This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Depot Formulation of Sunitinib Malate (GB-102) Compared to Aflibercept in Subjects With Wet AMD (NCT03953079), a randomized phase 2 study. The primary outcome is Time to First Rescue Treatment.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03953079 |
| Phase | Phase 2 |
| Condition | Neovascular Age-Related Macular Degeneration |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 56 |
| Arms in the primary outcome | 3 |
| Lead sponsor | Graybug Vision |
| Results posted | Yes |
2. Clinical Question
Population
The study enrolled subjects with neovascular, or wet, age-related macular degeneration. The registry lists 56 participants overall. The primary endpoint description does not specify a separate analysis population, and eligibility details beyond the listed condition are not reported in the registry record.
Intervention
The experimental treatment was intravitreal GB-102, a depot formulation of sunitinib malate. Two GB-102 regimens appear in the arm descriptions: 1 mg at Baseline and Month 6, or 2 mg at Baseline followed by 1 mg at Month 6. Both regimens included sham visits at Months 2, 4, 8 and 10.
Comparator
The active comparator was intravitreal aflibercept 2 mg, scheduled at Baseline and Months 2, 4, 6, 8 and 10. The study was randomized and parallel-arm. The registry describes visual examiner masking, but other masking arrangements are not reported in the registry record.
Primary question
The primary endpoint was time from Baseline to first rescue treatment, assessed through 12 months. In practical terms, the endpoint asks how long participants went before receiving rescue treatment under the study’s rescue criteria. The registry reports Kaplan-Meier median estimates for the two GB-102 arms with 80% confidence intervals; a median estimate is not reported in the registry record for the aflibercept arm.
3. Trial Design
This was a Phase 2b, multicenter, randomized, active-controlled, parallel-arm study. Its registry title describes a dose-ranging comparison of depot sunitinib malate, GB-102, with aflibercept in subjects with wet age-related macular degeneration. Enrollment was 56. The listed treatment arms were GB-102 1 mg/1 mg, GB-102 2 mg/1 mg, and aflibercept 2 mg. The registry describes the masking as single and specifies that visual examiners were masked; it does not report further details about who else was masked or how masking was maintained.
Participants assigned to GB-102 1 mg/1 mg were scheduled to receive GB-102 1 mg in the study eye at Baseline and Month 6, with sham at Months 2, 4, 8 and 10. The GB-102 2 mg/1 mg regimen used GB-102 2 mg at Baseline and GB-102 1 mg at Month 6, with sham at the same intervening visits. Participants assigned to aflibercept were scheduled to receive 2 mg at Baseline and Months 2, 4, 6, 8 and 10. These schedules describe planned study treatments; rescue treatments were separately tracked.
The study began on 2019-09-26, had a primary completion date of 2020-12-15, and is listed as completed. The registry describes the purpose as evaluating the safety and duration of repeated intravitreal injections of three GB-102 dose levels compared with aflibercept, while the arm descriptions and posted outcome data list two GB-102 regimens. The reason for this difference is not reported in the registry record. Further details about the protocol, including eligibility criteria, allocation procedures, and treatment adherence, 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.
Core Study
| Stage | GB-102 1 mg/1 mg | GB-102 2 mg/1 mg | Aflibercept 2 mg |
|---|---|---|---|
| STARTED | 21 | 22 | 13 |
| COMPLETED | 20 | 18 | 12 |
| NOT COMPLETED | 1 | 4 | 1 |
Reasons for not completing this period:
| Reason | GB-102 1 mg/1 mg | GB-102 2 mg/1 mg | Aflibercept 2 mg |
|---|---|---|---|
| Withdrawal by Subject | 1 | 2 | 1 |
| COVID-19 | 0 | 1 | 0 |
| Difficulties leaving the house | 0 | 1 | 0 |
Extension Study
| Stage | GB-102 1 mg/1 mg | GB-102 2 mg/1 mg | Aflibercept 2 mg |
|---|---|---|---|
| STARTED | 12 | 10 | 6 |
| COMPLETED | 6 | 4 | 1 |
| NOT COMPLETED | 6 | 6 | 5 |
Reasons for not completing this period:
| Reason | GB-102 1 mg/1 mg | GB-102 2 mg/1 mg | Aflibercept 2 mg |
|---|---|---|---|
| Withdrawal by Subject | 1 | 0 | 0 |
| Received Rescue Treatment | 5 | 6 | 5 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: Safety Set includes all subjects all randomized subjects who receive at least one dose of study treatment.
