Trial · NCT03439345
Lowering Events in Non-proliferative Retinopathy in Scotland
NCT03439345, Phase 4, Completed, University of Oxford; results first posted 2025-05-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Lowering Events in Non-proliferative Retinopathy in Scotland. Trials, record NCT03439345. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03439345
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lowering Events in Non-proliferative Retinopathy in Scotland
- NCT number
- NCT03439345
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,151 participants, actual
- Lead sponsor
- University of Oxford
- Conditions
- Diabetic Retinopathy
- Interventions
- Fenofibrate 145 mg, Placebo Oral Tablet
- First posted
- 2018-02-20
- Last updated
- 2025-05-14
- Other registries' IDs
- isrctn:ISRCTN15073006
- Results first posted
- 2025-05-14
Source ClinicalTrials.gov
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Progression to Referable Diabetic Retinopathy or Maculopathy, or Treatment | 4.0 years (interquartile range, 3.6 to 4.3) years | 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. |
| Secondary | Number of Participants With the Individual Component of the Composite Primary Outcome: Development of Referable Diabetic Retinopathy or Maculopathy | 4.0 years (interquartile range, 3.6 to 4.3) years | Progression of Diabetic Retinopathy/Maculopathy to a referable grade (R3 or R4 or M2) based on the NHS Scotland grading scheme in at least one eye. |
| Secondary | Number of Participants With the Individual Component of Composite Primary Outcome: Treatment for Diabetic Retinopathy or Maculopathy | 4.0 years (interquartile range, 3.6 to 4.3) years | Treatment for diabetic retinopathy or maculopathy (including intravitreal injection of medication, retinal laser therapy, or vitrectomy) in either eye. |
| Secondary | Number of Participants With Any Progression of Diabetic Retinopathy or Maculopathy Across the NHS Scotland Retinopathy Grading Scale | 4.0 years (interquartile range, 3.6 to 4.3) years | Any progression of diabetic retinopathy or maculopathy across the NHS Scotland retinopathy grading scale. R4 = Proliferative DR, R3 = Referable background DR, R2 = Observable background DR. R1 = Mild background DR, R0 = No DR anywhere (where R4 is the highest severity grade and R0 is the lowest grade); M2 = Referable maculopathy, M1 = Observable maculopathy, M0 = No Maculopathy (where M2 is the highest severity grade and M0 is the lowest grade). |
| Secondary | Number of Participants With Referable Maculopathy (Exudates or Blot Haemorrhages Within One Disc Diameter of the Fovea) | 4.0 years (interquartile range, 3.6 to 4.3) years | The presence of hard exudates or blot haemorrhages within 1 disc diameter of the macula/fovea |
| Secondary | Number of Participants With The Development of Macular Oedema | 4.0 years (interquartile range, 3.6 to 4.3) years | The accumulation of macular fluid as determined by optical coherence tomography (OCT) imaging or on adverse event report |
| Secondary | Visual Acuity | 4.0 years (interquartile range, 3.6 to 4.3) years | Based on measurement of visual acuity at retinal screening visits. Baseline visual acuity was taken from routine measurement within NHS Scotland's Diabetic Eye Screening programme (using the latest value within 18 months of randomisation). Visual acuity after randomisation was obtained by averaging available results for a participant. Conversion from Snellen to LogMAR was applied where necessary. This analysis is based on the better eye: if only 1 eye with results, analyse that eye; if 2 eyes, use eye with better acuity; if identical acuity in both eyes, use the right eye. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). Lower scores indicate better vision. |
| Secondary | Visual Function, Based on the National Eye Institute Visual Functioning Questionnaire 25 (VFQ-25). | 4.0 years (interquartile range, 3.6 to 4.3) years | Visual function is based on the Visual Function Questionnaire-25. Visual function was defined by the composite score derived from the VFQ-25. VFQ-25 data were collected at the screening visit, after two years and at the end of the study. Results from two years and end-of-study were averaged to provide a trial-averaged result for a participant. The VFQ-25 composite score ranges from 0 to 100, where higher scores indicate better visual function. It is calculated by averaging results from up to 11 vision-related sub-scales. |
| Secondary | Quality of Life, Based on the EQ-5D Index Score | 4.0 years (interquartile range, 3.6 to 4.3) years | Quality of life was measured using the EQ-5D instrument, and valued by mapping to the EQ-5D-3L UK value set using the mapping function developed by Hernandez Alava et al. Pharmaco Economics (2022). EQ-5D data were collected at the screening visit, after two years and at the end of the study. Results from two years and end-of-study were averaged to provide a trial-averaged result for a participant. Possible scores range from -0.59 to 1.00, where 1 is the best possible health state and 0 represents a quality of life considered equivalent to death. |
