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 And Safety Of Macugen In Patients With Neovascular AMD In Routine Clinical Practice. (NCT00858208), a registered phase not stated study. The primary outcome is Change From Baseline Visual Acuity (VA) at the Final Visit.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00858208 |
| Phase | Phase not stated |
| Condition | Neovascular Age-related Macular Degeneration |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 86 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Pfizer |
| Results posted | Yes |
2. Clinical Question
Population
Participants with neovascular age-related macular degeneration enrolled in a study conducted under conditions of routine clinical practice. The record states an enrollment of 86 and defines the analysis population as enrolled participants who received at least 1 dose of pegaptanib and had evaluable data for the measure being analyzed.
Intervention
Pegaptanib sodium, identified in the record as the drug intervention and described elsewhere as MACUGEN. The study was non-interventional; the record does not describe a treatment assignment procedure.
Comparator
No like-for-like control group is described. The record states that allocation was not stated and that this is not a randomized comparison. The listed study group is not a control arm against which a causal treatment contrast can be estimated.
Primary question
What was the mean change in visual acuity from baseline to the final visit, measured in logMAR, among participants with evaluable data? The intended final assessment was at Week 102 or early termination. The numerical result is not reported in the registry record.
The study concerns visual acuity in routine practice rather than a randomized comparison of treatments. Visual acuity could be assessed using the Early Treatment Diabetic Retinopathy Study chart, a Snellen chart, or other methods that verified whether a participant could count fingers, perceive hand motion, or perceive light. The endpoint translates those assessments into logMAR scores and compares the final score with the baseline score.
The central statistical question is descriptive: what average within-participant change was recorded among those with evaluable measurements? A negative change on the stated scale represents improvement in visual acuity, but the registry record does not give the mean change, its standard deviation, or the number of participants contributing evaluable data to the primary analysis. It therefore does not establish the size or precision of the observed change. Nor does a before-and-after result from this design, even if available, by itself isolate the effect of pegaptanib from other influences in routine practice.
3. Trial Design
This was a completed, long-term, non-interventional study of pegaptanib sodium in people with neovascular age-related macular degeneration under conditions of routine clinical practice. Its stated purpose was to investigate efficacy and safety in that setting. The registry record identifies Pfizer as the sponsor, an enrollment of 86, a start date of 2008-03, and a primary completion date of 2011-04. The listed status is COMPLETED.
The record lists a group of patients with neovascular age-related macular degeneration and an intervention of pegaptanib sodium. It does not describe a randomized allocation, and it explicitly cautions that this is not a randomized comparison and that the arms are not a like-for-like control comparison. Allocation is not stated. Consequently, the record does not support treating any listed groups as exchangeable treatment and control arms or interpreting a between-group contrast as a randomized treatment effect.
The primary outcome is change from baseline visual acuity at the final visit. The stated timeframe is baseline to Week 102 or early termination. Visual acuity was measured using the Early Treatment Diabetic Retinopathy Study chart, a Snellen chart, or other methods verifying whether the participant could count fingers, perceive hand motion, or light. The measure is expressed in logMAR.
Other registered outcomes include change from baseline visual acuity at each visit, visual-acuity change at the final visit for participants with vascular retinal pigment epithelial detachment, and change from baseline NEI-VFQ-25 overall composite and sub-scale scores. The registry record lists 14 outcome measures and 22 analyses, but does not describe how the analyses were selected or prioritized beyond identifying the primary outcome. The primary analysis population is defined as the Safety Analysis Set, also called the Full Analysis Set, consisting of enrolled participants who received at least 1 dose of pegaptanib; the number analyzed is defined by evaluable data.
