fenofibrate and Central Retinal Edema, Cystoid studies

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Research Excerpts

Excerpt	Relevance	Reference
"Current, moderate-certainty evidence suggests that in a mixed group of people with and without overt retinopathy, who live with T2D, fenofibrate likely results in little to no difference in progression of diabetic retinopathy."	9.41	Fenofibrate for diabetic retinopathy. ( Inoue, K; Kataoka, SY; Kataoka, Y; Kawano, S; Lois, N; Watanabe, N, 2023)
"The purpose of this study is to study the benefit of addition of oral fenofibrate to the current regimen of diabetic macular edema (DME) management and quantify its effect on macular thickness and visual function in DME."	9.27	Efficiency of fenofibrate in facilitating the reduction of central macular thickness in diabetic macular edema. ( Hande, P; Murali, S; Shetty, J; Srinivasan, S, 2018)
"Fenofibrate reduced progression of diabetic retinopathy in two large randomized studies."	9.19	Effects of fenofibric acid on diabetic macular edema: the MacuFen study. ( Ansquer, JC; Aubonnet, P; MacuFEN Study Investigators, FT; Massin, P; Peto, T, 2014)
"Treatment with fenofibrate in individuals with type 2 diabetes mellitus reduces the need for laser treatment for diabetic retinopathy, although the mechanism of this effect does not seem to be related to plasma concentrations of lipids."	9.12	Effect of fenofibrate on the need for laser treatment for diabetic retinopathy (FIELD study): a randomised controlled trial. ( Colman, PG; Crimet, DC; d'Emden, MC; Davis, TM; Keech, AC; Laatikainen, LT; Merrifield, A; Mitchell, P; Moffitt, MS; O'Connell, RL; O'Day, J; Simes, RJ; Summanen, PA; Taskinen, MR; Tse, D; Williamson, E, 2007)
"To assess the association between fenofibrate use and the progression from NPDR to VTDR, proliferative DR (PDR), or diabetic macular edema (DME)."	8.12	Association of Fenofibrate Use and the Risk of Progression to Vision-Threatening Diabetic Retinopathy. ( Bavinger, JC; Meer, E; VanderBeek, BL; Yu, Y, 2022)
"Numerous studies have reported the efficacy of fenofibrate for patients with diabetic retinopathy (DRP)."	7.91	Efficacy of fenofibrate for diabetic retinopathy: A systematic review protocol. ( Han, L; Liu, HW; Qi, YX; Su, XJ, 2019)
"Current, moderate-certainty evidence suggests that in a mixed group of people with and without overt retinopathy, who live with T2D, fenofibrate likely results in little to no difference in progression of diabetic retinopathy."	5.41	Fenofibrate for diabetic retinopathy. ( Inoue, K; Kataoka, SY; Kataoka, Y; Kawano, S; Lois, N; Watanabe, N, 2023)
"The purpose of this study is to study the benefit of addition of oral fenofibrate to the current regimen of diabetic macular edema (DME) management and quantify its effect on macular thickness and visual function in DME."	5.27	Efficiency of fenofibrate in facilitating the reduction of central macular thickness in diabetic macular edema. ( Hande, P; Murali, S; Shetty, J; Srinivasan, S, 2018)
"Fenofibrate reduced progression of diabetic retinopathy in two large randomized studies."	5.19	Effects of fenofibric acid on diabetic macular edema: the MacuFen study. ( Ansquer, JC; Aubonnet, P; MacuFEN Study Investigators, FT; Massin, P; Peto, T, 2014)
"Treatment with fenofibrate in individuals with type 2 diabetes mellitus reduces the need for laser treatment for diabetic retinopathy, although the mechanism of this effect does not seem to be related to plasma concentrations of lipids."	5.12	Effect of fenofibrate on the need for laser treatment for diabetic retinopathy (FIELD study): a randomised controlled trial. ( Colman, PG; Crimet, DC; d'Emden, MC; Davis, TM; Keech, AC; Laatikainen, LT; Merrifield, A; Mitchell, P; Moffitt, MS; O'Connell, RL; O'Day, J; Simes, RJ; Summanen, PA; Taskinen, MR; Tse, D; Williamson, E, 2007)
"To assess the association between fenofibrate use and the progression from NPDR to VTDR, proliferative DR (PDR), or diabetic macular edema (DME)."	4.12	Association of Fenofibrate Use and the Risk of Progression to Vision-Threatening Diabetic Retinopathy. ( Bavinger, JC; Meer, E; VanderBeek, BL; Yu, Y, 2022)
"Numerous studies have reported the efficacy of fenofibrate for patients with diabetic retinopathy (DRP)."	3.91	Efficacy of fenofibrate for diabetic retinopathy: A systematic review protocol. ( Han, L; Liu, HW; Qi, YX; Su, XJ, 2019)
"There is clinical evidence that fenofibrate, a PPARα agonist, arrests the progression of diabetic macular edema (DME)."	3.83	Fenofibrate prevents the disruption of the outer blood retinal barrier through downregulation of NF-κB activity. ( Garcia-Ramírez, M; Hernández, C; Palomer, X; Simó, R; Vázquez-Carrera, M, 2016)

Research

Studies (12)

Authors

Clinical Trials (3)

Trial Overview

Trial Outcomes

Death From Any Cause in the Glycemia Trial.

