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 Safety and Efficacy Trial of a Treat and Extend Protocol Using Ranibizumab With and Without Laser Photocoagulation for Diabetic Macular Edema (NCT01934556), a randomized phase 1, phase 2 study. The primary outcome is Mean Change in Vision at 24 Months.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01934556 |
| Phase | Phase 1, Phase 2 |
| Condition | Diabetic Macular Edema |
| Allocation | Randomized |
| Design model | Factorial |
| Masking | None (open label) |
| Enrollment | 150 |
| Arms in the primary outcome | 3 |
| Lead sponsor | Palmetto Retina Center, LLC |
| Results posted | Yes |
2. Clinical Question
Population
People with diabetic macular edema. The registry describes study eyes and an enrollment of 150, but does not report further eligibility details in the record.
Intervention
Ranibizumab 0.3 mg given using a treat-and-extend regimen, either alone or with guided laser photocoagulation. The protocol descriptions for these arms are incomplete in the registry record.
Comparator
Monthly intravitreal ranibizumab 0.3 mg. The registry describes injections every 4 weeks for 24 months in the Monthly arm.
Primary question
How did visual acuity at 24 months compare across the monthly, TREX, and GILA arms, as assessed by change in ETDRS score from Day 0?
The registry frames the study as an assessment of the safety, tolerability, and efficacy of monthly ranibizumab compared with a treat-and-extend approach. Its title also identifies a comparison involving laser photocoagulation. The three named groups are Monthly, TREX, and GILA. The trial is described as randomized, but the registry’s posted outcome results do not give a formal statistical comparison among the three groups.
The primary outcome concerns visual acuity in the study eye. The description says a higher ETDRS letter score represents better visual function. However, the registry labels the outcome “Mean Change in Vision at 24 Months” while specifying the median as the statistical parameter. That difference in wording matters: the posted values should not be assumed to be means when the registry identifies the parameter as a median.
The available result entries give a value for each arm but no reported between-arm estimate, confidence interval for a contrast, or p-value. They therefore describe the groups individually, rather than establishing whether the regimens differ statistically. The clinical question is identifiable from the trial design, but the posted results do not answer it through a reported comparative analysis.
3. Trial Design
This was a randomized, open-label Phase I/II study with a factorial model designation. The registry identifies 150 as the enrollment and lists diabetic macular edema as the condition. The study is marked completed; the recorded start is 2013-11 and primary completion is 2017-04. The registry does not report the method used to generate or conceal the random allocation sequence.
The Monthly arm is described as receiving intravitreal ranibizumab 0.3 mg every 4 weeks for 24 months, with 30 eyes listed in its description. The TREX arm is described as starting with monthly injections for four visits. At the fourth visit, Week 12, eyes meeting the stated central foveal thickness condition would enter an extension phase. The remainder of the TREX schedule is cut off in the registry record, so its subsequent visit rules cannot be fully described.
The GILA description combines monthly ranibizumab for four visits with guided laser photocoagulation. It describes laser treatment at visit 2, Week 4, and then every 3 months when leakage is present on fluorescein angiography. The rest of this arm description is also incomplete. The record does not provide enough detail to reconstruct all treatment rules or to determine precisely how the factorial designation was implemented.
Masking is listed as none. This means the record does not describe a blinded trial; it does not, by itself, establish how outcome assessors or analysts were handled. The primary outcome is visual-acuity change at 24 months, described as measured during weeks 92–107 from Day 0. Secondary outcomes include adverse events, injections and office visits, retinal thickness, vision changes, progression to proliferative diabetic retinopathy, and ability to begin the extension phase. The record lists eight secondary outcomes but no reported analysis entries.