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 | Pegaptanib |
|---|---|
| STARTED | 85 |
| COMPLETED | 6 |
| NOT COMPLETED | 79 |
Reasons for not completing this period:
| Reason | Pegaptanib |
|---|---|
| Adverse Event | 3 |
| Lost to Follow-up | 26 |
| Participant refused | 40 |
| Other | 10 |
Analysis population for the primary outcome, as defined in the registry: Safety Analysis Set (SAS) = Full Analysis Set (FAS): Enrolled participants who received at least 1 dose of Pegaptanib; Number of participants analyzed (N)=participants with evaluable data
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 | Pegaptanib |
|---|---|---|
| Participants analysed | 85 | |
| Age Continuous | years | 74.0 (SD 6.8) |
| Sex: Female, Male: Female | Participants | 44 |
| Sex: Female, Male: Male | Participants | 41 |
| National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) sub-scale scores at baseline: General Health (n=85) | scores on a scale | 45.00 (SD 23.081) |
| National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) sub-scale scores at baseline: General Vision (n=85) | scores on a scale | 55.53 (SD 16.439) |
| National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) sub-scale scores at baseline: Ocular Pain (n=85) | scores on a scale | 80.74 (SD 20.912) |
| National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) sub-scale scores at baseline: Near Activities (n=85) | scores on a scale | 53.09 (SD 28.976) |
| National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) sub-scale scores at baseline: Distance Activities (n=85) | scores on a scale | 58.73 (SD 28.264) |
| National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) sub-scale scores at baseline: Social Functioning (n=85) | scores on a scale | 72.35 (SD 28.809) |
| National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) sub-scale scores at baseline: Mental Health (n=85) | scores on a scale | 50.51 (SD 24.056) |
| National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) sub-scale scores at baseline: Role Difficulties (n=85) | scores on a scale | 57.06 (SD 31.425) |
| National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) sub-scale scores at baseline: Dependency (n=85) | scores on a scale | 61.27 (SD 28.542) |
| National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) sub-scale scores at baseline: Driving (n=30) | scores on a scale | 49.72 (SD 35.523) |
| Procedures used for age-related macular degeneration (AMD) diagnosis: fluorescein angiography | participants | 66 |
| Procedures used for age-related macular degeneration (AMD) diagnosis: indocyanine green angiography | participants | 0 |
| Procedures used for age-related macular degeneration (AMD) diagnosis: optical coherence tomography | participants | 18 |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline Visual Acuity (VA) at the Final Visit, measured over Baseline, Week 102 or Early Termination (ET).
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | logMAR |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the change from baseline in visual acuity at the final visit, expressed in logMAR. The registry defines change as the visual-acuity score at a visit minus the baseline score. On this scale, a negative change represents improvement in visual acuity. The stated endpoint timeframe is baseline to Week 102 or early termination.
Visual acuity is a direct measure of visual performance, and a baseline-to-follow-up change provides a way to describe how the measure varied over the period of observation. The registry permits several assessment methods: the Early Treatment Diabetic Retinopathy Study chart, a Snellen chart, or other methods verifying whether a participant could count fingers, perceive hand motion, or light. The score is transformed to logMAR, with the stated range from 0, representing 20/20 vision, to 1.
The endpoint is summarized as a mean, with standard deviation as the dispersion measure. The mean describes the average change among participants with evaluable data; the standard deviation describes variation in individual changes around that mean. Neither statistic, by itself, indicates how precisely the mean is estimated. That precision would ordinarily be assessed using an interval estimate, but the numerical mean, standard deviation, and interval estimate are not reported in the registry record.
Because the endpoint compares follow-up with baseline in a non-interventional study, it describes change over time in the analyzed participants. It does not, on its own, separate a treatment effect from changes that could occur with time, patient characteristics, clinical decisions, or other influences. The record does not provide a control comparison to address those alternatives.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a clinically interpretable primary measure: mean change in visual acuity from baseline to the final visit, on the logMAR scale. It also defines the direction of change, with a negative value representing improvement. These definitions make clear what a numerical estimate would mean, but the numerical primary result is not reported in the registry record. The mean change, standard deviation, and number analyzed are therefore unavailable for interpretation from this record.
Without an estimate and a measure of its precision, readers cannot determine the magnitude of the average observed change or how much uncertainty surrounds it. A confidence interval, if reported, would show a range of values compatible with the data and analysis under its assumptions; it would not guarantee that the true value lies within that range. No confidence interval or other precision estimate for the primary outcome is reported in the registry record. A p-value for the primary outcome is also not reported.
The design matters for interpretation. This was a non-interventional study in routine clinical practice, and the record states that it is not a randomized comparison. The listed allocation is not stated, and the record cautions that the arms are not a like-for-like control comparison. A change between baseline and the final visit would therefore describe the observed course of participants with evaluable data, not a randomized contrast with an untreated or alternative-treatment group. Even a clearly estimated within-participant change could not by itself establish that pegaptanib caused that change.
The record’s brief summary frames the study as investigating efficacy and safety in routine practice and refers to results at least as good as those demonstrated in randomized multicenter trials. That statement is a summary of the study’s stated purpose, not a numerical result. The registry record does not report the primary endpoint estimate needed to assess that assertion, and it does not provide a comparator or an analysis that would establish equivalence or non-inferiority to another study or treatment.