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	3 (25.00)	29.6817
2010's	7 (58.33)	24.3611
2020's	2 (16.67)	2.80

Authors	Studies
Meer, E	1
Bavinger, JC	1
Yu, Y	1
VanderBeek, BL	1
Kataoka, SY	1
Lois, N	1
Kawano, S	1
Kataoka, Y	1
Inoue, K	1
Watanabe, N	1
Srinivasan, S	1
Hande, P	1
Shetty, J	1
Murali, S	1
Su, XJ	1
Han, L	1
Qi, YX	1
Liu, HW	1
Massin, P	1
Peto, T	1
Ansquer, JC	1
Aubonnet, P	1
MacuFEN Study Investigators, FT	1
Chew, EY	1
Davis, MD	1
Danis, RP	1
Lovato, JF	1
Perdue, LH	1
Greven, C	1
Genuth, S	1
Goff, DC	1
Leiter, LA	1
Ismail-Beigi, F	1
Ambrosius, WT	1
Zhang, C	1
Wang, H	1
Nie, J	1
Wang, F	1
Garcia-Ramírez, M	2
Hernández, C	4
Palomer, X	1
Vázquez-Carrera, M	1
Simó, R	4
Villarroel, M	1
Corraliza, L	1
Keech, AC	1
Mitchell, P	1
Summanen, PA	1
O'Day, J	1
Davis, TM	1
Moffitt, MS	1
Taskinen, MR	1
Simes, RJ	1
Tse, D	1
Williamson, E	1
Merrifield, A	1
Laatikainen, LT	1
d'Emden, MC	1
Crimet, DC	1
O'Connell, RL	1
Colman, PG	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Effects of Oral Fenofibrate on Retinal Thickness and Macular Volume: Assessments on Retinal Endothelial Vascular Dysfunction, Inflammation, and Angiogenesis in Diabetic Retinopathy With Dyslipidemia[NCT04885153]		36 participants (Actual)	Interventional	2016-11-01	Completed
Action to Control Cardiovascular Risk in Diabetes (ACCORD)[NCT00000620]	Phase 3	10,251 participants (Actual)	Interventional	1999-09-30	Completed
Action to Control Cardiovascular Risk in Diabetes (ACCORD) Eye Study[NCT00542178]	Phase 3	3,472 participants (Actual)	Interventional	2003-10-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

"Time to death from any cause. Secondary measure for Glycemia Trial.~A finding of higher mortality in the intensive-therapy group led to an early discontinuation of therapy after a mean of 3.5 years of follow-up. Intensive arm participants were transitioned to standard arm strategy over a period of 0.2 year and followed for an additional 1.2 years to the planned end of the Glycemia Trial while participating in one of the other sub-trials (BP or Lipid)." (NCT00000620)
Timeframe: 4.9 years

First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial.

Intervention	participants (Number)
Glycemia Trial: Intensive Control	391
Glycemia Trial: Standard Control	327

"Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. This was the primary outcome measure in all three trials: Glycemia (all participants), Blood Pressure (subgroup of participants not in Lipid Trial), and Lipid (subgroup of participants not in Blood Pressure Trial).~In the Glycemia Trial, a finding of higher mortality in the intensive arm group led to an early discontinuation of therapy after a mean of 3.5 years of follow-up. Intensive arm participants were transitioned to standard arm strategy over a period of 0.2 year and followed for an additional 1.2 years to the planned end of the Glycemia Trial while participating in one of the other sub-trials (BP or Lipid) to their planned completion." (NCT00000620)
Timeframe: 4.9 years

First Occurrence of Major Cardiovascular Event (MCE) in the Blood Pressure Trial.

Intervention	participants (Number)
Glycemia Trial: Intensive Control	503
Glycemia Trial: Standard Control	543

Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. Primary outcome for Blood Pressure Trial. (NCT00000620)
Timeframe: 4.7 years

First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial.

