Comparison · NCT01006538-8e2dddf9
Arm A: Epimacular Bracytherapy + Lucentis® vs Arm B: Lucentis® Only: Percentage of Subjects Gaining ≥ 0 ETDRS Letters
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. Arm A: Epimacular Bracytherapy + Lucentis® vs Arm B: Lucentis® Only: Percentage of Subjects Gaining ≥ 0 ETDRS Letters. Trial comparisons, record NCT01006538-8e2dddf9. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01006538-8e2dddf9
On this page
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 | 0.373 | 0.315 | 0.435 | wilson | |
| Risk in group 2 | 0.462 | 0.375 | 0.552 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0892 | -0.196 | 0.0177 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.807 | 0.627 | 1.04 | log | |
| Odds ratio, group 1 over group 2 | 0.692 | 0.444 | 1.08 | log | |
| Number needed to treat, for one fewer participant with the outcome on Arm A: Epimacular Bracytherapy + Lucentis® than on Arm B: Lucentis® Only | 11.2 | from the risk difference interval | the interval includes no difference |
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 | Arm A: Epimacular Bracytherapy + Lucentis® | Arm A: A single surgical procedure with epimacular brachytherapy using the VIDION® System, with Lucentis® (0.5 mg) administered on a monthly basis as required.~Epimacular Brachytherapy: Strontium-90. The device delivers 24 Gray of beta radiation to the CNV lesion. Each device is calibrated for a set duration. | 91 | 244 | OG000 |
| Group 2 | Arm B: Lucentis® Only | Arm B: Lucentis® (0.5 mg) administered on a monthly basis as required, using the re-treatment criteria below.~Ranibizumab: intravitreal injection (0.5 mg) administered on a monthly basis as required, using the re-treatment criteria | 55 | 119 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Percentage of Subjects Gaining ≥ 0 ETDRS Letters
- Description
Manifest refraction and BCVA measurements were performed according to the standard procedure originally developed for Early Treatment for Diabetic Retinopathy Study (ETDRS) and adapted for the Age Related Eye Disease Study (AREDS) protocol. Visual acuity testing was measured at a distance of 4 meters and, for subjects with sufficiently reduced vision, at 1 meter. The ETDRS charts consist of 14 lines, each comprising a series of 5 letters of equal difficulty, with standardized spacing between letters and rows (total 70 letters). Minimum is 0 (no letters read at 1 m) and maximum possible is 100 (70 letters read at 4 m + 30). If visual acuity is so poor that the subject cannot read any of the largest letters at 1 meter count fingers (CF), hand movements (HM) and light perception (PL) are tested.~Participants with an improvement in BCVA by more than 0 EDTRS letters at month 12 compared with baseline were considered for this outcome measure.
- Time frame
- 12 months
- Population
Source ClinicalTrials.gov
Trial
- Title
- Macular EpiRetinal Brachytherapy Versus Lucentis® Only Treatment (MERLOT)
- NCT number
- NCT01006538
- Phases
- PHASE4
- Conditions
- Macular Degeneration
- Interventions
- Epimacular Brachytherapy, Ranibizumab
- Lead sponsor
- King's College Hospital NHS Trust
- Results first posted
- 2019-07-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01006538?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT01006538-8e2dddf9