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 | Monthly | TREX | GILA |
|---|---|---|---|
| STARTED | 30 | 60 | 60 |
| COMPLETED | 25 | 44 | 50 |
| NOT COMPLETED | 5 | 16 | 10 |
Reasons for not completing this period:
| Reason | Monthly | TREX | GILA |
|---|---|---|---|
| Withdrawal by Subject | 0 | 1 | 1 |
| Lost to Follow-up | 4 | 10 | 7 |
| Death | 1 | 5 | 2 |
Analysis population for the primary outcome, as defined in the registry: For those lost to follow-up, last observation carried forward
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 | Monthly | TREX | GILA | Total |
|---|---|---|---|---|---|
| Participants analysed | 30 | 60 | 60 | 150 | |
| Age, Continuous | Years | 58.7 (52.5 to 66.0) | 59.4 (54.2 to 65.2) | 59.9 (53.3 to 66.7) | 59.5 (53.5 to 66.0) |
| Sex: Female, Male: Female | Participants | 16 | 32 | 24 | 72 |
| Sex: Female, Male: Male | Participants | 14 | 28 | 36 | 78 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 1 | 0 | 1 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 12 | 21 | 18 | 51 |
| Race (NIH/OMB): White | Participants | 12 | 31 | 31 | 74 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 6 | 7 | 11 | 24 |
| Region of Enrollment: United States | participants | 30 | 60 | 60 | 150 |
| Body-Mass Index | Units of measure "kg/m^2" | 32.2 (29.0 to 33.7) | 31.9 (28.3 to 35.4) | 30.9 (27.5 to 35.3) | 31.6 (28.1 to 35.0) |
| Mean Duration of Diabetes | Years | 15 (9.25 to 20) | 13.5 (9 to 19.25) | 13.5 (9 to 19.25) | 14 (9 to 19.25) |
| Phakic Status | participants | 23 | 48 | 46 | 117 |
| Mean Best Corrected Visual Acuity (ETDRS Letters) | units on a scale | 67.5 (55.3 to 72.8) | 65.5 (55.0 to 80.0) | 67.0 (59.8 to 73.0) | 66.5 (57.0 to 75.8) |
| Central Retinal Thickness (microns) | Microns | 415 | 452 | 484 | 452 |
6. Primary Endpoint
The registry lists the primary outcome as Mean Change in Vision at 24 Months, measured over 2 Years.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | units on a scale |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is titled “Mean Change in Vision at 24 Months.” Its description defines the measure as change in ETDRS visual acuity at 24 months, during weeks 92–107, from Day 0. ETDRS testing is described in the record as a widely accepted international standard for assessing visual function. The record also states that a higher letter score represents better functioning.
Change from baseline is useful because it expresses the follow-up score in relation to the participant’s starting score, rather than treating the follow-up score alone as the outcome. In general, this can help describe how visual acuity changes during follow-up. It does not on its own show whether a difference between treatment groups is attributable to treatment; that requires an appropriate comparative analysis and its uncertainty.
There is an important reporting inconsistency. Although the endpoint title and description use “mean change,” the registry identifies the statistical parameter as the median and the dispersion as the inter-quartile range. The arm results report central values of 72.5 for Monthly, 75.0 for TREX, and 75.0 for GILA. The accompanying lower and upper values are 67.25 and 81.5, 69.0 and 80.0, and 69.8 and 82.3, respectively. The record does not clarify whether these bounds are the stated inter-quartile ranges or another summary. The results therefore need to be read with this unresolved ambiguity, not as a clearly specified mean-based endpoint.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary outcome gives a central value for each of the three arms: 72.5 for Monthly, 75.0 for TREX, and 75.0 for GILA. Each value is accompanied by lower and upper values, but the record does not clearly explain their interpretation. Although the outcome metadata name the inter-quartile range as the dispersion measure, the result entries do not resolve the inconsistency between the “mean change” title and the median parameter. These summaries should therefore be treated as the registry’s reported arm-level results, not as a definitive account of the endpoint’s calculation.
The outcome description says that visual acuity was assessed as change from Day 0 at 24 months, within weeks 92–107, and that higher ETDRS letter scores represent better function. That provides the direction of the underlying scale. It does not establish that the arm-level values are changes in the direction or units a reader might infer from their magnitudes, given the unresolved endpoint labeling. The registry does not provide baseline values alongside these results or explain the displayed bounds.
