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 Clinical Study to Investigate Safety and Efficacy of GSK933776 in Adult Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration (NCT01342926), a randomized phase 2 study. The primary outcome is Change From Baseline in the Area of Geographic Atrophy (GA) Assessed by Color Fundus Photographs (FP) in the Study Eye.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01342926 |
| Phase | Phase 2 |
| Condition | Atrophy, Geographic |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 191 |
| Arms in the primary outcome | n/a |
| Lead sponsor | GlaxoSmithKline |
| Results posted | Yes |
2. Clinical Question
Population
Adults with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The primary-outcome population is described as an efficacy population, with protocol criteria concerning GA area and repeated visit data. Participants who developed choroidal neovascularization (CNV) in the study eye during treatment were excluded from that population.
Intervention
GSK933776 administered by intravenous infusion. The registry lists dose groups of 3 mg/kg, 6 mg/kg and 15 mg/kg.
Comparator
Placebo administered by intravenous infusion. The study is described as placebo-controlled and parallel-group.
Primary question
How did the area of GA in the study eye, assessed from color fundus photographs, change from baseline at the specified follow-up visits in the study groups? The registry identifies change from baseline as the primary endpoint, but the endpoint estimates and between-group comparisons are not reported in the registry record.
The study was intended to investigate the safety and efficacy of GSK933776 in adults with GA secondary to AMD. Its primary outcome focuses on the measured area of atrophy in the study eye, rather than on visual acuity or a patient-reported measure. The registry also lists secondary outcomes involving GA area assessed using fundus autofluorescence, visual-acuity changes and losses of ETDRS letters, as well as pharmacokinetic measures of GSK933776.
The clinical question is therefore about whether the measured progression of GA differed across the dose groups and placebo over follow-up. The registry record identifies the outcome and study design, but it does not report the primary estimates or the statistical comparison needed to describe the size and precision of any between-group differences.
3. Trial Design
NCT01342926 is a completed phase 2 study sponsored by GlaxoSmithKline. The registry describes it as randomized, quadruple-masked and parallel-group, with placebo control. Enrollment is listed as 191. The study began on 2011-06-01, and primary completion is listed as 2016-04-01.
Participants were assigned to GSK933776 dose groups or placebo. The intervention descriptions specify intravenous infusions of GSK933776 at 3 mg/kg, 6 mg/kg or 15 mg/kg, and an intravenous placebo infusion. A randomized design is intended to reduce systematic differences between groups at allocation. Masking is intended to limit the influence of expectations on care, assessments or reporting; the registry does not specify in the information which roles were masked.
The parallel-group structure means the listed groups were studied as separate treatment groups rather than as a crossover sequence. The primary endpoint is change from baseline in GA area in the study eye, assessed by color fundus photographs. Assessments are listed at baseline, 6 months, 12 months and 18 months. The registry describes a 90% confidence interval as the endpoint’s dispersion measure.
The primary efficacy population is narrower than a simple description of all enrolled participants. It is defined using protocol criteria for GA area, follow-up data availability and exclusion of participants who developed CNV in the study eye during treatment. The registry notes that only participants available at the specified time points were analyzed for the primary outcome. It does not report the allocation sequence method, concealment procedures, infusion schedule details or a full statistical analysis plan; those details 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: The total duration of participation was approximately 25 months following screening.
Overall Study
| Stage | Placebo | GSK933776 (3 mg/kg) | GSK933776 (6 mg/kg) | GSK933776 (15 mg/kg) |
|---|---|---|---|---|
| STARTED | 46 | 46 | 48 | 51 |
| COMPLETED | 37 | 31 | 34 | 39 |
| NOT COMPLETED | 9 | 15 | 14 | 12 |
Reasons for not completing this period:
| Reason | Placebo | GSK933776 (3 mg/kg) | GSK933776 (6 mg/kg) | GSK933776 (15 mg/kg) |
|---|---|---|---|---|
| Adverse Event | 5 | 8 | 10 | 7 |
| Lost to Follow-up | 0 | 1 | 1 | 0 |
| Investigator Discretion | 2 | 2 | 0 | 0 |
| Withdrawal by Subject | 2 | 4 | 3 | 5 |
Analysis population for the primary outcome, as defined in the registry: Efficacy Population. Participants who developed CNV in the study eye during the treatment period are excluded from Efficacy Population per protocol.
