Comparison · NCT03507686-16c3bc1c
Treatment Period 1: BIIB111 vs Treatment Period 2: BIIB111: Number of Participants With Anti-drug Antibodies Post-treatment at Month 12
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. Treatment Period 1: BIIB111 vs Treatment Period 2: BIIB111: Number of Participants With Anti-drug Antibodies Post-treatment at Month 12. Trial comparisons, record NCT03507686-16c3bc1c. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03507686-16c3bc1c
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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 | 0 | 0.0602 | wilson | |
| Risk in group 2 | 0 | 0.00000000000000000694 | 0.0642 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.0642 | 0.0602 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
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 | Treatment Period 1: BIIB111 | After vitrectomy and retinal detachment in the study eye 1, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 1. | 0 | 60 | OG000 |
| Group 2 | Treatment Period 2: BIIB111 | After vitrectomy and retinal detachment in the study eye 2, participants received a single administration of BIIB111, 1 \* 10\^11 gp, as a sub-retinal injection on Day 0 (surgery day) of Period 2. | 0 | 56 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Anti-drug Antibodies Post-treatment at Month 12
- Description
- Participants with antibodies to the REP-1 transgenic product are reported.
- Time frame
- Month 12
- Population
The immunogenicity analysis set included all participants who completed the 'Day of Surgery' visit of Period 1 or 2 with baseline sample and at least one post-surgery sample evaluable for immunogenicity.
Source ClinicalTrials.gov
Trial
- Title
- A Safety Study of Retinal Gene Therapy for Choroideremia With Administration of BIIB111
- NCT number
- NCT03507686
- Phases
- PHASE2
- Conditions
- Choroideremia
- Interventions
- BIIB111
- Lead sponsor
- Biogen
- Results first posted
- 2023-09-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03507686?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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