Most importantly, the posted results do not report a contrast between arms. There is no registry analysis entry for a two-arm comparison, and no reported treatment-effect estimate, confidence interval for a group difference, or p-value. The individual summaries cannot substitute for a comparison: assessing whether groups differ requires an estimate of the contrast and its uncertainty. The trial’s randomized design is relevant to such an analysis, but randomization alone does not supply a reported result that is absent from the record.
The group counts in the primary result entries are 30 for Monthly and 60 each for TREX and GILA. The arm descriptions refer to eyes, while the record’s overall enrollment is expressed without clarifying the analysis unit for each endpoint. That makes it important not to assume that all counts represent independent participants rather than eyes or another analysis unit.
Consequently, the posted summaries are descriptive. They do not establish that one regimen is better, worse, equivalent, or non-inferior to another. Nor do they establish whether the differences that may be apparent between central values are meaningful or compatible with chance variation. The record does not provide a formal inferential analysis for the primary outcome, and the missing analysis details leave the precision of any comparative conclusion unknown.
9. Statistical Methods Explained
Statistical interpretation depends on what was measured, how each value was summarized, and whether a comparison was actually performed. For this trial, those questions are especially important because the registry uses inconsistent wording for the primary endpoint and posts arm-level summaries without a reported comparative analysis.
What does the primary summary represent?
The endpoint title and description refer to mean change in visual acuity, but the statistical parameter is listed as median. A mean is an arithmetic average and can be influenced by unusually high or low values. A median is the middle value after observations are ordered and is less affected by extremes. They are different summaries and need not give the same result. The record does not say whether the title or the specified parameter reflects the analysis that generated the posted values.
The dispersion is identified as the inter-quartile range. In general, this describes the span of the middle half of observations and gives information about variability around a median. However, the posted arm entries use lower and upper values without explaining them, and the spread field is missing. It is therefore not possible to confirm from the registry record how those bounds relate to the stated dispersion. They should not be treated as confidence limits or as a specified range without clarification.
Why is a between-arm estimate needed?
An arm summary describes one group. A comparative analysis instead estimates a contrast between groups, such as a difference in endpoint values, and quantifies uncertainty in that contrast. A confidence interval, in general, gives a range of values compatible with the data and the assumptions of the analysis. It helps show precision; it is not a guarantee that the true effect lies within the interval. The registry record does not post a confidence interval or other uncertainty estimate for a primary-outcome comparison.
A p-value, in general, describes how unusual data at least as inconsistent with a specified null hypothesis would be if that hypothesis and the analysis assumptions were true. It does not measure the size or importance of an effect. No p-value for the primary comparison is reported. Without a defined contrast and uncertainty measure, the arm summaries alone do not support a formal claim of a difference or no difference.
What does the design tell us?
Random allocation can help make treatment groups comparable on average, including with respect to factors that were not measured, when the allocation is properly implemented and analyzed. It does not guarantee balance in every realized trial, and it does not resolve missing outcome data or problems in endpoint definition. The record labels the study randomized but does not report the sequence-generation or allocation-concealment methods.
The record also labels the model factorial, while listing three arms and describing a laser component in GILA. A factorial analysis usually evaluates more than one intervention factor and may assess both separate effects and their interaction. That is a general description, not a claim about the analysis performed in this trial. The registry does not report the factorial contrasts, interaction analysis, or a statistical plan that would establish how the designation was used. Its kind description says the results are not reduced to one comparison, and no analysis entries are posted.
How should the planning illustration be understood?
The record describes planning calculations based on the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is specified as a fraction of the observed effect. These are planning assumptions, not evidence that the trial had a particular probability of detecting an effect. A sample-size illustration estimates how many participants per arm might be needed under stated assumptions; it is not “observed power,” and it does not replace an analysis of the trial’s actual results.
