 |
Reasons for not completing this period:
| Reason | Verteporfin SF + Ranibizumab | Verteporfin RF + Ranibizumab | Ranibizumab Monotherapy |
|---|---|---|---|
| Adverse Event | 4 | 3 | 4 |
| Death | 3 | 1 | 3 |
| Lost to Follow-up | 0 | 2 | 0 |
| Protocol Violation | 1 | 0 | 0 |
| Withdrawal by Subject | 5 | 6 | 3 |
Analysis population for the primary outcome, as defined in the registry: The Full analysis set (FAS) consisting of all randomized patients that received at least one application of study drug and had at least one post-baseline assessment for BCVA in the study eye. Last observation carried forward (LOCF) 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 | Verteporfin SF + Ranibizumab | Verteporfin RF + Ranibizumab | Ranibizumab Monotherapy | Total |
|---|---|---|---|---|---|
| Participants analysed | 104 | 105 | 112 | 321 | |
| Age Continuous | years | 77.5 (SD 8.42) | 77.4 (SD 8.48) | 77.2 (SD 7.97) | 77.3 (SD 8.26) |
| Sex: Female, Male: Female | Participants | 64 | 53 | 75 | 192 |
| Sex: Female, Male: Male | Participants | 40 | 52 | 37 | 129 |
6. Primary Endpoint
The registry lists the primary outcome as Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) of the Study Eye at Month 12, measured over Baseline and Month 12.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Letters |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is mean change from baseline in best-corrected visual acuity in the study eye at Month 12, measured in letters. The registry defines the score using the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study visual-acuity chart, assessed at a starting distance of 4 meters. It notes that an ETDRS visual-acuity score of 85 is approximately 20/20 and that an increase in the score indicates improvement in visual acuity.
Visual acuity is a functional measure: it records performance on a standardized reading task rather than describing retinal anatomy alone. A change from baseline expresses how the measured score at follow-up differs from the participant’s starting assessment. Reporting the group mean gives an average change, while the standard deviation describes variation among observations around that average. These are general interpretations of the endpoint’s summary statistics, not results from this trial.
The registry specifies a Full analysis set for this outcome: randomized patients who received at least one application of study drug and had at least one post-baseline study-eye BCVA assessment. It also states that last observation carried forward was used. The record does not report the mean change, its standard deviation, a between-group estimate, or a confidence interval. Consequently, the endpoint definition is available, but the magnitude and precision of the trial’s primary result are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the trial’s primary question and measurement but does not give the primary outcome values. In particular, it does not report the mean change in BCVA for any group, the comparison between combination therapy and ranibizumab monotherapy, or an associated confidence interval or p-value. The primary effect’s direction, magnitude, and statistical precision therefore cannot be assessed from the record. No claim about whether the groups differed on the primary endpoint is warranted from the information reported.
This absence matters because an endpoint definition is not itself an outcome. Knowing that BCVA was scored in ETDRS letters, and that an increase indicates improvement, explains how a result would be interpreted. It does not reveal what values were observed. A treatment comparison would ordinarily require the group summaries and a stated contrast, with uncertainty around that contrast. Those results are not reported in the registry record.
The study description says that visual-acuity and anatomic outcomes, as well as durability of response, were evaluated. The record lists secondary outcomes for change in total leakage area, the percentage of patients with fluorescein leakage, and change in central retinal thickness at Month 12. It does not provide their results. The record also states that there are 5 outcome measures, but it does not provide analysis entries. Thus, neither favorable nor unfavorable conclusions about the listed outcomes can be drawn from these descriptions.
Safety information is reported separately. For serious adverse events, the record gives counts of affected participants and participants at risk for the standard-fluence combination group, reduced-fluence combination group, and monotherapy group. The counts are 32 of 104, 29 of 106, and 41 of 111, respectively. These are descriptive group figures; without a reported comparative analysis, they should not be treated as estimates of a causal difference. The record also gives counts for other adverse events: 85 of 104, 81 of 106, and 87 of 111, respectively. These figures describe reported events or affected participants as represented in the registry fields; they do not supply an adjusted comparison.