Intervention	participants (Number)
BP Trial: Intensive Control	208
BP Trial: Standard Control	237

Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death in Lipid Trial participants. (NCT00000620)
Timeframe: 4.7 years

First Occurrence of MCE or Revascularization or Hospitalization for Congestive Heart Failure (CHF) in Lipid Trial.

Intervention	participants (Number)
Lipid Trial: Fenofibrate	291
Lipid Trial: Placebo	310

Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, cardiovascular death, revascularization procedure or hospitalization for CHF in Lipid Trial participants. (NCT00000620)
Timeframe: 4.7 years

Stroke in the Blood Pressure Trial.

Intervention	participants (Number)
Lipid Trial: Fenofibrate	641
Lipid Trial: Placebo	667

Time to first occurrence of nonfatal or fatal stroke among participants in the BP Trial. (NCT00000620)
Timeframe: 4.7 years

Cataract Extraction

Development or Progression of Macular Edema

Loss of Visual Acuity

Number of Participants With Progression of Diabetic Retinopathy of at Least 3 Stages on the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale, or Development of Proliferative Diabetic Retinopathy Necessitating Photocoagulation Therapy or Vitrectomy

Intervention	participants (Number)
BP Trial: Intensive Control	36
BP Trial: Standard Control	62

Intervention	Participants (Count of Participants)
Intensive Glycemia Control	547
Standard Glycemia Control	623
Intensive Blood Pressure Control	266
Standard Blood Pressure Control	300
Fenofibrate + Simvastatin Therapy	305
Placebo + Simvastatin Therapy	299

Intervention	Participants (Count of Participants)
Intensive Glycemia Control	44
Standard Glycemia Control	40
Intensive Blood Pressure Control	18
Standard Blood Pressure Control	20
Fenofibrate + Simvastatin Therapy	24
Placebo + Simvastatin Therapy	22

Intervention	Participants (Count of Participants)
Intensive Glycemia Control	744
Standard Glycemia Control	752
Intensive Blood Pressure Control	367
Standard Blood Pressure Control	382
Fenofibrate + Simvastatin Therapy	354
Placebo + Simvastatin Therapy	393

Diabetic retinopathy status was defined according to the eye with the highest level on the ETDRS Final Severity Scale for Persons, as follows: no diabetic retinopathy, a level of less than 20; mild diabetic retinopathy, a level of 20; moderate nonproliferative diabetic retinopathy (NPDR), a level above 20 but less than 53; severe diabetic retinopathy, a level of 53 but less than 60; and proliferative diabetic retinopathy (PDR), a level of 60 or higher. (NCT00542178)
Timeframe: Measured at Year 4

Article	Year
Fenofibrate for diabetic retinopathy. The Cochrane database of systematic reviews, 2023, 06-13, Volume: 6 Topics: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetic Retinopathy; Fenofibrate; Humans; Mac	2023
Protective factors in diabetic retinopathy: focus on blood-retinal barrier. Discovery medicine, 2014, Volume: 18, Issue:98 Topics: Animals; Blood-Retinal Barrier; Diabetic Retinopathy; Erythropoietin; Fenofibrate; Humans; Insulin-L	2014
Advances in the medical treatment of diabetic retinopathy. Diabetes care, 2009, Volume: 32, Issue:8 Topics: Blindness; Blood-Retinal Barrier; Cholesterol, HDL; Cholesterol, LDL; Diabetes Mellitus, Type 1; Dia	2009

Article	Year
Association of Fenofibrate Use and the Risk of Progression to Vision-Threatening Diabetic Retinopathy. JAMA ophthalmology, 2022, 05-01, Volume: 140, Issue:5 Topics: Aged; Cohort Studies; Diabetes Mellitus, Type 2; Diabetic Retinopathy; Female; Fenofibrate; Humans;	2022
Efficacy of fenofibrate for diabetic retinopathy: A systematic review protocol. Medicine, 2019, Volume: 98, Issue:14 Topics: Diabetic Retinopathy; Disease Progression; Fenofibrate; Humans; Hypolipidemic Agents; Macular Edema;	2019
Fenofibrate prevents the disruption of the outer blood retinal barrier through downregulation of NF-κB activity. Acta diabetologica, 2016, Volume: 53, Issue:1 Topics: Blood-Retinal Barrier; Capillary Permeability; Cells, Cultured; Cytokines; Diabetic Retinopathy; Dow	2016
Fenofibric acid prevents retinal pigment epithelium disruption induced by interleukin-1β by suppressing AMP-activated protein kinase (AMPK) activation. Diabetologia, 2011, Volume: 54, Issue:6 Topics: Aged; AMP-Activated Protein Kinases; Biological Transport; Blood-Retinal Barrier; Cell Line; Cell Me	2011

fenofibrate and Central Retinal Edema, Cystoid