Comparison · NCT02087085-sae
400 µg Brimonidine Implant vs Sham: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. 400 µg Brimonidine Implant vs Sham: serious adverse events. Trial comparisons, record NCT02087085-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02087085-sae
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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 | 0.312 | 0.244 | 0.389 | wilson | |
| Risk in group 2 | 0.237 | 0.177 | 0.31 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0745 | -0.0248 | 0.172 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.31 | 0.911 | 1.9 | log | |
| Odds ratio, group 1 over group 2 | 1.46 | 0.881 | 2.41 | log | |
| Number needed to harm, for one more participant with a serious adverse event on 400 µg Brimonidine Implant than on Sham | 13.4 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: sham.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | 400 µg Brimonidine Implant | 400 µg brimonidine implant in the study eye, administered by intravitreal injections using the Brimonidine Drug Delivery System (Brimo DDS®) applicator every 3 months from Baseline (Day 1) through Month 21. | 48 | 154 | EG000 |
| Group 2 | Sham | Sham treatment (control) in the study eye, administered by intravitreal injections using a needleless DDS applicator every 3 months from Baseline (Day 1) through Month 21. | 37 | 156 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From first dose of study drug to date of last visit (up to approximately 33 months)
Source ClinicalTrials.gov
Trial
- Title
- A Safety and Efficacy Study of Brimonidine Intravitreal Implant in Geographic Atrophy Secondary to Age-related Macular Degeneration
- NCT number
- NCT02087085
- Phases
- PHASE2
- Conditions
- Geographic Atrophy, Macular Degeneration
- Interventions
- 400 µg Brimonidine Implant, Sham
- Lead sponsor
- Allergan
- Results first posted
- 2019-04-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02087085?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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