Diabetic RetinopathyNCT04885153
Effects of Oral Fenofibrate on Retinal Thickness and Macular Volume
A study testing Fenofibrate in people with Diabetic Retinopathy and Dyslipidemias, run by Universitas Indonesia.
Trial summary
Lipid levels in the blood are proposed to play a role in the progression of diabetic retinopathy. Lipid levels can be controlled with dyslipidemic drugs, such as fenofibrate. Fenofibrate is known to prevent diabetic microvascular complications by decreasing cholesterol and triglyceride levels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy, Dyslipidemias, Diabetes Mellitus
- What is being tested?
- Fenofibrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2016to 1 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with type 2 DM
- Confirmed DR (with bio-microscopy examination and fundus photos of both eyes)
- Dyslipidemia or normal lipid profile with treatment
- Sign informed consent
Who cannot join
- Subjects with severe renal failure
- Subjects with allergy towards fenofibrate
- Pregnant women
- Subjects who have undergone laser photocoagulation treatment or intravitreal injection in last 6 months
About this study
Official title: Effects of Oral Fenofibrate on Retinal Thickness and Macular Volume: Assessments on Retinal Endothelial Vascular Dysfunction, Inflammation, and Angiogenesis in Diabetic Retinopathy With Dyslipidemia
Lipid levels in the blood are proposed to play a role in the progression of diabetic retinopathy. Lipid levels can be controlled with dyslipidemic drugs, such as fenofibrate. Fenofibrate is known to prevent diabetic microvascular complications by decreasing cholesterol and triglyceride levels. This study aims to investigate the effects of oral fenofibrate on central macular thickness (CMT) and macular volume, as well as on specific biomarkers of endothelial dysfunction (eNOS), inflammation (VCAM-1), and angiogenesis (VEGF) in DR individuals with dyslipidemia.
Read the detailed description
This study was a prospective, double-blind, controlled clinical trial. The study was conducted from 2016 to 2017 at Vitreo-retina Clinic, Department of Ophthalmology, RSCM Kirana. The subjects were non-proliferative diabetic retinopathy (NPDR) patients with dyslipidemia or normal lipid profile with treatment. The outcome measures were central macular thickness (CMT), macular volume, endothelial nitric oxide (eNOS), vascular endothelial growth factor (VEGF), vascular cell adhesion molecule 1 (VCAM-1).
The operational definitions used in our study are as follows:
- Blood glucose control: glucose control status based on HbA1c levels within the last 3 month. Normal values < 7%.
- Dyslipidemia: patient is diagnosed with dyslipidemia if at least one out of four lipid profile parameters is above normal limits (LDL cholesterol ≥ 130, mg/dL, total cholesterol ≥ 200 mg/dL, HDL cholesterol < 40 mg/dL, triglyceride ≥ 150 mg/dL) or normal with treatment.
- Diabetic retinopathy: changes in retinal microvascular based on diabetic retinopathy classification
- Endothelial dysfunction: plasma endothelial nitric oxide (eNOS)
- Inflammation: plasma vascular endothelial growth factor (VEGF)
- Angiogenesis: plasma vascular cell adhesion molecule 1 (VCAM-1).
- Central macular thickness: thickness of fovea centralis based on OCT
- Macular volume: the volume of the retina in the central 6 mm of the macula
Subjects with severe renal failure, allergy towards fenofibrate, pregnant women, and subjects who have undergone laser photocoagulation treatment or intravitreal injection in last 6 months, were excluded. Subjects who did not take medication > 20% of scheduled drug doses were dropped out.
Subjects were allocated into two groups with block randomizations. Sample size calculation revealed a minimum sample size of 18 eyes. Subjects in intervention group received 18 mg of simvastatin and 200 mg of fenofibrate once daily for three months, and subjects in control group received 18 mg of simvastatin and placebo.