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 | Placebo | GSK933776 3 mg/kg | GSK933776 6 mg/kg | GSK933776 15 mg/kg | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 46 | 46 | 48 | 51 | 191 | |
| Age, Continuous | Years | 75.3 (SD 9.55) | 77.2 (SD 9.09) | 77.5 (SD 8.57) | 78.6 (SD 7.22) | 77.2 (SD 8.63) |
| Sex: Female, Male: Female | Participants | 27 | 29 | 26 | 27 | 109 |
| Sex: Female, Male: Male | Participants | 19 | 17 | 22 | 24 | 82 |
| Race/Ethnicity, Customized: African American/African Heritage | Participants | 1 | 0 | 0 | 0 | 1 |
| Race/Ethnicity, Customized: White | Participants | 45 | 46 | 48 | 51 | 190 |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline in the Area of Geographic Atrophy (GA) Assessed by Color Fundus Photographs (FP) in the Study Eye, measured over Baseline (BL), 6 months, 12 months and 18 months.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 90% Confidence Interval |
| Unit | square millimeter (m^2) |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is change from baseline in the area of GA in the study eye, assessed from color fundus photographs. The registry gives the unit as square millimeter (m^2) and lists assessments at baseline, 6 months, 12 months and 18 months. Change is defined as the value at the relevant visit minus the baseline value. The registry also notes that screening occurs before baseline.
GA involves atrophic changes in the retina and underlying tissues in the macula. Measuring its area provides a structural measure of the affected region. Repeating the measurement over follow-up can describe how the measured area changes over time. Comparing changes between randomized groups can help assess whether their observed patterns differ, subject to the quality and completeness of the measurements and the analysis used.
The endpoint is not itself a direct measure of visual function. The registry lists visual-acuity outcomes separately, including ETDRS best-corrected visual acuity. It also lists secondary GA-area outcomes assessed using fundus autofluorescence images, a distinct imaging measure from the color fundus photographs named for the primary endpoint.
The registry identifies the endpoint and its 90% confidence interval, but does not report the group estimates, interval limits or between-group contrasts. Accordingly, the magnitude, direction and precision of the primary outcome cannot be described from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies a randomized, placebo-controlled comparison of GSK933776 dose groups with placebo and names change in GA area as the primary endpoint. However, the primary endpoint estimates and between-group results are not reported in the registry record. There is therefore no basis in the posted information for describing whether the groups differed, how large any difference was, or how precisely it was estimated.
The endpoint is a change score: the measurement at a follow-up visit minus the baseline measurement. A negative or positive change would need to be interpreted according to the measurement convention and the actual reported values. Those values are absent from the registry information available for this analysis. It would not be appropriate to infer a result from the study title, the stated purpose, its completion status or the presence of an endpoint definition.
The registry specifies a 90% confidence interval as the dispersion measure for the primary outcome. In general, a confidence interval communicates the uncertainty around an estimate under the assumptions of the analysis. A narrower interval indicates greater precision than a wider interval, but interpretation also depends on the estimate, the scale and the clinical context. Since neither the interval limits nor the estimates are reported, the precision of the primary results cannot be assessed.
The registry lists multiple follow-up times for the primary endpoint and multiple secondary outcomes, including imaging, visual acuity and pharmacokinetic measures. Results for those outcomes are not included in the registry record for this analysis. It is also not reported in the registry record whether any formal between-group test was conducted for each time point, whether repeated measures were modeled jointly, or how multiplicity across outcomes and time points was handled.
Enrollment is listed as 191, but enrollment alone does not establish the number of participants contributing data at a particular visit or to the efficacy analysis. The registry says that only participants available at a specified time point were analyzed and describes additional criteria for the efficacy population. Visit-specific analysis counts and the flow of participants into the primary analysis are not reported in the registry record.