Statistical significance and clinical importance are distinct concepts. In general, a p-value addresses how compatible data are with a specified statistical model and null hypothesis, while an interval estimate communicates uncertainty about an effect’s plausible size under that model. Neither can be interpreted without the relevant estimate and analysis details. Because the primary comparison statistics are not reported in the registry record, the evidence’s precision and compatibility with different effect sizes cannot be evaluated.
The enrollment figure describes the study record, not the number included in the primary analysis. The defined Full analysis set has additional eligibility conditions, and the record does not state how many participants met them or how missing assessments affected the endpoint. Enrollment should therefore not be substituted for an analysis denominator. Overall, the registry supports a description of the question, design, endpoint, and some safety counts, but does not provide enough primary efficacy results to characterize the treatment contrast.
9. Statistical Methods Explained
What does a mean change represent?
For a continuous measure such as a visual-acuity score, a mean summarizes the center of the observed values. A mean change from baseline summarizes within-participant changes and then describes their average in the analyzed group. It is not the same as the proportion of participants who improved, because different patterns of individual change can produce the same mean. The registry specifies mean change in BCVA in letters, but does not report the group means or the estimated comparison.
A standard deviation describes how dispersed individual observations are around a group mean. It is not a measure of uncertainty in the estimated mean itself. A confidence interval for a mean or treatment contrast is designed to express sampling uncertainty; its width depends on the variability and amount of information, along with the analysis method. The registry names standard deviation as the endpoint’s dispersion measure, but no standard deviations or confidence intervals are reported for the primary result.
How would a group comparison be interpreted?
A randomized comparison generally focuses on a contrast between outcomes in assigned groups. The estimated contrast describes the observed separation according to the chosen scale, while its uncertainty indicates how precisely that separation is estimated. A p-value, when reported, assesses compatibility with a specified null hypothesis under the statistical model. It does not measure the probability that a treatment is effective, nor does it indicate the importance of an effect by itself. These are general principles. The registry record does not report the primary contrast, its uncertainty, or a p-value.
The primary endpoint is a continuous measure, and the record identifies its summary as a mean with standard deviation. That alone does not identify the precise comparison model. Adjustment variables, assumptions, handling of repeated assessments, and the exact test are not reported in the registry record. It would be inappropriate to infer any of these from the endpoint label or study design.
What is the role of randomization and masking?
Randomization is a design method intended to make assigned groups comparable, on average, with respect to measured and unmeasured characteristics. It does not guarantee identical groups in a particular trial, and it does not remove the need to report baseline data and analysis methods. Masking is intended to limit the influence of knowledge of assignment on behavior or assessment. The registry labels this study randomized and quadruple-masked. It does not describe how the sequence was generated, how assignment was concealed, or which people were masked.
Parallel-group designs retain assigned groups for comparison over the study period. In general, this can support a direct comparison of assigned strategies, provided the analysis and follow-up are appropriately described. Here, the registry identifies a parallel model but does not report enough information to reconstruct the statistical analysis. The arm descriptions also specify different treatment schedules, and are truncated, so the complete procedures cannot be established from the record.
How should missing data be considered?
The primary outcome description specifies last observation carried forward (LOCF). This method uses a participant’s last available assessment to fill a later missing value. It is a missing-data assumption, not a direct observation at the missing visit. Its suitability depends on why measurements are missing and how outcomes would have changed after the last assessment. LOCF can misrepresent uncertainty and can bias results when the assumption that the last value remains an adequate substitute is not plausible. These are general limitations of the method; the registry record does not report missingness patterns or sensitivity analyses for this trial.
The endpoint population is defined as randomized patients who received at least one study-drug application and had at least one post-baseline BCVA assessment in the study eye. This differs conceptually from including every randomized participant regardless of treatment receipt or follow-up. The record does not state the number analyzed, the number excluded, or the amount of missing endpoint data. It also does not report whether any other analysis populations were used.
What can be said about multiplicity and planning?
When several outcomes or comparisons are tested, the chance of at least one nominally significant result can increase unless the analysis accounts for multiplicity. General approaches include prespecifying a primary comparison, adjusting significance thresholds, or interpreting secondary results as exploratory. The registry lists a primary endpoint and secondary outcomes, but does not report a multiplicity strategy or a statistical analysis plan. No adjustment should be assumed.