All subjects underwent eye examination, fundus photo, and macular spectral-domain optical coherence tomography (SD-OCT), as well as monthly blood and urine laboratory tests. All of the subjects were examined for their uncorrected visual acuity with Snellen chart, intraocular pressure, slitlamp biomicroscopy, and funduscopy through condensed 78 D lens. Fundus photo of both eyes of the subjects were taken before intervention, on every monthly follow-up during intervention, and at the end of study. Fundus photo was done using fundus digital camera (Kowa Medical Equipments, Japan). All fundus photos were read by two vitreo-retina consultants as independent readers. Evaluation of DR degree and the presence of diabetic macula edema (DME) was based on standard of ETDRS severity scale. Inter-reader reliability was also analyzed using Kappa coefficient calculation, which was considered to be acceptable if the value was more than 0.6.
Laboratory tests including HbA1c, triglycerides, total cholesterol, HDL cholesterol and LDL cholesterol, and specific eNOS, VEGF, and serum VCAM-1 biologic markers, were examined at baseline prior to drug administration, and at the end of the study after 3 months. In addition, at the beginning of the study, first, second and third month controls were examined for microalbuminuria, SGOT, SGPT, urine creatinine, blood urea, blood creatinine, and eGFR, to monitor the safety of drug delivery.
Data processing was done using IBM Statistic Program for Social Science (SPSS) version 20. All outcomes were numerical variables, comparison of numerical data between the two groups was performed with unpaired t-test if normal data distribution was fulfilled, otherwise non-parametric Mann Whitney test was used if the data was not normally distributed. To assess the difference between two paired data, Wilcoxon test was used.
- Conditions
- Diabetic Retinopathy, Dyslipidemias, Diabetes Mellitus
- Being tested
- Fenofibrate, Placebo
- Keywords
- diabetes mellitus, diabetic retinopathy, dyslipidemia, fenofibrate
- Medical subject headings
- Diabetic Retinopathy, Dyslipidemias, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FenofibrateDrug
Patients were given simvastatin 10 mg and fenofibrate 200 mg daily for three months and were evaluated monthly.
PlaceboDrug
Patients were given simvastatin 10 mg and placebo (lactic acid) 200 mg daily for three months and were evaluated monthly.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Subjects who were given simvastatin 10 mg and fenofibrate 200 mg. Receives: Drug: Fenofibrate |
| Control Group | Placebo comparator | Subjects who were given simvastatin 10 mg and placebo (lactic acid) 200 mg. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from Baseline Central Macular Thickness (CMT) at 3 Months
Thickness of fovea centralis based on OCT
Measured: Evaluated at baseline and monthly for three months
Changes from Baseline Macular Volume at 3 Months
Volume of the retina in the central 6 mm of the macula based on OCT
Measured: Evaluated at baseline and monthly for three months
Changes from Baseline Endothelial Nitric Oxide Synthase (eNOS) at 3 Months
Enzyme that produces protective molecule of the blood vessels
Measured: Evaluated at baseline and after three months (by the end of the study)
Changes from Baseline Vascular Endothelial Growth Factor (VEGF) at 3 Months
Signaling protein that promotes angiogenesis
Measured: Evaluated at baseline and after three months (by the end of the study)
Changes from Baseline Vascular Cell Adhesion Molecule-1 (VCAM -1) at 3 Months
Protein that functions for cell adhesion
Measured: Evaluated at baseline and after three months (by the end of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start1 Nov 2016
- Primary completion1 Jul 2017
- Study completion1 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were divided into two groups, which were intervention group (simvastatin+fenofibrate) and control group (simvastatin+placebo).
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gitalisa Andayani, Universitas Indonesia
- Investigators
- Gitalisa Andayani, MD, PhD, Principal investigator, Department of Ophthalmology, Cipto Mangunkusumo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04885153
- Sponsor's protocol ID
- FenofibrateRetinaGitalisa
- Status last verified
- May 2021
- First submitted
- 21 Jan 2021
- Last updated
- 13 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yau JW, Rogers SL, Kawasaki R, Lamoureux EL, Kowalski JW, Bek T, Chen SJ, Dekker JM, Fletcher A, Grauslund J, Haffner S, Hamman RF, Ikram MK, Kayama T, Klein BE, Klein R, Krishnaiah S, Mayurasakorn K, O'Hare JP, Orchard TJ, Porta M, Rema M, Roy MS, Sharma T, Shaw J, Taylor H, Tielsch JM, Varma R, Wang JJ, Wang N, West S, Xu L, Yasuda M, Zhang X, Mitchell P, Wong TY; Meta-Analysis for Eye Disease (META-EYE) Study Group. Global prevalence and major risk factors of diabetic retinopathy. Diabetes Care. 2012 Mar;35(3):556-64. doi: 10.2337/dc11-1909. Epub 2012 Feb 1.