The safety information gives counts of participants with serious and other adverse events in each listed group, alongside group counts at risk. These are descriptive summaries; no adjusted comparisons, uncertainty intervals or formal safety tests are reported in the registry information. The listed serious-event terms have percentages, but the registry entries do not state their analytic denominator or provide a group-specific breakdown for those terms. These limitations mean that the safety counts should not be treated as a complete comparative estimate of risk.
Overall, the record describes a relevant randomized design and a structural primary outcome, but it does not contain the primary efficacy results needed to judge the observed differences or their uncertainty. The registry’s study purpose is not evidence of an observed effect.
9. Statistical Methods Explained
The registry describes random allocation, masking and a parallel-group comparison. These design features concern how treatment groups are formed and how knowledge of assignment may influence conduct or measurement. They do not, by themselves, specify the statistical model used to estimate the primary outcome. The particular allocation procedure, masking roles and analysis model are not reported in the registry record.
What does change from baseline mean?
The primary measure is calculated as a follow-up GA-area value minus the baseline value. This makes the estimate a change score rather than a follow-up measurement alone. The registry lists baseline and follow-up assessments at 6 months, 12 months and 18 months. Screening is described as occurring before baseline, and the endpoint definition distinguishes screening from the baseline value.
In general, analyzing change from baseline can account for each participant’s starting measurement, but the interpretation depends on how measurements are collected and how the analysis handles baseline values and missing follow-up data. The registry does not report whether the primary comparison used a model adjusting for baseline, a direct comparison of change scores, or another approach. It also does not report how correlations among repeated measurements were handled.
What does the confidence interval convey?
The primary endpoint lists a 90% confidence interval. In general, a confidence interval describes the statistical uncertainty around an estimate under a specified method and its assumptions. It is not a guarantee that the true value lies within the particular interval, and it does not by itself indicate whether an estimated difference is important in clinical terms. The primary estimate and interval limits are not reported in the registry record, so their width and the precision of the comparison cannot be evaluated.
Why can repeated measurements be challenging?
When measurements are made repeatedly on the same participant, observations are generally related rather than independent. In general, an analysis that accounts for this dependence can use the repeated data appropriately and estimate change over time. A method that treats correlated measurements as independent may give misleading uncertainty. The registry information does not identify a repeated-measures model or describe any other method for addressing within-participant correlation.
The outcome is an area measured from images. In general, imaging outcomes can be affected by measurement variability, image quality and assessment procedures. Masking may help reduce some assessment biases, but the registry information does not describe image-reading procedures, reader agreement, adjudication or quality-control methods. Those measurement details are not reported in the registry record.
What do the analysis-population criteria imply?
The primary endpoint is described for an efficacy population. Its definition includes protocol criteria for GA area, a requirement for data across a specified share of visits from post-baseline treatment month 2 through treatment month 19, and exclusion of participants who developed CNV in the study eye during treatment. The stated repeated-visit criterion is at least 75% of visits, identified as at least 14 visits. These criteria mean the primary efficacy population is not necessarily identical to everyone enrolled or randomized.
The registry also says that only participants available at a specified time point were analyzed for that time point. In general, analyzing available observations can result in different participant sets at different visits. If the reasons for missing measurements relate to outcomes or treatment, estimates based only on observed data may be affected. The registry does not report the amount or reasons for missing primary-outcome data, the method used to address missingness, or sensitivity analyses.
How should planning illustrations be understood?
In general, a sample-size calculation based on an observed effect is a planning illustration, not evidence that the completed trial had a particular probability of detecting an effect. The registry’s planning assumptions describe a two-sided significance level of 0.05, equal allocation between two arms and a normal approximation, with planning scenarios based on fractions of an observed effect. Those assumptions do not establish that the trial itself used that design or that analysis. The registry’s own sample-size justification and statistical plan are not reported in the registry record.