| Characteristic | Unit | GB-102 1 mg/1 mg | GB-102 2 mg/1 mg | Aflibercept 2 mg | Total |
|---|---|---|---|---|---|
| Participants analysed | 21 | 22 | 13 | 56 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 | 1 | 1 | 2 |
| Age, Categorical: >=65 years | Participants | 21 | 21 | 12 | 54 |
| Age, Continuous | years | 80 (SD 8.08) | 77.8 (SD 8.58) | 77.5 (SD 9.13) | 78.5 (SD 8.44) |
| Sex: Female, Male: Female | Participants | 15 | 13 | 8 | 36 |
| Sex: Female, Male: Male | Participants | 6 | 9 | 5 | 20 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 | 0 | 0 | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 20 | 22 | 13 | 55 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 1 | 0 | 1 | 2 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 20 | 22 | 12 | 54 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 21 | 22 | 13 | 56 |
| Best Corrected Visual Acuity (ETDRS Letters) | ETDRS letters | 70.8 (SD 11.50) | 70.7 (SD 9.92) | 69.6 (SD 14.67) | 70.5 (SD 11.52) |
| Central Subfield Thickness | microns | 211.0 (SD 47.14) | 232.5 (SD 54.37) | 217.5 (SD 31.66) | 221.0 (SD 47.42) |
6. Primary Endpoint
The registry lists the primary outcome as Time to First Rescue Treatment, measured over Baseline through 12 months.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | 80% Confidence Interval |
| Unit | months |
| Endpoint classification | Time-to-Event Analysis |
The primary endpoint measures the time from Baseline until a participant first receives rescue treatment, with follow-up described as Baseline through 12 months. The registry specifies a Kaplan-Meier estimate of the median time. A median time is the point at which the estimated proportion remaining without the event reaches one half; in this setting, the event is first rescue treatment. It describes the timing of the first event rather than the total number of rescue treatments.
Time-to-event methods are used because participants may experience the event at different times, while some may not experience it during the observation period. Kaplan-Meier estimation accounts for that structure by using the information available up to each participant’s event or last observed time. This general explanation does not establish which censoring rules or analysis population were used in this study; those details are not reported in the registry record.
The endpoint is relevant to a study comparing treatment schedules because it records when rescue treatment was first needed under the trial’s criteria. It does not, by itself, describe visual acuity, retinal anatomy, the total number of treatments, or the reasons a participant met rescue criteria. The registry reports median times of 5.0 months for GB-102 1 mg/1 mg and 4.0 months for GB-102 2 mg/1 mg, each with an 80% confidence interval. A median and confidence interval for aflibercept are not reported in the registry record. Without that arm’s estimable value and without a reported sponsor comparison, the posted primary endpoint does not provide a complete quantified comparison across all three arms.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports a median time to first rescue treatment of 5.0 months in the GB-102 1 mg/1 mg arm, with an 80% confidence interval from 3.0 to 8.0 months. In the GB-102 2 mg/1 mg arm, the median was 4.0 months, with an 80% confidence interval from 3.0 to 4.0 months. These are arm-level Kaplan-Meier estimates. The intervals express uncertainty around the respective median estimates; they are not ranges containing a fixed proportion of individual participants’ rescue times.
The aflibercept arm has no posted median or confidence interval for this endpoint. The registry record therefore does not permit a three-arm comparison of the primary endpoint using the posted medians. The absence of an aflibercept estimate should not be interpreted as a median of zero, an absence of rescue treatment, or evidence that no participants received rescue treatment. The reason a value is unavailable or not estimable is not reported in the registry record.
The displayed confidence intervals are 80% intervals, not 95% intervals. As a general statistical concept, a confidence interval describes uncertainty in an estimate under the method used to construct it. A narrower interval indicates greater precision under that method, but interval width alone does not establish a treatment difference. These two GB-102 intervals overlap, and there is no reported sponsor analysis of a difference between the GB-102 arms. No hazard ratio or other inferential comparison for the primary endpoint is reported in the registry record. The record also does not report an analysis comparing either GB-102 regimen with aflibercept.