General sample-size calculations depend on the chosen effect size, variability, significance threshold, allocation, and analysis method. If the observed effect used as the planning reference is imprecise, planning values based on it can also be unstable. The registry record does not report the original sample-size justification, the trial’s own design calculation, or enough comparative outcome information to reproduce a trial-specific estimate. No recalculated comparison is reported in the record.
Why can over-dispersion matter?
For outcomes that are counts, a simple statistical model may assume that variability follows a particular relationship to the average. Over-dispersion occurs when observed variability is greater than that assumption allows. In general, ignoring it can make uncertainty appear smaller than it is. This trial lists count-type secondary outcomes, such as injections and office visits, but the record does not report the analysis models, distributions, or diagnostic checks used for them. It is therefore not possible to say whether over-dispersion was assessed or how it affected any estimates.
These methods points distinguish what is generally needed for interpretation from what the registry actually reports. Here, endpoint summaries are available, but the endpoint definition is internally inconsistent and comparative analyses are not posted. Those limits prevent a complete assessment of effect size, precision, and model adequacy.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary visual-acuity outcome and eight secondary outcomes, covering safety, treatment burden, retinal thickness, visual changes, disease progression, and ability to enter the extension phase. Testing many outcomes can raise the chance of at least one apparently notable result when each is assessed separately. Statistical methods for addressing this issue can include prespecifying a hierarchy, adjusting thresholds, or distinguishing confirmatory from exploratory outcomes. The registry record does not report whether any such approach was planned or used.
The result record lists no analysis entries. It therefore does not provide a multiplicity plan, outcome-specific estimates, p-values, confidence intervals, or a clear account of which analyses were considered primary for inference. The primary endpoint wording is itself inconsistent: its title says mean change, while the statistical parameter is median. The record does not explain whether this reflects a change in analysis or a labeling error.
For people lost to follow-up, the primary outcome description says last observation carried forward was used. In general, this method substitutes a participant’s last recorded observation for a later missing value. It relies on an assumption about what the unobserved outcome would have been; that assumption may not fit every participant’s course. The record does not describe the amount or timing of missingness, the reasons for loss to follow-up, or sensitivity analyses using alternative assumptions.
The record does not report a full analysis population definition, such as whether all randomized participants were included, how protocol deviations were handled, or how the eye-level outcome was handled when participants contributed more than one eye. These details matter for interpreting both the estimand and the uncertainty of a result. Beyond the stated last-observation-carried-forward approach for loss to follow-up, the analysis rules are not reported in 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 |
|---|---|---|---|
| Monthly | 11 | 30 | 36.7% |
| TREX | 30 | 60 | 50.0% |
| GILA | 46 | 60 | 76.7% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Monthly | 1 of 30 |
| TREX | 5 of 60 |
| GILA | 2 of 60 |
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 |
|---|---|
| Monthly | 30 of 30 |
| TREX | 60 of 60 |
| GILA | 60 of 60 |
Most frequent serious adverse event terms
| Event term | Organ system | Monthly | TREX | GILA |
|---|---|---|---|---|
| Hypertension | Vascular disorders | 1 of 30 | 2 of 60 | 6 of 60 |
| Skin/Soft Tissue Infection | Infections and infestations | 1 of 30 | 3 of 60 | 4 of 60 |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | 0 of 30 | 4 of 60 | 3 of 60 |
| Myocardial Infarction | Cardiac disorders | 0 of 30 | 4 of 60 | 2 of 60 |
| Congestive Heart Failure | Cardiac disorders | 0 of 30 | 2 of 60 | 4 of 60 |
| Hypo/Hyperglycemia | Endocrine disorders | 0 of 30 | 2 of 60 | 2 of 60 |
| Fractured Bone | Injury, poisoning and procedural complications | 0 of 30 | 1 of 60 | 2 of 60 |
| Cerebrovascular Accident | Nervous system disorders | 0 of 30 | 0 of 60 | 3 of 60 |