Planning estimates depend on assumptions about the effect to detect and the variability of the outcome. In general, if those assumptions differ from the values seen in a completed study, the planning exercise may not describe the precision achieved. Any participant-per-arm figure in a planning illustration is a target under its assumptions, not an observed result and not observed power. The primary estimates, their uncertainty and the trial’s full analysis plan are not reported in the registry record.
Finally, the registry lists numerous secondary outcomes, including imaging measurements, visual acuity and pharmacokinetic measures. In general, testing multiple outcomes or time points can increase the chance of finding an apparently notable result by chance if no multiplicity strategy is used. Whether and how multiplicity was controlled is not reported in the registry record. No method, test statistic, model specification or adjustment can be attributed to this study beyond the details explicitly recorded.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary endpoint assessed at baseline, 6 months, 12 months and 18 months, as well as a broad set of secondary outcomes. These include additional imaging measures of GA, visual-acuity outcomes and pharmacokinetic measures. Assessing multiple outcomes and time points raises a multiplicity question: in general, the more statistical comparisons made, the greater the possibility of chance findings unless the analysis plan accounts for that multiplicity.
The registry information does not state whether the primary outcome was tested at each follow-up time, whether one visit was designated as the principal comparison, or whether any adjustment or hierarchical testing strategy was used. A multiplicity procedure and its rationale are not reported in the registry record. No conclusion about control of false-positive findings can therefore be drawn from the endpoint list alone.
For missing data, the registry says only participants available at the specified time points were analyzed. It also defines an efficacy population that requires data for at least 75% of visits from post-baseline treatment month 2 through treatment month 19, identified as at least 14 visits. Participants who developed CNV in the study eye during treatment are excluded from that population. These features affect which observations contribute to the primary analysis.
The registry does not report visit-specific analysis counts, reasons for unavailable measurements, the extent of missing data, or the method used to handle missingness. It also does not report whether sensitivity analyses assessed the effect of different missing-data assumptions. Consequently, the relationship between the stated efficacy population and all randomized participants, and the robustness of the primary estimate to missing observations, cannot be assessed 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 |
|---|---|---|---|
| Placebo | 9 | 46 | 19.6% |
| GSK933776 (3 mg/kg) | 11 | 46 | 23.9% |
| GSK933776 (6 mg/kg) | 9 | 48 | 18.8% |
| GSK933776 (15 mg/kg) | 12 | 51 | 23.5% |
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 |
|---|---|
| Placebo | 31 of 46 |
| GSK933776 (3 mg/kg) | 37 of 46 |
| GSK933776 (6 mg/kg) | 32 of 48 |
| GSK933776 (15 mg/kg) | 37 of 51 |
Most frequent serious adverse event terms
| Event term | Organ system | Placebo | GSK933776 (3 mg/kg) | GSK933776 (6 mg/kg) | GSK933776 (15 mg/kg) |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | 0 of 46 | 0 of 46 | 1 of 48 | 2 of 51 |
| Urinary tract infection | Infections and infestations | 0 of 46 | 2 of 46 | 0 of 48 | 0 of 51 |
| Cardiac failure congestive | Cardiac disorders | 0 of 46 | 2 of 46 | 0 of 48 | 0 of 51 |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | 1 of 46 | 0 of 46 | 1 of 48 | 0 of 51 |
| vertigo | Ear and labyrinth disorders | 0 of 46 | 0 of 46 | 0 of 48 | 2 of 51 |
| Cholecystitis infective | Infections and infestations | 0 of 46 | 0 of 46 | 0 of 48 | 1 of 51 |
| Liver abscess | Infections and infestations | 0 of 46 | 0 of 46 | 1 of 48 | 0 of 51 |
| Lung infection | Infections and infestations | 0 of 46 | 1 of 46 | 0 of 48 | 0 of 51 |