Interpretation should account for the small arm sizes: the posted primary endpoint has 21.0 participants in the GB-102 1 mg/1 mg arm and 22.0 in the GB-102 2 mg/1 mg arm, while 13.0 participants are listed for aflibercept. A limited amount of information can make time-to-event estimates imprecise or leave a median unavailable, depending on event occurrence and follow-up. The registry record does not provide enough detail to identify why the aflibercept median is absent, or to determine how many participants were censored or how censoring was handled.
Accordingly, the posted primary results describe the estimated timing of first rescue treatment in the two GB-102 arms, with the uncertainty represented by the stated 80% confidence intervals. They do not establish a comparative effect across all treatments. The randomized design supplies a framework for comparison, but the registry results available for this endpoint do not include the full arm-level estimates or a reported inferential comparison needed to quantify that question.
9. Statistical Methods Explained
The primary endpoint is a time-to-event outcome: time from Baseline to first rescue treatment. The registry says the medians were estimated using Kaplan-Meier methods and reports 80% confidence intervals for the two GB-102 arms. No sponsor-reported hazard ratios or other primary-endpoint analyses appear in the registry record. This matters because a set of arm-specific medians is descriptive, while a treatment comparison needs an appropriate comparative estimate and its uncertainty.
What does a Kaplan-Meier median represent?
As a general explanation, Kaplan-Meier estimation uses information from participants who have experienced the event and from participants who are observed only up to a last known time without the event. The latter observations are commonly described as censored. The method estimates the probability of remaining event-free over time; its median is the time at which that estimated probability reaches one half. A median may be unavailable if the estimate does not reach that point during the observed data. The registry does not report whether this explains the missing aflibercept median.
The method’s interpretation depends on the event definition, follow-up, censoring, and population analyzed. The primary endpoint description identifies first rescue treatment as the event and gives a Baseline through 12 months timeframe. Specific rescue criteria, censoring rules, numbers censored, and the analysis population are not reported in the registry record. Those omissions limit assessment of how the estimates were constructed and how much information contributed at later times.
How should the confidence intervals be read?
The 80% confidence intervals quantify uncertainty in the estimated medians under the method used. In general, a confidence interval is not an interval containing a stated proportion of individual participants’ outcomes. Nor does overlap or non-overlap of separate arm-specific intervals, by itself, replace a direct test or estimate of the between-arm difference. The registry record does not report a direct comparison for this endpoint. The intervals are 80%, so they should not be described as 95% intervals.
The posted primary values are 5.0 months with an interval from 3.0 to 8.0 months for GB-102 1 mg/1 mg, and 4.0 months with an interval from 3.0 to 4.0 months for GB-102 2 mg/1 mg. No additional calculation is needed to interpret them: each is an arm-specific estimated median, accompanied by its reported interval. A corresponding aflibercept estimate is not reported in the registry record, so an unadjusted difference between arms should not be constructed from the available primary values.
Why is an unadjusted recalculation different?
For some secondary outcomes, the posted summary values support simple, unadjusted recalculations of differences between arms. Such recalculations are not the same as a sponsor’s prespecified analysis. They may not account for the trial design, repeated measurements, covariates, missing data, or other analytic choices. The registry lists no reported analyses for the secondary outcomes, so the recalculated comparisons are best treated as exploratory descriptions of the posted summaries, not as confirmatory trial conclusions.
Where a secondary comparison has an unadjusted p-value, it reflects that particular comparison without adjustment for the number of outcomes or comparisons examined. A p-value does not measure the size or clinical importance of an effect, and a value above a conventional threshold does not establish equivalence or absence of an effect. Confidence intervals convey a range of values compatible with the data under the stated calculation; their width is especially relevant when group sizes are small. The secondary outcome record includes multiple outcome types, including counts, continuous measurements, and rescue-related measures, so they do not all share the same statistical interpretation.
What do the sample-size illustrations mean?