The registry’s sample-size assumptions describe a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is described as a stated fraction of the observed effect. Such planning calculations are hypothetical illustrations, not observed power and not evidence that the original trial used those assumptions. No numerical planning outputs or trial-specific design justification are reported in the registry record.
The record states that the primary outcome has several categories or time points and was not reduced to one comparison. Without a selected contrast and its results, a single effect estimate cannot be reconstructed. The general statistical ideas above explain what would be needed for interpretation; they do not fill in analyses that the registry record does not report.
10. Multiplicity, Missing Data and Analysis Populations
The registry identifies mean change from baseline in study-eye BCVA at Month 12 as the primary outcome and lists secondary outcomes concerning leakage and central retinal thickness at Month 12. It also records 5 outcome measures and no analysis entries. The record does not report which comparisons were prespecified for each outcome, whether a hierarchy was used, or whether statistical tests were adjusted for multiple comparisons. The multiplicity strategy is therefore not reported in the registry record.
Multiplicity matters because examining several outcomes, time points, or contrasts can increase the chance of finding an apparently notable result through chance alone. This is a general statistical concern, not a claim about what happened in this study. Without the analysis plan and reported results, the strength of evidence across the outcome family cannot be assessed. The record notes that the primary outcome has several categories or time points and was not reduced to one comparison; it does not provide a single primary effect estimate to interpret.
The endpoint description defines the Full analysis set as randomized patients who received at least one application of study drug and had at least one post-baseline study-eye BCVA assessment. It specifies last observation carried forward. The record does not give the number of participants in this analysis set, missing-assessment counts, reasons for missingness, or sensitivity analyses. LOCF is a method for assigning values when follow-up observations are missing; it does not establish that the substituted values reflect what would have been observed.
The registry does not report a statistical analysis plan, an intention-to-treat analysis description, or results from alternative missing-data assumptions. Accordingly, the population definition and LOCF method are known, but the robustness of the primary result to exclusions or missing-data assumptions cannot be evaluated from the registry record.
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 |
|---|---|---|---|
| Verteporfin SF + Ranibizumab | 32 | 104 | 30.8% |
| Verteporfin RF + Ranibizumab | 29 | 106 | 27.4% |
| Ranibizumab Monotherapy | 41 | 111 | 36.9% |
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 |
|---|---|
| Verteporfin SF + Ranibizumab | 85 of 104 |
| Verteporfin RF + Ranibizumab | 81 of 106 |
| Ranibizumab Monotherapy | 87 of 111 |
Most frequent serious adverse event terms
| Event term | Organ system | Verteporfin SF + Ranibizumab | Verteporfin RF + Ranibizumab | Ranibizumab Monotherapy |
|---|---|---|---|---|
| Cardiac failure congestive | Cardiac disorders | 2 of 104 | 2 of 106 | 6 of 111 |
| Pneumonia | Infections and infestations | 2 of 104 | 3 of 106 | 4 of 111 |
| Visual acuity reduced (Study eye) | Eye disorders | 4 of 104 | 1 of 106 | 3 of 111 |
| Myocardial infarction | Cardiac disorders | 1 of 104 | 2 of 106 | 1 of 111 |
| Hip fracture | Injury, poisoning and procedural complications | 2 of 104 | 1 of 106 | 1 of 111 |
| Transient ischaemic attack | Nervous system disorders | 0 of 104 | 1 of 106 | 3 of 111 |
| Atrial fibrillation | Cardiac disorders | 2 of 104 | 0 of 106 | 1 of 111 |
| Bradycardia | Cardiac disorders | 0 of 104 | 0 of 106 | 3 of 111 |
| Endophthalmitis (Study eye) | Infections and infestations | 1 of 104 | 0 of 106 | 2 of 111 |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0 of 104 | 2 of 106 | 1 of 111 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Verteporfin SF + Ranibizumab | Verteporfin RF + Ranibizumab | Ranibizumab Monotherapy |
|---|---|---|---|---|
| Eye pain (Study eye) | Eye disorders | 22 of 104 | 14 of 106 | 14 of 111 |
| Conjunctival haemorrhage (Study eye) | Eye disorders | 13 of 104 | 18 of 106 | 18 of 111 |
| Hypertension | Vascular disorders | 9 of 104 | 13 of 106 | 12 of 111 |
| Nasopharyngitis | Infections and infestations | 10 of 104 | 6 of 106 | 13 of 111 |
| Upper respiratory tract infection | Infections and infestations | 11 of 104 | 10 of 106 | 7 of 111 |
| Choroidal neovascularisation (Fellow eye) | Eye disorders | 7 of 104 | 12 of 106 | 8 of 111 |
