Comparison · NCT04278417-7acefebc
Brolucizumab 6 mg vs Panretinal Photocoagulation Laser Arm: Number and Percentage of Subjects With no Proliferative Diabetic Retinopathy (PDR) at Week 96 for the Study Eye
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Brolucizumab 6 mg vs Panretinal Photocoagulation Laser Arm: Number and Percentage of Subjects With no Proliferative Diabetic Retinopathy (PDR) at Week 96 for the Study Eye. Trial comparisons, record NCT04278417-7acefebc. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04278417-7acefebc
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.606 | 0.551 | 0.659 | wilson | |
| Risk in group 2 | 0.284 | 0.236 | 0.337 | wilson | |
| Risk difference, group 1 minus group 2 | 0.323 | 0.246 | 0.394 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.14 | 1.75 | 2.61 | log | |
| Odds ratio, group 1 over group 2 | 3.89 | 2.77 | 5.45 | log | |
| Number needed to treat, for one more participant with the outcome on Brolucizumab 6 mg than on Panretinal Photocoagulation Laser Arm | 3.1 | 2.54 | 4.07 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Brolucizumab 6 mg | Brolucizumab 6 mg: 3 x q6w loading then q12w maintenance through Week 90, with the option from Week 48 onwards to extend the treatment interval by 6 weeks at a time up to 24 weeks and revert to q12w if disease worsens. More frequent injection with q6w interval in the maintenance phase could be administered at the discretion of the Investigator if the disease worsens. | 188 | 310 | OG000 |
| Group 2 | Panretinal Photocoagulation Laser Arm | Initial treatment in 1-4 sessions up to Week 12, followed by additional PRP treatment as needed. | 86 | 303 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number and Percentage of Subjects With no Proliferative Diabetic Retinopathy (PDR) at Week 96 for the Study Eye
- Description
Proliferative diabetic retinopathy (PDR) is derived from the diabetic retinopathy severity scale (DRSS) as assessed by the central reading center (CRC) using 7-field color fundus photography image. The DRSS on the original score with scores varying from 10 (DR absent) to 85 (very advanced PDR) were then converted into a 12-level scale (Range is from 1 - diabetic retinopathy (DR) absent, to 12- very advanced PDR). (A lower score represents a better outcome.) The event of No PDR is then defined as DRSS (12-level scale) \< 7.
- Time frame
- Week 96
- Population
- Full Analysis Set- Last Observation Carried Forward (FAS - LOCF), for patients with a valid measurement with no protocol deviations with impact.
Source ClinicalTrials.gov
Trial
- Title
- Study of Efficacy and Safety of Brolucizumab Versus Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy
- NCT number
- NCT04278417
- Phases
- PHASE3
- Conditions
- Proliferative Diabetic Retinopathy
- Interventions
- Brolucizumab 6 mg, Panretinal photocoagulation laser
- Lead sponsor
- Novartis Pharmaceuticals
- Results first posted
- 2024-08-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04278417?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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