The other registered outcomes broaden the scope beyond visual acuity. They include visual-acuity change at visits, a final-visit analysis for participants with vascular retinal pigment epithelial detachment, and NEI-VFQ-25 overall composite and sub-scale scores. However, the numerical results for these outcomes are not reported in the registry record. Their presence in the outcome list should not be mistaken for evidence about their direction, size, or precision.
In short, the record specifies the intended measure, scale, population definition, and follow-up window, but not the outcome values. Statistical interpretation must remain limited to those design and measurement details. No conclusion about the observed amount of visual-acuity change or its uncertainty can be drawn from the results information recorded.
9. Statistical Methods Explained
The primary outcome is a continuous measure, and the registry identifies the summary statistic as a mean with standard deviation. In general, a mean is the arithmetic average of observed values. For this endpoint, the values are participant-level changes from baseline in logMAR visual acuity. The standard deviation describes how dispersed those changes are around the mean; it is not the uncertainty of the mean itself. Precision of the mean is more directly conveyed by a confidence interval or standard error. Neither an estimate of the mean nor a numerical estimate of its precision is reported in the registry record.
What does the change score represent?
The record defines change as the visual-acuity score at a visit minus the baseline score. This means the outcome is a within-participant difference between two measurements, rather than the follow-up score considered alone. The scale definition is important to interpretation: negative change represents improvement in visual acuity, while the record states that logMAR ranges from 0, representing 20/20 vision, to 1. The endpoint’s specified timeframe is baseline to Week 102 or early termination.
In general, change scores can account for each participant’s starting measurement when describing subsequent movement. They do not remove all uncertainty or all possible sources of bias. Their interpretation depends on the quality and availability of baseline and follow-up measurements, the outcome scale, and the analysis population. The registry allows several methods of assessing acuity, including the Early Treatment Diabetic Retinopathy Study chart and Snellen chart, as well as verification of counting fingers, hand motion, or light perception. The record does not describe how differences among these assessment methods were handled in analysis.
What does the analysis population mean?
The registry defines the Safety Analysis Set as the Full Analysis Set: enrolled participants who received at least 1 dose of pegaptanib. For each outcome, the number analyzed is defined as the participants with evaluable data. These statements distinguish the population definition from the actual number contributing to a particular result. The numerical number analyzed for the primary endpoint is not reported in the registry record. The enrollment figure of 86 should not be treated as the denominator for every outcome, because the record defines outcome-specific analysis counts by evaluable data and does not state those counts.
As a general statistical point, restricting an analysis to participants with evaluable outcome data can affect interpretation if missingness is related to health status, treatment experience, or the measured outcome. The amount and pattern of missing primary-outcome data, and the assumptions or methods used to address missing data, are not reported in the registry record. It is therefore not possible to assess whether the evaluable-data analysis might differ from an analysis of all enrolled participants.
How should precision be understood?
In general, a confidence interval combines an estimate with information about its sampling uncertainty. A narrower interval indicates greater statistical precision under the assumptions used to construct it, while a wider interval indicates less precision. Precision is distinct from clinical importance: an estimate can be precise without being important, and an imprecise estimate may leave a broad range of possible effects. The registry record does not report a confidence interval for the primary mean change, so neither the range of compatible values nor the precision of the estimate can be assessed.
Standard deviation and confidence interval answer different questions. Standard deviation describes spread among participant measurements. A confidence interval describes uncertainty about an estimated quantity, such as a population mean. The registry names standard deviation as the dispersion measure but does not provide its value. It also does not report the primary mean, so no recalculation from posted summary statistics is available in this record.
What do the planning assumptions indicate?
In general, a sample-size planning calculation estimates the number of participants needed to detect a specified effect under stated assumptions. The planning assumptions associated with this study describe an illustration based on a fraction of the observed effect, a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. These are planning assumptions, not evidence that the study used a randomized two-arm design. The registry describes a non-interventional study and does not state allocation.
Such planning figures are conditional on their assumptions and are not observed power. Power is a design quantity associated with a specified effect and analysis; it cannot be inferred as a post-study measure of whether a result is convincing. The actual observed effect and any numerical planning outputs are not reported in the registry record. The record also does not report a sample-size justification for the study’s own design. Accordingly, the planning assumptions do not establish that the enrollment was adequate for the primary outcome or that a particular result would have been detected.
Why can over-dispersion matter in general?