| Macular degeneration (Fellow eye) | Eye disorders | 8 of 104 | 6 of 106 | 12 of 111 |
| Retinal haemorrhage (Study eye) | Eye disorders | 7 of 104 | 9 of 106 | 8 of 111 |
| Visual acuity reduced (Study eye) | Eye disorders | 10 of 104 | 9 of 106 | 5 of 111 |
| Nausea | Gastrointestinal disorders | 9 of 104 | 8 of 106 | 7 of 111 |
Serious events with the highest arm-level rate: cardiac failure congestive (5.4%), visual acuity reduced (study eye) (3.8%), pneumonia (3.6%), bradycardia (2.7%), transient ischaemic attack (2.7%).
The registry reports serious adverse event counts and at-risk counts for each listed group. For verteporfin standard fluence plus ranibizumab, 32 of 104 were recorded as affected; for verteporfin reduced fluence plus ranibizumab, 29 of 106; and for ranibizumab monotherapy, 41 of 111. These are descriptive counts. They should be read as registry-reported group data, not as a formal estimate of the treatment effect.
The record also reports other adverse event counts: 85 of 104 for standard-fluence combination therapy, 81 of 106 for reduced-fluence combination therapy, and 87 of 111 for monotherapy. The registry does not provide a statistical comparison or adjusted estimates for these figures. Differences in raw counts alone do not establish that treatment assignment caused a difference in risk. Interpretation can also depend on event definitions, observation time, and how events were collected; those details are not reported in the registry record.
The listed serious-event terms include cardiac failure congestive (5.4%), visual acuity reduced in the study eye (3.8%), pneumonia (3.6%), bradycardia (2.7%), transient ischaemic attack (2.7%), and atrial fibrillation (1.9%). The record does not specify an arm attribution for this list in the reported information. Death counts are not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized, quadruple-masked, parallel-group study compared ranibizumab combined with verteporfin photodynamic therapy against ranibizumab monotherapy in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration. It defines a Month 12 visual-acuity outcome and identifies the analysis population and LOCF method. It also reports group-level safety counts and selected serious-event terms.
Those details do not establish the primary treatment effect. The registry record does not report the mean BCVA change in each group, the estimated comparison, a confidence interval, or a p-value. As a result, the direction and size of the visual-acuity contrast, and the precision with which it was estimated, are unknown from the record. The listed secondary outcomes likewise have no reported results in the information available.
General statistical interpretation distinguishes an observed difference from evidence about its uncertainty and relevance. A point estimate, when available, describes the estimated contrast; a confidence interval indicates uncertainty under an analysis model. A p-value addresses compatibility with a null hypothesis under specified assumptions, rather than the probability that the null is true. No such primary comparison statistics are reported in the registry record, so they cannot be used to support a conclusion about efficacy.
The safety counts are informative as descriptive reports, but they do not by themselves show that one strategy has more or fewer adverse events in a causal sense. The record does not provide comparative safety estimates, adjustment methods, or enough detail to assess differences in exposure and event ascertainment. The serious-event terms and percentages also should not be treated as group-specific without an attribution stated in the record.
Enrollment of 321 is not the same as the number included in the primary analysis. The Full analysis set required treatment receipt and a post-baseline assessment, and its size is not reported. The record also does not give detailed missing-data patterns or sensitivity analyses. Thus, the result’s generalizability and robustness cannot be judged fully from the registry entry. The defensible interpretation is limited to the trial’s stated design, endpoint definition, and reported safety information; conclusions about treatment effects require outcome results that are not reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically notable for comparing a combination strategy with an active monotherapy comparator while identifying a functional, continuous primary endpoint. Mean change in ETDRS letters gives a standardized way to summarize visual-acuity change, and the registry explains the direction of the score. The design also distinguishes standard-fluence and reduced-fluence photodynamic therapy in the listed combination groups. These features make clear what the study set out to compare, even though the primary outcome results are not reported in the registry record.