PubMed 22301125Landmesser U, Hornig B, Drexler H. Endothelial dysfunction in hypercholesterolemia: mechanisms, pathophysiological importance, and therapeutic interventions. Semin Thromb Hemost. 2000;26(5):529-37. doi: 10.1055/s-2000-13209.
PubMed 11129409Xu J, Zou MH. Molecular insights and therapeutic targets for diabetic endothelial dysfunction. Circulation. 2009 Sep 29;120(13):1266-86. doi: 10.1161/CIRCULATIONAHA.108.835223. No abstract available.
PubMed 19786641Koshy J, Koshy JM, Thomas S, Kaur G, Mathew T. Should we start all patients with diabetic retinopathy on fenofibrates? Middle East Afr J Ophthalmol. 2013 Oct-Dec;20(4):309-14. doi: 10.4103/0974-9233.120012.
PubMed 24339680Keech AC, Mitchell P, Summanen PA, O'Day J, Davis TM, Moffitt MS, Taskinen MR, Simes RJ, Tse D, Williamson E, Merrifield A, Laatikainen LT, d'Emden MC, Crimet DC, O'Connell RL, Colman PG; FIELD study investigators. Effect of fenofibrate on the need for laser treatment for diabetic retinopathy (FIELD study): a randomised controlled trial. Lancet. 2007 Nov 17;370(9600):1687-97. doi: 10.1016/S0140-6736(07)61607-9. Epub 2007 Nov 7.
PubMed 17988728Noonan JE, Jenkins AJ, Ma JX, Keech AC, Wang JJ, Lamoureux EL. An update on the molecular actions of fenofibrate and its clinical effects on diabetic retinopathy and other microvascular end points in patients with diabetes. Diabetes. 2013 Dec;62(12):3968-75. doi: 10.2337/db13-0800.
PubMed 24264394Wright AD, Dodson PM. Medical management of diabetic retinopathy: fenofibrate and ACCORD Eye studies. Eye (Lond). 2011 Jul;25(7):843-9. doi: 10.1038/eye.2011.62. Epub 2011 Mar 25.
PubMed 21436845Massin P, Peto T, Ansquer JC, Aubonnet P, MacuFEN Study Investigators FT. Effects of fenofibric acid on diabetic macular edema: the MacuFen study. Ophthalmic Epidemiol. 2014 Oct;21(5):307-17. doi: 10.3109/09286586.2014.949783. Epub 2014 Aug 18.
PubMed 25133794Forstermann U, Sessa WC. Nitric oxide synthases: regulation and function. Eur Heart J. 2012 Apr;33(7):829-37, 837a-837d. doi: 10.1093/eurheartj/ehr304. Epub 2011 Sep 1.
PubMed 21890489Gustavsson C, Agardh CD, Zetterqvist AV, Nilsson J, Agardh E, Gomez MF. Vascular cellular adhesion molecule-1 (VCAM-1) expression in mice retinal vessels is affected by both hyperglycemia and hyperlipidemia. PLoS One. 2010 Sep 13;5(9):e12699. doi: 10.1371/journal.pone.0012699.
PubMed 20856927Hoeben A, Landuyt B, Highley MS, Wildiers H, Van Oosterom AT, De Bruijn EA. Vascular endothelial growth factor and angiogenesis. Pharmacol Rev. 2004 Dec;56(4):549-80. doi: 10.1124/pr.56.4.3.