| Pharyngitis | Infections and infestations | 1 of 46 | 0 of 46 | 0 of 48 | 0 of 51 |
| Pyelonephritis | Infections and infestations | 0 of 46 | 1 of 46 | 0 of 48 | 0 of 51 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Placebo | GSK933776 (3 mg/kg) | GSK933776 (6 mg/kg) | GSK933776 (15 mg/kg) |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | 3 of 46 | 6 of 46 | 4 of 48 | 1 of 51 |
| Retinal haemorrhage | Eye disorders | 3 of 46 | 4 of 46 | 3 of 48 | 4 of 51 |
| Bronchitis | Infections and infestations | 5 of 46 | 2 of 46 | 2 of 48 | 3 of 51 |
| Blepharitis | Eye disorders | 2 of 46 | 5 of 46 | 4 of 48 | 1 of 51 |
| Headache | Nervous system disorders | 1 of 46 | 4 of 46 | 4 of 48 | 3 of 51 |
| Sinusitis | Infections and infestations | 6 of 46 | 1 of 46 | 1 of 48 | 3 of 51 |
| Nausea | Gastrointestinal disorders | 2 of 46 | 4 of 46 | 1 of 48 | 4 of 51 |
| Hypertension | Vascular disorders | 2 of 46 | 2 of 46 | 4 of 48 | 3 of 51 |
| Nasopharyngitis | Infections and infestations | 3 of 46 | 3 of 46 | 1 of 48 | 3 of 51 |
| Dizziness | Nervous system disorders | 2 of 46 | 3 of 46 | 3 of 48 | 2 of 51 |
Serious events with the highest arm-level rate: urinary tract infection (4.3%), cardiac failure congestive (4.3%), pneumonia (3.9%), vertigo (3.9%), lung infection (2.2%).
The registry reports serious adverse-event counts and other adverse-event counts for the placebo and GSK933776 dose groups. For placebo, 9 of 46 participants at risk had a serious adverse event and 31 of 46 had an other adverse event. For GSK933776 at 3 mg/kg, the corresponding counts were 11 of 46 and 37 of 46. For GSK933776 at 6 mg/kg, they were 9 of 48 and 32 of 48. For GSK933776 at 15 mg/kg, they were 12 of 51 and 37 of 51.
These are descriptive participant counts. The registry information does not provide uncertainty intervals or adjusted comparisons for these counts, so they should not be interpreted as a formal test of differences between groups. The serious adverse-event terms listed include urinary tract infection at 4.3%, cardiac failure congestive at 4.3%, pneumonia at 3.9%, vertigo at 3.9%, lung infection at 2.2% and pharyngitis at 2.2%. The information reported does not identify a group-specific distribution or the denominator for these term percentages.
Deaths are not reported in the registry record. Serious and other adverse-event summaries should be read as safety reporting, not as proof of a causal relationship to study treatment.
12. What the Result Does, and Does Not, Mean
The registry record establishes that this was a randomized, placebo-controlled phase 2 study of intravenous GSK933776 at three listed doses in adults with GA secondary to AMD. It identifies change in study-eye GA area assessed by color fundus photographs as the primary endpoint and gives the follow-up schedule and a 90% confidence interval as the dispersion measure.
Those design and endpoint details explain what the study set out to evaluate, but they do not reveal the observed efficacy result. The primary estimates, confidence-interval limits and between-group comparisons are not reported in the registry record. It is therefore not possible to describe the direction, magnitude or precision of the primary outcome from the available registry information. The study’s purpose and completed status do not fill that gap.
The endpoint measures structural area, not visual acuity. Visual-acuity measures are listed among the secondary outcomes, but their results are not reported in the registry record. Nor are the listed secondary imaging and pharmacokinetic results reported in the information available for this analysis. No conclusion about those outcomes should be inferred from the primary endpoint description or the safety counts.
The safety record lists participants with serious and other adverse events by group. These counts describe reported events but do not, without comparative estimates and their uncertainty, establish whether groups differed. The listed serious-event terms have percentages, but the reporting details do not identify their denominators or group-specific distributions. Deaths are not reported in the registry record.