The sample-size illustrations are planning calculations based on observed effects, not the trial’s own design justification and not observed power. The stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and detection of a specified fraction of the observed effect. For continuous and binary outcomes, the illustrations express participants per arm. The time-to-event description refers instead to a total number of events, but no time-to-event planning values are available in the posted comparison data.
These illustrations are hypothetical and depend on the observed effect, which can be unstable in a small study. Smaller assumed effects lead to larger planning requirements in the listed illustrations, but they do not show that the trial had a particular probability of detecting an effect. The registry’s sample-size justification and the assumptions used for the actual trial design are not reported in the registry record. The illustrations should not be read as a retrospective measure of trial success or as evidence that an observed result is reliable.
Finally, the registry’s lack of reported analyses is distinct from evidence that no analyses were performed. It means the posted record does not include sponsor-reported inferential results for these outcomes. A full interpretation would depend on the protocol and statistical analysis plan, including prespecification, analysis populations, handling of missing observations, and multiplicity procedures; those details are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists multiple secondary outcomes, including rescue-related measures, visual acuity outcomes, central subfield thickness, and exudation. It does not report a multiplicity adjustment or identify a family of outcomes for which error rates were controlled. Without such information, unadjusted secondary p-values should be interpreted as exploratory. A nominal result from one of many comparisons can arise by chance, and results across outcomes should not be treated as independent confirmations of the same conclusion.
Missing-data methods and analysis populations are not reported in the registry record. The primary endpoint description names a Kaplan-Meier estimate but does not state the population included, censoring rules, or how incomplete follow-up was handled. The record does not specify whether the analyses used all randomized participants, participants who received treatment, or another population. It also does not report how missing continuous or categorical outcome observations were addressed. These omissions matter because the amount and pattern of missing information can influence estimates and their precision.
The record also does not provide the statistical analysis plan, interim analysis details, or a sample-size justification. None should be inferred from the reported results or from planning illustrations based on observed effects. The illustrations describe hypothetical group sizes under stated assumptions; they are not the trial’s design rationale or observed power.
Because these details are absent, the posted summaries support a descriptive reading but not a full audit of prespecification and analysis decisions. This is particularly relevant for the secondary outcomes, for which no sponsor-reported analyses are listed, and for the primary endpoint, where no aflibercept median or direct comparison is posted. The missing methodological information does not establish that the analyses were inappropriate; it limits what can 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 |
|---|---|---|---|
| GB-102 1 mg/1 mg | 2 | 21 | 9.5% |
| GB-102 2 mg/1 mg | 4 | 22 | 18.2% |
| Aflibercept 2 mg | 1 | 13 | 7.7% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| GB-102 1 mg/1 mg | 0 of 21 |
| GB-102 2 mg/1 mg | 0 of 22 |
| Aflibercept 2 mg | 0 of 13 |
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 |
|---|---|
| GB-102 1 mg/1 mg | 20 of 21 |
| GB-102 2 mg/1 mg | 22 of 22 |
| Aflibercept 2 mg | 8 of 13 |
Most frequent serious adverse event terms
| Event term | Organ system | GB-102 1 mg/1 mg | GB-102 2 mg/1 mg | Aflibercept 2 mg |
|---|---|---|---|---|
| Retinal detachment | Eye disorders | 0 of 21 | 1 of 22 | 0 of 13 |
| Pneumonia | Infections and infestations | 1 of 21 | 0 of 22 | 0 of 13 |
| Acute myeloid leukemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0 of 21 | 1 of 22 | 0 of 13 |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0 of 21 | 1 of 22 | 0 of 13 |
| Atrial fibrillation | Cardiac disorders | 0 of 21 | 1 of 22 | 0 of 13 |
| Sepsis | Infections and infestations | 1 of 21 | 0 of 22 | 0 of 13 |
| Urosepsis | Infections and infestations | 0 of 21 | 1 of 22 | 0 of 13 |
| Metastatic gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0 of 21 | 1 of 22 | 0 of 13 |
| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 0 of 21 | 0 of 22 | 1 of 13 |
Most frequent non-serious adverse event terms
| Event term | Organ system | GB-102 1 mg/1 mg | GB-102 2 mg/1 mg | Aflibercept 2 mg |
|---|---|---|---|---|
| Vitreous floaters | Eye disorders | 6 of 21 | 10 of 22 | 2 of 13 |
| Iritis | Eye disorders | 5 of 21 | 10 of 22 | 0 of 13 |
| Product residue present | Investigations | 4 of 21 | 6 of 22 | 0 of 13 |
| Retinal haemorrhage | Eye disorders | 4 of 21 | 4 of 22 | 1 of 13 |
| Visual acuity reduced | Eye disorders | 3 of 21 | 4 of 22 | 0 of 13 |
| Eye pain | Eye disorders | 1 of 21 | 5 of 22 | 1 of 13 |
| Nasopharyngitis | Infections and infestations | 3 of 21 | 1 of 22 | 2 of 13 |
| Subretinal fluid | Eye disorders | 2 of 21 | 2 of 22 | 1 of 13 |
| Cataract | Eye disorders | 2 of 21 | 3 of 22 | 0 of 13 |
| Visual impairment | Eye disorders | 1 of 21 | 2 of 22 | 0 of 13 |
Serious events with the highest arm-level rate: intraductal proliferative breast lesion (7.7%), pneumonia (4.8%), sepsis (4.8%), retinal detachment (4.5%), acute myeloid leukemia (4.5%).
The registry lists serious adverse events in all three arms. Serious adverse events affected 2 participants in the GB-102 1 mg/1 mg arm, 4 in the GB-102 2 mg/1 mg arm, and 1 in the aflibercept 2 mg arm. The numbers at risk for these summaries were 21, 22, and 13, respectively. No deaths are listed in any arm. These are descriptive counts; the record does not provide a comparative statistical analysis of serious adverse events.
Other adverse events affected 20 participants in the GB-102 1 mg/1 mg arm, 22 in the GB-102 2 mg/1 mg arm, and 8 in the aflibercept arm. The registry also lists several serious-event terms with percentages, including intraductal proliferative breast lesion at 7.7%, pneumonia and sepsis at 4.8% each, and retinal detachment, acute myeloid leukemia, and bladder cancer at 4.5% each. The record does not clearly establish from these listings how the terms map to individual arms, and the percentages should not be assigned to an arm without that information.
Adverse-event counts in a small study are descriptive and do not, by themselves, establish whether a treatment caused an event or whether event rates differ between treatments. The registry record does not report a detailed safety analysis, event timing, severity beyond the serious classification, or treatment-relatedness for these listings. The safety figures therefore describe what was posted, not a causal comparison.
12. What the Result Does, and Does Not, Mean
The primary results describe estimated time to first rescue treatment in the two GB-102 arms over a Baseline through 12 months timeframe. The reported medians are 5.0 months for GB-102 1 mg/1 mg and 4.0 months for GB-102 2 mg/1 mg, with 80% confidence intervals reported for each. These estimates are not a measure of all treatments received, nor do they directly measure visual acuity or retinal anatomy.
The aflibercept median is not reported in the registry record, and there is no reported sponsor comparison for the primary endpoint. Consequently, these posted results do not quantify the relative primary-endpoint outcome between GB-102 and aflibercept, or establish a difference between the GB-102 regimens. A missing estimate is not evidence of a favorable or unfavorable result. The reason the aflibercept estimate is unavailable is not reported in the registry record.
The secondary summaries add descriptions of rescue criteria, treatment counts, visual acuity, and other eye-related outcomes. Their interpretation is limited by the absence of sponsor-reported analyses and by the lack of reported multiplicity, missing-data, and analysis-population details. Any unadjusted recalculated comparisons are exploratory and should not be given the same weight as a prespecified, fully reported analysis.
More generally, statistical estimates summarize the observed trial data under particular methods. They do not independently establish clinical importance, causation, or whether a result will apply to people outside the study. A randomized design is intended to support comparisons, but interpretation also depends on sample size, follow-up, endpoint definitions, protocol conduct, and the analysis plan. Several of those details are not reported in the registry record.
The appropriate conclusion from the posted results is therefore bounded: the registry reports two GB-102 estimates for time to first rescue treatment, with their stated uncertainty, alongside descriptive secondary and safety summaries. It does not provide a complete primary comparison with aflibercept or enough information to make broader claims about comparative effects.