PubMed 15602010Saxena S, Khatri M, Nadri G, Ankita. Pathogenic Mechanisms for Outer Retinal Layer Changes in Diabetic Retinopathy. Ann Diabetes Metab Disord Contr. 2017; 1:113.
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Fenofibrate on Retinal Thickness and Macular Volume: Assessments on Retinal Endothelial Vascular Dysfunction, Inflammation, and Angiogenesis in Diabetic Retinopathy With Dyslipidemia
- ClinicalTrials.gov ID
- NCT04885153
- Acronym / sponsor ID
- FenofibrateRetinaGitalisa
- Conditions
- Diabetic Retinopathy, Dyslipidemias, Diabetes Mellitus
- Keywords
- diabetes mellitus, diabetic retinopathy, dyslipidemia, fenofibrate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 1 Jul 2017 (actual)
- Study completion
- 1 Jul 2017 (actual)
- First posted
- 13 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lipid levels in the blood are proposed to play a role in the progression of diabetic retinopathy. Lipid levels can be controlled with dyslipidemic drugs, such as fenofibrate. Fenofibrate is known to prevent diabetic microvascular complications by decreasing cholesterol and triglyceride levels. This study aims to investigate the effects of oral fenofibrate on central macular thickness (CMT) and macular volume, as well as on specific biomarkers of endothelial dysfunction (eNOS), inflammation (VCAM-1), and angiogenesis (VEGF) in DR individuals with dyslipidemia.
Detailed description
This study was a prospective, double-blind, controlled clinical trial. The study was conducted from 2016 to 2017 at Vitreo-retina Clinic, Department of Ophthalmology, RSCM Kirana. The subjects were non-proliferative diabetic retinopathy (NPDR) patients with dyslipidemia or normal lipid profile with treatment. The outcome measures were central macular thickness (CMT), macular volume, endothelial nitric oxide (eNOS), vascular endothelial growth factor (VEGF), vascular cell adhesion molecule 1 (VCAM-1).
The operational definitions used in our study are as follows:
- Blood glucose control: glucose control status based on HbA1c levels within the last 3 month. Normal values < 7%.
- Dyslipidemia: patient is diagnosed with dyslipidemia if at least one out of four lipid profile parameters is above normal limits (LDL cholesterol ≥ 130, mg/dL, total cholesterol ≥ 200 mg/dL, HDL cholesterol < 40 mg/dL, triglyceride ≥ 150 mg/dL) or normal with treatment.
- Diabetic retinopathy: changes in retinal microvascular based on diabetic retinopathy classification
- Endothelial dysfunction: plasma endothelial nitric oxide (eNOS)
- Inflammation: plasma vascular endothelial growth factor (VEGF)
- Angiogenesis: plasma vascular cell adhesion molecule 1 (VCAM-1).
- Central macular thickness: thickness of fovea centralis based on OCT
- Macular volume: the volume of the retina in the central 6 mm of the macula
Subjects with severe renal failure, allergy towards fenofibrate, pregnant women, and subjects who have undergone laser photocoagulation treatment or intravitreal injection in last 6 months, were excluded. Subjects who did not take medication > 20% of scheduled drug doses were dropped out.
Subjects were allocated into two groups with block randomizations. Sample size calculation revealed a minimum sample size of 18 eyes. Subjects in intervention group received 18 mg of simvastatin and 200 mg of fenofibrate once daily for three months, and subjects in control group received 18 mg of simvastatin and placebo.
All subjects underwent eye examination, fundus photo, and macular spectral-domain optical coherence tomography (SD-OCT), as well as monthly blood and urine laboratory tests. All of the subjects were examined for their uncorrected visual acuity with Snellen chart, intraocular pressure, slitlamp biomicroscopy, and funduscopy through condensed 78 D lens. Fundus photo of both eyes of the subjects were taken before intervention, on every monthly follow-up during intervention, and at the end of study. Fundus photo was done using fundus digital camera (Kowa Medical Equipments, Japan). All fundus photos were read by two vitreo-retina consultants as independent readers. Evaluation of DR degree and the presence of diabetic macula edema (DME) was based on standard of ETDRS severity scale. Inter-reader reliability was also analyzed using Kappa coefficient calculation, which was considered to be acceptable if the value was more than 0.6.
