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Clinical Ophthalmology 2018:12 1205–1211
Clinical Ophthalmology Dovepress
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ORIGINAL RESEARCH
open access to scientific and medical research
Open Access Full Text Article
http://dx.doi.org/10.2147/OPTH.S163681
Macular edema resolution assessment with
implantable dexamethasone in diabetic retinopathy
(MERIT): a pilot study
Jay Chhablani
Mahima Jhingan
Abhilash Goud
Kiran Kumar Vupparaboina
Taraprasad Das
Smt Kanuri Santhamma Retina
Vit reous Centre, LV Prasad Eye
Institute, Hyderabad, Telangana, India
Purpose: This study aimed to evaluate the effect of dexamethasone implantation on the hard
exudates (HEX) in patients with diabetic macular edema (DME).
Study design: This was a nonrandomized open-label single-center prospective trial.
Methods: This study included 15 eyes of 11 subjects with DME. Key inclusion criteria were
naïve eyes with DME with HEX within 3 mm of fovea with center-involving DME; central
macular thickness (CMT) .250 μm at baseline; best-corrected visual acuity (BCVA) between
20/400 and 20/40. Key exclusion criteria were previous intraocular surgery and history of
panretinal photocoagulation (PRP) in past 4 months. The primary outcome measure was change
in total HEX area at the macula (in mm2) measured by semiautomated algorithm. Secondary
outcome measures were change in visual acuity, low-contrast visual acuity (LCVA), retinal
sensitivity (RS) on macular microperimetry, and CMT.
Results: The total HEX area reduced from 1.5 mm2 (±1.46 mm2) at baseline to 0.89 mm2
(±1.062 mm2) at the final visit (p=0.185). The CMT improved significantly (p=0.03) from
488.67 μm (±240.66 μm) to 326.93 μm (±135.84 μm) at the final visit. Mean BCVA remained
stable ( p=0.95) (50.93±16.65 at baseline and 50.6±18.95 at final visit). The mean LCVA and
RS showed insignificant improvement ( p=0.31 and p=0.28, respectively).
Conclusion: Our pilot study demonstrated an improving trend in reduction of total HEX area
and other anatomical outcomes, with limited functional outcomes. Larger randomized studies
with a larger sample size with a control group are warranted to establish management protocols
for DME with significant subfoveal HEX.
Keywords: dexamethasone implant, Ozurdex, hard exudates, diabetic macular edema
Introduction
Diabetic macular edema (DME) constitutes a significant burden owing to the prolonged
and varied response to treatment. DME results mainly from hyperpermeability
of retinal vessels and microaneurysms associated with deposition of lipoproteins,
clinically manifesting as hard exudates (HEX), mostly deposited in the posterior pole,
often signifying the chronicity of the edema.1 Subfoveal migration of HEX could be
a challenging situation, with very poor visual outcome due to outer retinal structure
damage and may lead to subretinal fibrosis.
