Trial · NCT03439345
Outcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 28
Download this page as JSON| 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 |
| SECONDARY | Cost to the Health Service | 2 years | Comparisons among all randomised participants of the effects of allocation to fenofibrate versus placebo over 2 years | GBP (British Pounds) | MEAN |
| SECONDARY | Cost-effectiveness (Incremental Cost Per QALY Gained) | Projected over 10 year horizon | QALY calculated based on quality of life data from EQ-5D questionnaires collected at baseline, at approximately 2 years and at the end of the trial. | Years gained | MEAN |
| SECONDARY | Number of Participants in Subgroup Sex - Male 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 in Subgroup Sex - Female 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 in Subgroup Age <60y 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 in Subgroup Age ≥60y 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 in Subgroup - Type 1 Diabetes 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 in Subgroup - Type 2 or Other Type of Diabetes 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 in Subgroup - eGFR <60 mL/Min/1.73m^2 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 in Subgroup - eGFR ≥60 mL/Min/1.73m^2 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 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03439345/outcomes