Laboratory tests including HbA1c, triglycerides, total cholesterol, HDL cholesterol and LDL cholesterol, and specific eNOS, VEGF, and serum VCAM-1 biologic markers, were examined at baseline prior to drug administration, and at the end of the study after 3 months. In addition, at the beginning of the study, first, second and third month controls were examined for microalbuminuria, SGOT, SGPT, urine creatinine, blood urea, blood creatinine, and eGFR, to monitor the safety of drug delivery.
Data processing was done using IBM Statistic Program for Social Science (SPSS) version 20. All outcomes were numerical variables, comparison of numerical data between the two groups was performed with unpaired t-test if normal data distribution was fulfilled, otherwise non-parametric Mann Whitney test was used if the data was not normally distributed. To assess the difference between two paired data, Wilcoxon test was used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- Patients were divided into two groups, which were intervention group (simvastatin+fenofibrate) and control group (simvastatin+placebo).
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Drug: FenofibrateSubjects who were given simvastatin 10 mg and fenofibrate 200 mg. |
| Control Group | Placebo comparator | Drug: PlaceboSubjects who were given simvastatin 10 mg and placebo (lactic acid) 200 mg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults with type 2 DM
- Confirmed DR (with bio-microscopy examination and fundus photos of both eyes)
- Dyslipidemia or normal lipid profile with treatment
- Sign informed consent
Key exclusion criteria (4 listed)
- Subjects with severe renal failure
- Subjects with allergy towards fenofibrate
- Pregnant women
- Subjects who have undergone laser photocoagulation treatment or intravitreal injection in last 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FenofibratePatients were given simvastatin 10 mg and fenofibrate 200 mg daily for three months and were evaluated monthly. | Drug | Intervention Group |
| PlaceboPatients were given simvastatin 10 mg and placebo (lactic acid) 200 mg daily for three months and were evaluated monthly. | Drug | Control Group |
Primary outcome
Changes from Baseline Central Macular Thickness (CMT) at 3 Months
Time frame: Evaluated at baseline and monthly for three months
Thickness of fovea centralis based on OCT
Changes from Baseline Macular Volume at 3 Months
Time frame: Evaluated at baseline and monthly for three months
Volume of the retina in the central 6 mm of the macula based on OCT
Changes from Baseline Endothelial Nitric Oxide Synthase (eNOS) at 3 Months
Time frame: Evaluated at baseline and after three months (by the end of the study)
Enzyme that produces protective molecule of the blood vessels
Changes from Baseline Vascular Endothelial Growth Factor (VEGF) at 3 Months
Time frame: Evaluated at baseline and after three months (by the end of the study)
Signaling protein that promotes angiogenesis
Changes from Baseline Vascular Cell Adhesion Molecule-1 (VCAM -1) at 3 Months
Time frame: Evaluated at baseline and after three months (by the end of the study)
Protein that functions for cell adhesion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
- Background: PubMed 22301125Yau JW, Rogers SL, Kawasaki R, Lamoureux EL, Kowalski JW, Bek T, Chen SJ, Dekker JM, Fletcher A, Grauslund J, Haffner S, Hamman RF, Ikram MK, Kayama T, Klein BE, Klein R, Krishnaiah S, Mayurasakorn K, O'Hare JP, Orchard TJ, Porta M, Rema M, Roy MS, Sharma T, Shaw J, Taylor H, Tielsch JM, Varma R, Wang JJ, Wang N, West S, Xu L, Yasuda M, Zhang X, Mitchell P, Wong TY; Meta-Analysis for Eye Disease (META-EYE) Study Group. Global prevalence and major risk factors of diabetic retinopathy. Diabetes Care. 2012 Mar;35(3):556-64. doi: 10.2337/dc11-1909. Epub 2012 Feb 1.