Over-dispersion is a general concern for count outcomes when the observed variation exceeds what a chosen statistical model expects. A model that understates variation can make uncertainty appear smaller than it is. The primary outcome in this study is a continuous change score summarized by a mean and standard deviation, not a count endpoint, so over-dispersion is not the central issue for interpreting the primary measure. The registry record does not describe a statistical model or variance adjustment for the primary analysis. No model-specific inference can therefore be attributed to the study from the record.
10. Multiplicity, Missing Data and Analysis Populations
The registry records 14 outcome measures and 22 analyses, with a primary visual-acuity outcome and several secondary outcomes. The listed secondary outcomes include visual-acuity change at each visit, final-visit visual-acuity change for participants with vascular retinal pigment epithelial detachment, and changes in NEI-VFQ-25 overall composite and sub-scale scores. Considering multiple outcomes or analyses can raise the chance of obtaining apparently notable results by chance if results are selected or interpreted without accounting for the number of comparisons. In general, multiplicity can be handled through prespecified outcome hierarchies, adjustment procedures, or cautious interpretation of exploratory findings.
The registry record does not report a multiplicity adjustment, a hierarchy among secondary outcomes, or which analyses were prespecified beyond identifying the primary outcome. It also does not report numerical results for the primary or secondary outcomes. The existence of multiple listed analyses does not reveal whether adjustment was used, and no conclusion about statistical significance across outcomes can be made from the record.
The analysis population is defined as enrolled participants who received at least 1 dose of pegaptanib, with the number analyzed determined by evaluable data. Outcome-specific analyzed counts are not reported in the registry record. The record does not describe the amount or pattern of missing data, reasons for missing measurements, imputation, sensitivity analyses, or assumptions about missingness. These omissions limit assessment of how representative the analyzed participants are of the population defined for the study and how missing measurements might affect estimates.
The registry’s distinction between the Safety Analysis Set and Full Analysis Set is stated as an equivalence in the population definition. It does not provide enough detail to assess additional analysis sets or deviations from that definition. No inference about missing-data handling or multiplicity procedures should be made in the absence of a reported method.
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 |
|---|---|---|---|
| Pegaptanib | 1 | 85 | 1.2% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Pegaptanib | 5 of 85 |
Most frequent serious adverse event terms
| Event term | Organ system | Pegaptanib |
|---|---|---|
| Intestinal polyp | Gastrointestinal disorders | 1 of 85 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Pegaptanib |
|---|---|---|
| Retinal tear | Eye disorders | 1 of 85 |
| Uveitis | Eye disorders | 1 of 85 |
| Asthenia | General disorders | 1 of 85 |
| Systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | 1 of 85 |
| Dizziness | Nervous system disorders | 1 of 85 |
| Rash | Skin and subcutaneous tissue disorders | 1 of 85 |
Serious events with the highest arm-level rate: intestinal polyp (1.2%).
The registry lists 85 participants at risk for the serious adverse-event figure and 1 affected. For the other reported adverse-event figure, it lists 85 at risk and 5 affected. These counts should be read as the posted figures for this study, not as comparative estimates against another treatment or a control group. The record does not describe a like-for-like control comparison, so the figures cannot establish whether event occurrence differed because of treatment.
The most frequent serious-event term listed is Intestinal polyp, reported as 1.2%. That term and percentage describe what the registry lists; the record does not provide additional clinical detail about the event, its timing, severity beyond its serious classification, or relationship to treatment. The death figure is not reported in the registry record.
In general, adverse-event counts depend on how events were defined, collected, and coded, as well as the period of observation. Those collection and coding details are not reported. The at-risk counts are not necessarily the denominator for every outcome or analysis in the study; the registry lists them specifically with the adverse-event figures. These data describe reported events in the study and do not, on their own, establish causation or comparative safety.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a non-interventional study was conducted in routine clinical practice to investigate pegaptanib sodium in people with neovascular age-related macular degeneration. It specifies a primary outcome of mean change in visual acuity from baseline to the final visit, measured in logMAR, and defines negative change as improvement. It also identifies Week 102 or early termination as the intended final assessment. These details clarify what the outcome was meant to capture.
The record does not report the primary endpoint result, its standard deviation, the number analyzed, or a confidence interval. It therefore does not show the observed size of visual-acuity change or the precision of an estimate. The registry’s brief summary describes the study’s aim in relation to results demonstrated in randomized multicenter trials, but the recorded information does not permit that claim to be evaluated through a reported numerical outcome or a direct comparison.
The design limits causal interpretation. This was not a randomized comparison, allocation was not stated, and the record cautions that the arms are not a like-for-like control comparison. Any observed baseline-to-follow-up change would describe participants over time; without an appropriate comparison, it could not isolate the effect of pegaptanib from other explanations for change.