| Secondary | Quality of Life, Based on the EQ-5D Visual Analogue Scale. | 4.0 years (interquartile range, 3.6 to 4.3) years | EQ-5D Visual Analogue Scale data were collected at the screening visit, after two years and at the end of the study. Results from two years and end-of-study were averaged to provide a trial-averaged result for a participant. EQ VAS scores range from 0 to 100, where 100 is the best possible health state. |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 registered outcomesOutcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Progression to Referable Diabetic Retinopathy or Maculopathy, or Treatment | 4.0 years (interquartile range, 3.6 to 4.3) years | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With the Individual Component of the Composite Primary Outcome: Development of Referable Diabetic Retinopathy or Maculopathy | 4.0 years (interquartile range, 3.6 to 4.3) years | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With the Individual Component of Composite Primary Outcome: Treatment for Diabetic Retinopathy or Maculopathy | 4.0 years (interquartile range, 3.6 to 4.3) years | 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 first occurrence. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Any Progression of Diabetic Retinopathy or Maculopathy Across the NHS Scotland Retinopathy Grading Scale | 4.0 years (interquartile range, 3.6 to 4.3) years | 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 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Referable Maculopathy (Exudates or Blot Haemorrhages Within One Disc Diameter of the Fovea) | 4.0 years (interquartile range, 3.6 to 4.3) years | 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 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With The Development of Macular Oedema | 4.0 years (interquartile range, 3.6 to 4.3) years | 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 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Visual Acuity | 4.0 years (interquartile range, 3.6 to 4.3) years | Intention-to-treat comparisons among all randomised participants of the effects of allocation to fenofibrate versus placebo during the scheduled treatment period on trial-averaged visual acuity. | LogMAR | MEAN |
| SECONDARY | Visual Function, Based on the National Eye Institute Visual Functioning Questionnaire 25 (VFQ-25). | 4.0 years (interquartile range, 3.6 to 4.3) years | Intention-to-treat comparisons among all randomised participants of the effects of allocation to fenofibrate versus placebo during the scheduled treatment period on trial-averaged VFQ-25 Composite Score. Collected at baseline, at approximately 2 years and at the end of the trial. | score on a scale | MEAN |
| SECONDARY | Quality of Life, Based on the EQ-5D Index Score | 4.0 years (interquartile range, 3.6 to 4.3) years | Intention-to-treat comparisons among all randomised participants of the effects of allocation to fenofibrate versus placebo during the scheduled treatment period on trial-averaged EQ-5D Index Score. Collected at baseline, at approximately 2 years and at the end of the trial. | score on a scale | MEAN |
| SECONDARY | Quality of Life, Based on the EQ-5D Visual Analogue Scale. | 4.0 years (interquartile range, 3.6 to 4.3) years | Intention-to-treat comparisons among all randomised participants of the effects of allocation to fenofibrate versus placebo during the scheduled treatment period on trial-averaged EQ-5D Visual Analogue Scale. Collected at baseline, at approximately 2 years and at the end of the trial. | score on a scale | MEAN |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 outcomesResults by group56
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Progression to Referable Diabetic Retinopathy or Maculopathy, or Treatment | Fenofibrate 145 mg | 131 | Participants | ||
| Number of Participants With Progression to Referable Diabetic Retinopathy or Maculopathy, or Treatment | Placebo Oral Tablet | 168 | Participants | ||
| Number of Participants With the Individual Component of the Composite Primary Outcome: Development of Referable Diabetic Retinopathy or Maculopathy | Fenofibrate 145 mg | 130 | Participants | ||
| Number of Participants With the Individual Component of the Composite Primary Outcome: Development of Referable Diabetic Retinopathy or Maculopathy | Placebo Oral Tablet | 168 | Participants | ||
| Number of Participants With the Individual Component of Composite Primary Outcome: Treatment for Diabetic Retinopathy or Maculopathy | Fenofibrate 145 mg | 17 | Participants | ||