- Background: PubMed 11129409Landmesser U, Hornig B, Drexler H. Endothelial dysfunction in hypercholesterolemia: mechanisms, pathophysiological importance, and therapeutic interventions. Semin Thromb Hemost. 2000;26(5):529-37. doi: 10.1055/s-2000-13209.
- Background: PubMed 19786641Xu J, Zou MH. Molecular insights and therapeutic targets for diabetic endothelial dysfunction. Circulation. 2009 Sep 29;120(13):1266-86. doi: 10.1161/CIRCULATIONAHA.108.835223. No abstract available.
- Background: PubMed 24339680Koshy J, Koshy JM, Thomas S, Kaur G, Mathew T. Should we start all patients with diabetic retinopathy on fenofibrates? Middle East Afr J Ophthalmol. 2013 Oct-Dec;20(4):309-14. doi: 10.4103/0974-9233.120012.
- Background: PubMed 17988728Keech AC, Mitchell P, Summanen PA, O'Day J, Davis TM, Moffitt MS, Taskinen MR, Simes RJ, Tse D, Williamson E, Merrifield A, Laatikainen LT, d'Emden MC, Crimet DC, O'Connell RL, Colman PG; FIELD study investigators. Effect of fenofibrate on the need for laser treatment for diabetic retinopathy (FIELD study): a randomised controlled trial. Lancet. 2007 Nov 17;370(9600):1687-97. doi: 10.1016/S0140-6736(07)61607-9. Epub 2007 Nov 7.
- Background: PubMed 24264394Noonan JE, Jenkins AJ, Ma JX, Keech AC, Wang JJ, Lamoureux EL. An update on the molecular actions of fenofibrate and its clinical effects on diabetic retinopathy and other microvascular end points in patients with diabetes. Diabetes. 2013 Dec;62(12):3968-75. doi: 10.2337/db13-0800.
- Background: PubMed 21436845Wright AD, Dodson PM. Medical management of diabetic retinopathy: fenofibrate and ACCORD Eye studies. Eye (Lond). 2011 Jul;25(7):843-9. doi: 10.1038/eye.2011.62. Epub 2011 Mar 25.
- Background: PubMed 25133794Massin P, Peto T, Ansquer JC, Aubonnet P, MacuFEN Study Investigators FT. Effects of fenofibric acid on diabetic macular edema: the MacuFen study. Ophthalmic Epidemiol. 2014 Oct;21(5):307-17. doi: 10.3109/09286586.2014.949783. Epub 2014 Aug 18.
- Background: PubMed 21890489Forstermann U, Sessa WC. Nitric oxide synthases: regulation and function. Eur Heart J. 2012 Apr;33(7):829-37, 837a-837d. doi: 10.1093/eurheartj/ehr304. Epub 2011 Sep 1.
- Background: PubMed 20856927Gustavsson C, Agardh CD, Zetterqvist AV, Nilsson J, Agardh E, Gomez MF. Vascular cellular adhesion molecule-1 (VCAM-1) expression in mice retinal vessels is affected by both hyperglycemia and hyperlipidemia. PLoS One. 2010 Sep 13;5(9):e12699. doi: 10.1371/journal.pone.0012699.
- Background: PubMed 15602010Hoeben A, Landuyt B, Highley MS, Wildiers H, Van Oosterom AT, De Bruijn EA. Vascular endothelial growth factor and angiogenesis. Pharmacol Rev. 2004 Dec;56(4):549-80. doi: 10.1124/pr.56.4.3.
- BackgroundSaxena S, Khatri M, Nadri G, Ankita. Pathogenic Mechanisms for Outer Retinal Layer Changes in Diabetic Retinopathy. Ann Diabetes Metab Disord Contr. 2017; 1:113.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gitalisa Andayani, MD, PhD principal investigator
Department of Ophthalmology, Cipto Mangunkusumo Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Fenofibrate in people with Diabetic Retinopathy and Dyslipidemias, run by Universitas Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from Baseline Central Macular Thickness (CMT) at 3 Months (time frame: Evaluated at baseline and monthly for three months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04885153, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2021.