Comparison · NCT03439345-d9f21c2c
Fenofibrate 145 mg vs Placebo Oral Tablet: Number of Participants With Progression to Referable Diabetic Retinopathy or Maculopathy, or Treatment
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. Fenofibrate 145 mg vs Placebo Oral Tablet: Number of Participants With Progression to Referable Diabetic Retinopathy or Maculopathy, or Treatment. Trial comparisons, record NCT03439345-d9f21c2c. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03439345-d9f21c2c
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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 | 0.227 | 0.195 | 0.263 | wilson | |
| Risk in group 2 | 0.292 | 0.256 | 0.331 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0647 | -0.115 | -0.0141 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.778 | 0.639 | 0.948 | log | |
| Odds ratio, group 1 over group 2 | 0.713 | 0.547 | 0.93 | log | |
| Number needed to treat, for one fewer participant with the outcome on Fenofibrate 145 mg than on Placebo Oral Tablet | 15.4 | 8.7 | 71.1 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Fenofibrate 145 mg | Fenofibrate 145 mg: One tablet (taken daily with normal renal function, taken every second day with chronic kidney disease) | 131 | 576 | OG000 |
| Group 2 | Placebo Oral Tablet | Placebo Oral Tablet: One tablet (taken daily with normal renal function, taken every second day with chronic kidney disease) | 168 | 575 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Progression to Referable Diabetic Retinopathy or Maculopathy, or Treatment
- Description
Primary outcome was a composite of the development of referable diabetic retinopathy or referable maculopathy, or treatment for diabetic retinopathy or maculopathy (including retinal laser therapy, vitrectomy or intravitreal injection of medication). Referable diabetic retinopathy was defined by the NHS Scotland's grading criteria as any development of R3, R4 or M2 disease. R3 (referable background diabetic retinopathy): any of four or more blot hemorrhages in both inferior and superior hemi-fields, or venous beading, or intraretinal microvascular abnormalities (IRMA); R4 (proliferative diabetic retinopathy): any active new vessels, or vitreous hemorrhage; M2 (referable maculopathy): any blot hemorrhages, or hard exudates within a radius of ≤1 optic disc diameter of the centre of the fovea. Adverse event reports of eye procedures, vitreous haemorrhages and macular oedema were adjudicated by experienced doctors at the Central Co-ordinating Office (CCO), masked to treatment allocation.
- Time frame
- 4.0 years (interquartile range, 3.6 to 4.3) years
- Population
- Intention-to-treat comparisons among all randomised participants of the effects of allocation to fenofibrate versus placebo during the scheduled treatment period on time to the first occurrence.
Source ClinicalTrials.gov
Trial
- Title
- Lowering Events in Non-proliferative Retinopathy in Scotland
- NCT number
- NCT03439345
- Phases
- PHASE4
- Conditions
- Diabetic Retinopathy
- Interventions
- Fenofibrate 145 mg, Placebo Oral Tablet
- Lead sponsor
- University of Oxford
- Results first posted
- 2025-05-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03439345?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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