| Number of Participants With the Individual Component of Composite Primary Outcome: Treatment for Diabetic Retinopathy or Maculopathy | Placebo Oral Tablet | 28 | Participants | ||
| Number of Participants With Any Progression of Diabetic Retinopathy or Maculopathy Across the NHS Scotland Retinopathy Grading Scale | Fenofibrate 145 mg | 185 | Participants | ||
| Number of Participants With Any Progression of Diabetic Retinopathy or Maculopathy Across the NHS Scotland Retinopathy Grading Scale | Placebo Oral Tablet | 231 | Participants | ||
| Number of Participants With Referable Maculopathy (Exudates or Blot Haemorrhages Within One Disc Diameter of the Fovea) | Fenofibrate 145 mg | 107 | Participants | ||
| Number of Participants With Referable Maculopathy (Exudates or Blot Haemorrhages Within One Disc Diameter of the Fovea) | Placebo Oral Tablet | 149 | Participants |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Fenofibrate 145 mg | 576 | |
| Overall Study | STARTED | Placebo Oral Tablet | 575 | |
| Overall Study | COMPLETED | Fenofibrate 145 mg | 576 | |
| Overall Study | COMPLETED | Placebo Oral Tablet | 573 | |
| Overall Study | NOT COMPLETED | Fenofibrate 145 mg | 0 | |
| Overall Study | NOT COMPLETED | Placebo Oral Tablet | 2 |
Source ClinicalTrials.gov
Adverse events72
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Eye disorders | Eye disorders | Fenofibrate 145 mg | 2 | 576 | |
| other | Eye disorders | Eye disorders | Placebo Oral Tablet | 2 | 575 | |
| other | Gastrointestinal disorders | Gastrointestinal disorders | Fenofibrate 145 mg | 6 | 576 | |
| other | Gastrointestinal disorders | Gastrointestinal disorders | Placebo Oral Tablet | 5 | 575 | |
| other | Hepatobiliary disorders | Hepatobiliary disorders | Fenofibrate 145 mg | 0 | 576 | |
| other | Hepatobiliary disorders | Hepatobiliary disorders | Placebo Oral Tablet | 1 | 575 | |
| other | Investigations | Investigations | Fenofibrate 145 mg | 1 | 576 | |
| other | Investigations | Investigations | Placebo Oral Tablet | 3 | 575 | |
| other | Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | Fenofibrate 145 mg | 3 | 576 | |
| other | Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | Placebo Oral Tablet | 2 | 575 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fenofibrate 145 mg | 35 | 576 |
| Total, all-cause mortality | Placebo Oral Tablet | 38 | 575 |
| Total, other adverse events | Fenofibrate 145 mg | 17 | 576 |
| Total, other adverse events | Placebo Oral Tablet | 21 | 575 |
| Total, serious adverse events | Fenofibrate 145 mg | 208 | 576 |
| Total, serious adverse events | Placebo Oral Tablet | 204 | 575 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons23
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Fenofibrate 145 mg vs Placebo Oral Tablet: Number of Participants in Subgroup Age ≥60y With Progression to Referable Diabetic Retinopathy or Maculopathy, or Treatment. | Trial comparisons |
| Fenofibrate 145 mg vs Placebo Oral Tablet: Number of Participants in Subgroup With Progression to Referable Diabetic Retinopathy or Maculopathy, or Treatment, After 1 Year From Randomization | Trial comparisons |
| Fenofibrate 145 mg vs Placebo Oral Tablet: Number of Participants in Subgroup Sex - Male With Progression to Referable Diabetic Retinopathy or Maculopathy, or Treatment | Trial comparisons |
| Fenofibrate 145 mg vs Placebo Oral Tablet: Number of Participants With Occurrence of Major Cardiovascular Events (Myocardial Infarction, Stroke, Coronary or Peripheral Revascularisation) | Trial comparisons |
| Fenofibrate 145 mg vs Placebo Oral Tablet: Number of Participants in Subgroup - HbA1c ≥70 mmol/Mol With Progression to Referable Diabetic Retinopathy or Maculopathy, or Treatment | Trial comparisons |
| Fenofibrate 145 mg vs Placebo Oral Tablet: Number of Participants in Subgroup - eGFR ≥60 mL/Min/1.73m^2 With Progression to Referable Diabetic Retinopathy or Maculopathy, or Treatment | Trial comparisons |
| Fenofibrate 145 mg vs Placebo Oral Tablet: Number of Participants in Subgroup - Type 1 Diabetes With Progression to Referable Diabetic Retinopathy or Maculopathy, or Treatment | Trial comparisons |
| Fenofibrate 145 mg vs Placebo Oral Tablet: Number of Participants in Subgroup - HbA1c <70 mmol/Mol With Progression to Referable Diabetic Retinopathy or Maculopathy, or Treatment | Trial comparisons |
| Fenofibrate 145 mg vs Placebo Oral Tablet: Number of Participants With the Individual Component of Composite Primary Outcome: Treatment for Diabetic Retinopathy or Maculopathy | Trial comparisons |
| Fenofibrate 145 mg vs Placebo Oral Tablet: Number of Participants in Subgroup Sex - Female With Progression to Referable Diabetic Retinopathy or Maculopathy, or Treatment | Trial comparisons |
1 to 10 of 23
See all 23 trial comparisonsTests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03439345
GET https://conductscience.org/api/trials/v1/NCT03439345/registered?page=2