Its record also illustrates why endpoint definitions and analysis results must be read separately. The endpoint specifies the measure, assessment timing, population criteria, and LOCF approach. Those details clarify how the outcome was intended to be summarized, but they do not provide the estimated effect or its precision. Without group summaries and a comparison, readers cannot evaluate whether the observed data were compatible with a range of possible treatment effects.
The study’s multiple outcomes make the analysis plan relevant. The registry lists secondary anatomic outcomes and says the primary outcome has several categories or time points, but does not report the multiplicity strategy or a single primary comparison result. General statistical practice treats prespecification and multiplicity handling as important for distinguishing confirmatory questions from exploratory ones. The record does not permit that distinction to be fully assessed.
The entry also provides a practical example of interpreting safety summaries cautiously. Counts and percentages describe reported events, but do not substitute for comparative estimates or detail on exposure and event collection. Likewise, a planning illustration based on an observed effect is not the same as the original design justification or observed power. The registry states assumptions for such an illustration, while the trial-specific design rationale is not reported.
Overall, the study matters as a clearly identified randomized comparison with an explicitly defined visual-acuity endpoint, but its statistical conclusions cannot be reconstructed from the registry record alone. That distinction between design information and reported evidence is central to transparent clinical-trial interpretation.
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 this trial from the registry record is the absence of primary outcome results. There are no reported group means, standard deviations, treatment-effect estimates, confidence intervals, or p-values for the Month 12 BCVA endpoint. The direction, magnitude, and precision of the primary comparison are therefore unavailable. Results for the listed secondary outcomes are also not reported.
The record states that the primary outcome has several categories or time points and was not reduced to one comparison. It does not identify a specific contrast or provide an analysis plan that would explain how the primary question was handled. The multiplicity approach is not reported. This prevents assessment of how outcome selection and multiple testing were addressed.
The primary analysis population is defined, but its size is not reported. The record does not give counts for participants excluded from that population, missing BCVA assessments, or reasons for missingness. LOCF is specified, but no sensitivity analyses are reported to show whether the result would be robust to different assumptions. The registry also does not describe the statistical model, covariate adjustment, or handling of repeated assessments.
The treatment descriptions are truncated, limiting interpretation of the complete treatment and retreatment schedules. The registry identifies quadruple masking but does not explain which roles were masked or how masking was maintained. Baseline characteristics and detailed follow-up information are not reported in the registry record for this record.
Safety counts are available, but comparative analyses, event-collection details, and exposure-adjusted results are not reported. Death counts are not reported in the registry record. The listed serious-event terms lack stated group attribution in the information available. These limitations mean the safety figures should be treated as descriptive rather than as definitive comparative evidence.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Efficacy/Safety of Verteporfin Photodynamic Therapy and Ranibizumab Compared With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization — NCT00436553.
- Registry record last updated 2011-04-19; status last verified 2011-03.
- 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
NCT00436553 is a completed randomized, quadruple-masked, parallel-group Phase IIIB study sponsored by Novartis. The official title describes a 24-month comparison of verteporfin photodynamic therapy with ranibizumab versus ranibizumab monotherapy in subfoveal choroidal neovascularization secondary to age-related macular degeneration. Enrollment was 321; the recorded start was 2007-02 and primary completion was 2009-10.
The primary endpoint was mean change from baseline in study-eye BCVA at Month 12, measured in ETDRS letters. The record defines the Full analysis set and specifies LOCF, but does not report the primary outcome results or a treatment-effect estimate. Secondary outcomes concern leakage and central retinal thickness; their results are not reported in the registry record.
Serious and other adverse-event counts are reported by group, along with selected serious-event terms. No comparative safety analysis or death counts are reported in the registry record. Overall, the entry describes the design and outcome definitions but does not provide the efficacy statistics needed to interpret the primary comparison.