The safety figures report affected participants and a serious-event term, but they are not comparative evidence and do not establish that an event was caused by treatment. Missing-data procedures, outcome multiplicity procedures, and detailed statistical methods are not reported in the registry record. Those omissions further constrain assessment of the results.
Thus, the record supports a description of the study question, design, measurement approach, analysis-population definition, and selected safety counts. It does not provide the numerical efficacy results needed to characterize the magnitude, direction, or precision of the primary outcome. No conclusion about treatment benefit, lack of benefit, equivalence, or comparative safety follows from the information recorded.
13. Why This Trial Matters Statistically
This study is statistically relevant because it asks how a clinical outcome was measured and described in routine practice, outside a randomized comparison. Routine-practice data can address questions about outcomes in the setting where care occurs, but the interpretation depends strongly on who was included, how measurements were obtained, and what comparisons are available. The registry identifies the setting as non-interventional and does not describe randomized allocation, making clear that causal claims require particular caution.
The primary outcome also illustrates why scale and direction must be reported explicitly. The endpoint is a change score in logMAR, and the record states that negative change represents improvement. Without that definition, the sign of an estimate could be misread. The record additionally permits more than one visual-acuity assessment method, so interpretation of a numerical result would benefit from information about consistency and handling of those methods. Such handling is not reported in the registry record.
The analysis-population definition and evaluable-data rule matter because enrollment alone does not tell readers how many observations contribute to a particular endpoint. The record defines the relevant population and explains that the analyzed number depends on evaluable data, but does not report the primary analyzed count or missing-data methods. This leaves important questions about precision and potential selection effects unresolved.
Finally, the record lists multiple outcomes and analyses without reporting a multiplicity strategy or numerical outcome results. That combination makes it especially important to distinguish the intended study question from evidence that can be evaluated statistically. The registry contributes useful design and measurement information, while the absence of reported endpoint estimates prevents an assessment of the observed effect and its uncertainty.
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 principal limitation for interpreting the primary outcome is that its numerical result is not reported in the registry record. The record specifies the measure and analysis approach as a mean with standard deviation, but gives no mean change, standard deviation, analyzed count, or confidence interval. The magnitude and precision of the observed outcome therefore cannot be assessed.
The non-interventional design and absence of a like-for-like control comparison restrict causal interpretation. Allocation is not stated, and the record cautions that this is not a randomized comparison. The study can be understood as an investigation in routine clinical practice, but the record does not support attributing a within-participant change specifically to pegaptanib.
The primary measure could be assessed using the Early Treatment Diabetic Retinopathy Study chart, a Snellen chart, or other methods involving verification of visual abilities such as counting fingers, perceiving hand motion, or perceiving light. The record does not report how different measurement methods were harmonized or analyzed. It also does not report the completeness of outcome collection, the extent or pattern of missing data, or methods for handling missing measurements.
The registry lists multiple outcomes and analyses but does not report a multiplicity procedure or a hierarchy for interpreting secondary outcomes. Numerical results for the listed secondary outcomes are also not reported. The adverse-event figures include affected counts and a serious-event term, but the record does not provide comparative safety data or detailed information on event ascertainment and attribution. Finally, the record does not report a sample-size justification for the study’s own design or a statistical analysis plan. These limitations leave both effect estimation and the assessment of analysis choices incomplete.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Efficacy And Safety Of Macugen In Patients With Neovascular AMD In Routine Clinical Practice. — NCT00858208.
- Registry record last updated 2012-04-11; status last verified 2011-09.
- Results first posted 2012-04-11.
- 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
NCT00858208 is a completed, non-interventional study of pegaptanib sodium in neovascular age-related macular degeneration under conditions of routine clinical practice. The registry lists an enrollment of 86, Pfizer as sponsor, a start date of 2008-03, and a primary completion date of 2011-04.
The primary outcome is mean change from baseline visual acuity at the final visit, measured in logMAR, with a timeframe of baseline to Week 102 or early termination. Negative change represents improvement. The analysis population is defined as enrolled participants who received at least 1 dose, with the analyzed number based on evaluable data.
The record describes no randomized comparison and states that allocation is not stated. It lists serious adverse-event figures of 1 affected among 85 at risk and other adverse-event figures of 5 affected among 85 at risk; Intestinal polyp is listed as a serious-event term at 1.2%. The numerical primary efficacy result and its precision are not reported in the registry record.