| Renal Failure | Renal and urinary disorders | 0 of 30 | 1 of 60 | 2 of 60 |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | 1 of 30 | 1 of 60 | 1 of 60 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Monthly | TREX | GILA |
|---|---|---|---|---|
| Hypertension | Vascular disorders | 10 of 30 | 21 of 60 | 26 of 60 |
| Respiratory Infection | Infections and infestations | 12 of 30 | 22 of 60 | 14 of 60 |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | 12 of 30 | 16 of 60 | 18 of 60 |
| Skin Infection | Infections and infestations | 6 of 30 | 18 of 60 | 20 of 60 |
| Hypo/Hyperglycemia | Endocrine disorders | 7 of 30 | 12 of 60 | 14 of 60 |
| Eye Discomfort/Discharge | Eye disorders | 6 of 30 | 9 of 60 | 15 of 60 |
| Vitreous Floaters | Eye disorders | 7 of 30 | 6 of 60 | 7 of 60 |
| Allergy | Immune system disorders | 5 of 30 | 9 of 60 | 5 of 60 |
| Sinusitis | Infections and infestations | 5 of 30 | 9 of 60 | 3 of 60 |
| Peripheral Edema | Vascular disorders | 1 of 30 | 6 of 60 | 8 of 60 |
Serious events with the highest arm-level rate: hypertension (10.0%), myocardial infarction (6.7%), congestive heart failure (6.7%), skin/soft tissue infection (6.7%), pneumonia (6.7%).
The registry reports serious-adverse-event counts of 11 in Monthly, 30 in TREX, and 46 in GILA, with corresponding at-risk counts of 30, 60, and 60. It separately reports other-adverse-event counts of 30, 60, and 60, with the same respective at-risk counts. These are group-level counts as entered in the registry. The record does not clarify whether each count represents people with at least one event, events themselves, or another counting rule, so they should not be converted into rates or interpreted as the number of separate events without that information.
Deaths are reported as 1 in Monthly, 5 in TREX, and 2 in GILA. The registry does not state in these results whether deaths were judged related to treatment, nor does a count alone establish causation. The listed serious-event terms include Hypertension at 10.0%, Myocardial Infarction at 6.7%, Congestive Heart Failure at 6.7%, Skin/Soft Tissue Infection at 6.7%, Pneumonia at 6.7%, and Cerebrovascular Accident at 5.0%. The record does not specify the denominator or whether people could contribute to more than one term.
These figures are descriptive safety reports, not comparative estimates adjusted for follow-up or exposure. The record does not provide timing, severity grading beyond the serious-event category, event duration, exposure-adjusted analyses, or a formal between-arm safety comparison. Differences in the reported counts should not be interpreted as evidence of a treatment effect on safety.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a randomized, open-label Phase I/II study compared three named approaches for diabetic macular edema and posted arm-level values for a visual-acuity outcome. It also provides descriptive adverse-event counts and identifies several secondary outcomes. These registry entries help readers understand the trial’s intended comparison and the information entered into the registry.
The record does not establish a statistically supported difference in visual acuity between Monthly, TREX, and GILA. Although the posted central values are 72.5, 75.0, and 75.0, respectively, there is no reported contrast, confidence interval, or p-value. Without those, the summaries do not quantify the comparative effect or its precision. They also do not establish equivalence or show that any difference is clinically important.
The interpretation of the primary values is further limited by the discrepancy between the endpoint’s “Mean Change” title and its median parameter, as well as by the unexplained lower and upper values. The outcome is described as change from Day 0 at 24 months, but the record does not provide the details needed to reconcile those labels. The result entries should therefore not be restated as a clearly defined mean treatment effect.
The safety counts similarly do not show whether an intervention caused an event or whether one group had greater risk. The record does not provide a comparative safety analysis or clarify all counting and denominator details. Counts may also be difficult to compare without information about exposure and follow-up.
In general, a registry result is most informative when the endpoint, analysis population, missing-data rules, treatment contrast, and uncertainty estimates are clearly reported. Several of these elements are absent or ambiguous. The posted results can be read as descriptive registry summaries, but they do not support a conclusion that one regimen works better, is safer, or is no different from another. No medical advice follows from these registry entries.