13. Why This Trial Matters Statistically
This trial illustrates why a clinical question and the posted numerical result need to be read together. The primary endpoint is a time-to-event measure, and its useful interpretation depends on more than a single median: arm-level estimates, uncertainty, the event definition, follow-up, and the handling of participants without an observed event all matter. Here, medians and 80% confidence intervals are reported for the two GB-102 arms, while a median for aflibercept is not reported in the registry record. That missing arm estimate limits the primary comparison.
The record also distinguishes descriptive outcomes from inferential conclusions. A randomized, parallel-arm design creates a structure for comparison, but arm-level summaries alone do not demonstrate a treatment difference. Where secondary contrasts are recalculated from posted summaries, they remain unadjusted and exploratory. The range of secondary outcomes also raises the general issue of multiplicity: findings across numerous outcomes need to be interpreted in light of whether and how the analysis plan accounted for multiple testing.
Small arm sizes and incomplete methodological reporting further show why precision and transparency matter. Confidence intervals communicate uncertainty around estimates, while the absence of details on analysis populations, missing data, censoring, and prespecified testing makes it difficult to assess all sources of uncertainty. The sample-size illustrations are planning scenarios based on observed effects; they are not observed power and do not establish that the trial was designed with those assumptions.
For biostatistical interpretation, the main lesson is to separate what the registry reports from what would require additional analysis or protocol information. The reported estimates are informative descriptions of this study’s posted results, but a comparative claim needs an estimable result for each relevant arm and an appropriate analysis. Missing detail should remain a limitation rather than being filled by assumption.
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 most direct limitation for interpreting the primary endpoint is that the registry reports a median and 80% confidence interval for each GB-102 arm but no median estimate for aflibercept. No sponsor-reported hazard ratio or other primary comparison is listed. The reason for the missing aflibercept estimate is not reported in the registry record, so it cannot be assumed to reflect a particular event pattern or analysis decision.
The overall enrollment was 56, with 21.0 participants listed for GB-102 1 mg/1 mg, 22.0 for GB-102 2 mg/1 mg, and 13.0 for aflibercept in the primary outcome. These arm sizes limit the amount of information available for estimation, especially for a time-to-event outcome. The registry does not give event counts, follow-up completeness, censoring details, or the analysis population, which prevents a fuller evaluation of the precision and representativeness of the primary estimates.
Several limitations concern reporting rather than necessarily trial conduct. The registry record does not report a statistical analysis plan, sample-size justification, multiplicity procedure, interim analyses, missing-data methods, or definitions of the analysis populations. It also lists no sponsor-reported analyses for the secondary outcomes. As a result, recalculated unadjusted comparisons cannot be checked against a prespecified analysis, and their exploratory status should be kept clear.
The secondary outcomes span multiple measurement types and time points. The registry does not report enough detail to determine how repeated observations were modeled or how missing values at visits were handled. One listed secondary arm label is “Dose,” while the intervention information identifies aflibercept; the registry record does not explain this labeling. This makes that arm’s attribution in the secondary outcome record less clear. Finally, adverse-event summaries are descriptive and do not provide a reported comparative safety analysis or enough detail to establish causality.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Depot Formulation of Sunitinib Malate (GB-102) Compared to Aflibercept in Subjects With Wet AMD — NCT03953079.
- Registry record last updated 2022-01-19; status last verified 2022-01.
- Results first posted 2022-01-11.
- 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.
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
NCT03953079 is a completed, randomized, Phase 2b, multicenter, active-controlled, parallel-arm study of GB-102 versus aflibercept in neovascular age-related macular degeneration. The registry lists 56 participants and describes visual examiner masking. The primary endpoint was Kaplan-Meier median time to first rescue treatment through 12 months.
The posted primary medians are 5.0 months for GB-102 1 mg/1 mg and 4.0 months for GB-102 2 mg/1 mg, each with an 80% confidence interval. An aflibercept median and a sponsor-reported comparative analysis are not reported in the registry record. Secondary outcomes and adverse-event summaries are also posted, but the record does not include sponsor-reported secondary analyses or key details on multiplicity, missing data, and analysis populations.