journal

1. Journal Club
By
Dr. K.Anudeep
Moderator
Prof. Dr. K.Srikanth

2. EFFICIENCY OF FENOFIBRATE IN FACILITATING THE
REDUCTION OF CENTRAL MACULAR THICKNESS IN
DIABETIC MACULAR EDEMA
 Published in Indian Journal of Ophthalmology in
September 2017
 The purpose of the study was to study the benefit of
addition of oral fenofibrate to the current regimen of
diabetic macular edema management and quantify
its effect on macular thickness and visual function
in diabetic macular edema.

3. FENOFIBRATE
 Peroxisome proliferator activated receptor alpha agonist
 PPARα – therapeutic target in diabetic vascular damage
 Used in hypertriglyceridemia and dyslipidemia.
 Fenofibrate converts to fibric acid in plasma and
stimulates PPARα
 Supress AMP-activated protein kinase – prevents
apoptosis
 Upregulates expression of apo A1 in liver – intraretinal
reverse transport of lipids.
 Decrease SP1 activity – decreases VEGF signalling
 Anti-inflammatory effects including the modulation of the
expression of several cytokines.
 Improves endothelial function.

4.  Design - Prospective randomized controlled trial
 Includes 53 eyes of 50 patients with diabetic
macular edema. Divided into 2 groups.
 Group A – 28 eyes of 25 patients (22 patients had
DME in one eye and 3 patients had DME in both
eyes)
 Group B – 25 eyes of 25 patients (DME in one eye)
 Mean age in group A was 60.16 yrs and group B
was 59.40 yrs. Duration of diabetes 5-15 yrs.
 Patients were followed up for every 2 months for a
period of 6 months.

5. METHODS
 Inclusion criteria :
 1. CMT measured on stratus OCT equal to or more
than 250µ.
 2. HbA1c <9
 3. Normal creatinine levels
 Systolic BP <140/90 mmHg.

6.  Exclusion criteria :
 Abnormal renal parameters.
 Known liver disease
 Media opacities preventing good macular
evaluation
 Macular ischaemia, foveal hard exudates
 Coexisting macular disease other than DME
 High risk PDR and treated previously with laser
photocoagulation or intravitreal injections.

7. METHODOLOGY
 Informed written consent
 Complete ophthalmic examination
 FFA and stratus OCT
 Complete physical evaluation and blood
parameters

9.  All patients underwent treatment with intravitreal
anti-VEGF and one session of grid/focal laser
photocoagulation was given in leaking areas as
seen on FFA
 Patients were given a trial of topical steroids for
steroid responsiveness before IVTA and followed
up for the same.
 Patients in group A were in addition given oral
fenofibrate 160mg/day for 6 months as a single
evening dose.

10.  Qualitative data were analyzed by Chi-square test,
Mann-Whitney test and students t-test.
 Statistical significance fixed at P < 0.05 with 95%
confidence interval.

11. RESULTS

12. COMPARATIVE ANALYSIS OF TREATMENT
OUTCOMES IN CASE AND CONTROL GROUPS
EFFECT ON CENTRAL MACULAR THICKNESS :

13. EFFECT ON VISUAL ACUITY :

15. HIGHLIGHTS
 This study shows addition of fenofibrate in the
management protocol for DME improves reduction
of CMT and improvement in visual acuity
significantly.
 Irrespective of triglyceride, hypertensive and
diabetic retinopathy status.
 Improvement in functional and anatomical outcome.
 No adverse effects
 Continued reduction of CMT over a period of 6
months.

16.  FIELD study – requirement for the laser was
significantly lower in the fenofibrate group.
 Progression in retinopathy was significantly lower in
preexisting retinopathy.
 ACCORD eye study – reduction in progression of
retinopathy independent of glycaemia.
 Higher stage of diabetic retinopathy showed higher
benefit with addition of fenofibrate.

17. DEMERITS
 Very small sample size, shorter follow up
 Randomisation not done properly
 Methodology – not mentioned about dosage of anti-
VEGF
 Multiple modalities of treatment – Anti VEGF, IVTA, laser
photocoagulation.
 Results – within the control group not mentioned about
the results in PDR, NPDR, focal and diffuse edema.
 Severity of retinopathy not mentioned
 Difference in improvement in visual acuity and CMT in
both groups although significant, not large enough and
is difficult to interpret how much is this due to addition of
fenofibrate.
 Follow up after 6 months and treatment with fenofibrate
after 6 months continued or not is not mentioned.

18. FUTURE DIRECTION
 Large sample size
 Multi center studies
 Long term follow up
 Spectral domain OCT instead of time domain OCT.

19. TAKE HOME MESSAGE
 This study shows improvement in CMT and visual
acuity with fenofibrate, further research needs to be
done with more sample size and more severity of
edema.