13. Why This Trial Matters Statistically
This trial raises several practical statistical issues that recur in clinical research. First, the primary endpoint’s title and analysis parameter do not agree: the title refers to a mean, while the record specifies a median. A clear distinction matters because these summaries answer different descriptive questions and can lead to different interpretations. The posted result should be accompanied by an unambiguous definition of the statistic and its dispersion.
Second, arm-level summaries do not answer a randomized trial’s comparative question by themselves. A treatment comparison needs a defined contrast, an analysis population, and an estimate of uncertainty. Without those, readers cannot determine whether a difference is precise, compatible with chance variation, or clinically meaningful. This is particularly important when the record lists three arms but no formal comparisons.
Third, incomplete protocol descriptions complicate understanding of what was compared. The Monthly regimen is described, but the TREX and GILA text is truncated. The factorial model designation also does not explain which factors or interactions were analyzed. Clear intervention descriptions and a prespecified analysis plan help readers link treatment assignment to the reported estimand.
Finally, missing-data handling and multiplicity deserve attention. Last observation carried forward is named for lost-to-follow-up primary outcomes, but the extent of missingness and sensitivity analyses are not reported. The record lists multiple secondary outcomes without describing a strategy for interpreting results across them. These omissions illustrate why transparent reporting requires more than posting endpoint values: it also requires definitions, analysis methods, and uncertainty measures that let readers assess the strength and scope of the evidence.
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.
Several limitations specific to this trial record constrain interpretation. The registry’s primary outcome description calls the measure mean change, while the parameter is identified as median. The result entries also include lower and upper values without clarifying how they correspond to the stated inter-quartile range. This leaves uncertainty about the exact summary statistic and dispersion being presented.
The trial has three named arms, yet no formal two-arm comparison is posted. The record does not report a comparative effect estimate, confidence interval, or p-value for the primary outcome. It also does not explain how the factorial model designation relates to the arms, or which contrasts and potential interactions were planned. Accordingly, the posted endpoint summaries do not support a comparative conclusion.
Descriptions of TREX and GILA are incomplete in the registry record, so the treatment schedules cannot be fully reconstructed. The record identifies the study as open-label and unmasked but does not provide the methods for random sequence generation or allocation concealment. It also does not explain the analysis unit for the outcomes, despite describing eyes in the arms and reporting overall enrollment.
For missing primary outcomes, last observation carried forward is stated, but missingness counts, reasons, and sensitivity analyses are not reported. The record does not provide a full analysis-population definition, a multiplicity strategy, or statistical methods for the secondary outcomes. Safety results lack details about event-counting rules, exposure, follow-up, and causal attribution. These are limitations of the information in the registry record and should not be mistaken for proof that the study did not collect or analyze such information elsewhere.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Safety and Efficacy Trial of a Treat and Extend Protocol Using Ranibizumab With and Without Laser Photocoagulation for Diabetic Macular Edema — NCT01934556.
- Registry record last updated 2020-11-17; status last verified 2020-10.
- Results first posted 2020-11-17.
- 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
The record describes a completed, randomized, open-label Phase I/II study of ranibizumab for diabetic macular edema. It lists a Monthly arm, a TREX arm, and a GILA arm combining ranibizumab with guided laser photocoagulation. The primary outcome concerns ETDRS visual-acuity change at 24 months, but the title’s reference to a mean conflicts with the listed median parameter.
Arm-level primary values and safety counts are posted, but no formal analysis entries or between-arm estimates are reported. The record does not provide confidence intervals or p-values for the primary comparison, and parts of the TREX and GILA descriptions are incomplete. It states that last observation carried forward was used for primary outcomes among those lost to follow-up but gives no missingness details or sensitivity analyses.
The posted information is therefore descriptive and does not establish comparative efficacy or safety. The endpoint definition, statistical analysis, and interpretation of several result fields remain unclear in the registry record.