In general, the interpretation of a clinical trial result depends on the estimated effect, its uncertainty, the analysis population, missing-data handling and the prespecified statistical plan. Several of these details, including the primary results and the methods for multiplicity and missing data, are not reported in the registry record. The defensible conclusion is limited to what the record describes: the study design, outcome definitions, population criteria and adverse-event counts. It does not support a claim that GSK933776 did or did not affect GA progression.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of how a randomized design can be paired with an imaging-based endpoint in a progressive retinal condition. The primary measure is change in GA area in the study eye, assessed from color fundus photographs, with assessments specified over follow-up. That choice makes the estimand structural: it concerns measured area change, not directly a change in visual function.
The record also illustrates that the phrase “primary endpoint” does not by itself provide enough information to interpret a result. The registry identifies the measure, time points, population criteria and confidence-interval type, but the primary estimates and between-group comparisons are not reported in the registry record. Without those values, readers cannot evaluate effect magnitude or precision.
The efficacy-population definition matters statistically. Requiring repeated visit data and excluding participants who developed CNV in the study eye may make the analyzed population differ from the full randomized population. The registry also states that only participants available at a given time point were analyzed. These choices affect which participants and observations contribute to the endpoint and underscore the importance of transparent analysis-population and missing-data reporting.
The listed secondary outcomes create a further interpretive issue. Multiple outcomes and time points can complicate inference, so it is important to know whether a multiplicity strategy was prespecified and how it was applied. That information is not reported in the registry record. The safety counts likewise demonstrate why descriptive event frequencies should be distinguished from formal comparative estimates.
For researchers, the record highlights the value of reporting outcome estimates with uncertainty, analysis counts, missing-data methods and the statistical plan alongside the design. Those elements are needed to move from knowing what a trial set out to measure to understanding what its data show.
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.
A central limitation is that the registry information does not report the primary efficacy estimates, confidence-interval limits or between-group comparisons. It also does not report results for the listed secondary outcomes. As a result, the observed treatment differences and their precision cannot be assessed from the registry record.
The primary endpoint unit is recorded as square millimeter (m^2). This stated unit is retained as written in the registry; the record does not clarify the notation. The endpoint description also distinguishes color fundus photographs for the primary outcome from fundus autofluorescence images referenced in the efficacy-population criteria and secondary outcomes. That distinction makes it important to keep the measurement methods separate when interpreting the registry wording.
The efficacy population requires repeated visit data, with at least 75% of visits from post-baseline treatment month 2 through treatment month 19, identified as at least 14 visits. It excludes participants who developed CNV in the study eye during treatment. The record does not report how many participants met these criteria, how many contributed data at each visit, or how these exclusions affected the comparison.
Only participants available at a specified time point are described as analyzed at that time point. The reasons for unavailable measurements and the method for addressing missing data are not reported in the registry record. The analysis model, handling of repeated measurements, image-reading procedures, multiplicity strategy and full statistical analysis plan are also not reported. Finally, serious-event term percentages lack a stated denominator and group-specific breakdown in the information reported, and deaths are not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Clinical Study to Investigate Safety and Efficacy of GSK933776 in Adult Patients With Geographic Atrophy Secondary to Age-related Macular Degeneration — NCT01342926.
- Registry record last updated 2017-05-05; status last verified 2017-03.
- Results first posted 2017-05-05.
- 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
NCT01342926 is a completed phase 2 randomized, quadruple-masked, parallel-group, placebo-controlled study sponsored by GlaxoSmithKline. It enrolled 191 adults with geographic atrophy secondary to age-related macular degeneration. The listed interventions were intravenous GSK933776 at 3 mg/kg, 6 mg/kg or 15 mg/kg, and intravenous placebo.
The primary endpoint was change from baseline in study-eye GA area assessed by color fundus photographs, with assessments at baseline, 6 months, 12 months and 18 months and a 90% confidence interval specified. The efficacy population had repeated-visit criteria and excluded participants who developed CNV in the study eye during treatment.
The registry lists serious and other adverse-event counts by group, along with several serious-event terms. Primary efficacy estimates, between-group results, detailed missing-data methods, multiplicity procedures and the full statistical analysis plan are not reported in the registry record.