Various approaches, including laser photocoagulation, anti-vascular endothelial
growth factor (VEGF) therapy, surgical removal, and intravitreal triamcinolone have
been used to manage extensive HEX.2–7 Each of the treatment modalities has its chal-
lenges, such as the associated complications and limitations. Anti-VEGF therapy
has shown promising results in terms of both anatomical and visual outcomes and
Correspondence: Jay Chhablani
Smt Kanuri Santhamma Retina Vitreous
Centre, LV Prasad Eye Institute, Kallam
Anji Reddy Campus, 2 LV Prasad Marg
Banjara Hills, Hyderabad 500034,
Telangana, India
Tel +91 40 3061 2603
Fax +91 40 2354 8271
Email jay.chhablani@gmail.com
Journal name: Clinical Ophthalmology
Article Designation: Original Research
Year: 2018
Volume: 12
Running head verso: Chhablani et al
Running head recto: Hard exudates and dexamethasone implant
DOI: 163681
This article was published in the following Dove Press journal:
Clinical Ophthalmology
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Chhablani et al
has rapidly become the standard of care after pivotal trials
such as the RISE and RIDE.8 However, rapid reduction of
DME is associated with an increase in intraretinal exudates,
along with a shift to a more outer retinal location.9 On the
other hand, the RIDE and RISE trials have demonstrated
that the area of HEX in eyes with DME did not affect visual
prognosis and that HEX did not increase in ranibizumab-
treated eyes.10
Considering that DME could primarily be an inflam-
matory pathological process, intravitreal steroids have
also been used, and these have shown promising results
in the reduction of HEX and edema over a short term of
follow-up.4–6,11 Intravitreal triamcinolone is associated with
various possible complications such as endophthalmitis and
intractable glaucoma.12 The 2-year results of the Bevaci-
zumab or Dexamethasone Implants for DME (BEVORDEX)
study showed a reduction of HEX in patients with DME with
both intravitreal dexamethasone and bevacizumab, although
the reduction of HEX in center-involving DME (,500 μm)
was statistically significant with dexamethasone only.13
Many large-scale clinical trials such as protocol T14 did
not include eyes with extensive exudates involving foveal
area; therefore, clinicians lack any established protocol to
treat such cases. We designed a pilot study to document the
effect of continuous release of dexamethasone (using an
implantable device) on the HEX at fovea (primary objec-
tive) in patients with DME and to quantify the same. The
secondary objective was to study the functional impact of
implantable dexamethasone on the contrast sensitivity and
macular function.
Methods
A nonrandomized open-label single-center prospective con-
trolled trial was conducted on 15 eyes of 11 subjects with
a diagnosis of DME who presented to the LV Prasad Eye
Institute between April 2015 and February 2016. Written
informed consent was obtained from all subjects. The institu-
tional review board of Hyderabad Eye Research Foundation
approved the study (LEC12-14-109), and all the procedures
adhered to the tenets of the Declaration of Helsinki. The chart
review followed the previously set out guidelines, described
in earlier publications.15
Key inclusion criteria for the study were as follows:
1) naïve eyes with DME with HEX within 3 mm of fovea
with center-involving DME; 2) diagnosis of diabetes mellitus
(type 1 or type 2); 3) central foveal thickness .250 μm
at baseline; and 4) best-corrected visual acuity (BCVA)
between 20/400 and 20/40. The exclusion criteria included
the following: 1) any other associated ocular condition;
2) macular edema due to any other condition; 3) presence of
conditions such as macular ischemia, vitreomacular traction,
foveal atrophy, or pigment abnormalities; 4) substantial cata-
ract likely to decrease visual acuity by $3 lines; 5) history
of treatment for DME at any time; 6) history of panretinal
(scatter) photocoagulation (PRP) within 4 months prior
to enrollment; 7) history of major ocular surgery (includ-
ing vitrectomy, cataract extraction, scleral buckle, any
intraocular surgery, and so on) within the previous 4 months
or anticipated within the next 6 months following enrollment;
8) history of yttrium aluminum garnet (YAG) capsulotomy
performed within 2 months prior to enrollment; 9) aphakia;
10) intraocular pressure (IOP) $25 mmHg; 11) history
of open-angle glaucoma; 12) history of steroid-induced
IOP elevation that required IOP-lowering treatment; and
13) examination evidence of external ocular infection, includ-
ing conjunctivitis, chalazion, or significant blepharitis.
Data collected at the initial visit included demographics,
BCVA using the Early Treatment Diabetic Retinopathy Study
(ETDRS) visual acuity, low-contrast visual acuity (LCVA)
using COMPLog, color fundus photographs (7 fields),
infrared images (7 fields), autofluorescence images (7 fields),
optical coherence tomography (OCT) with central macular
thickness (CMT), fundus fluorescein angiography (FFA),
and microperimetry.
A comprehensive ocular examination was performed in
all cases. Ocular investigations included OCT and FFA. FFA
and fundus photography were performed using FF450 plus
Fundus Camera (Carl Zeiss, Jena, Germany) with VISUPAC.
Lens grading was performed as per standard Emery and
Little classification.16 Patients were not treated aggressively
with lipid-lowering medications, other than their regular
medications.
Color fundus photographs
Color fundus photographs (50° and 30°) were captured in
7 fields with a mydriatic fundus camera (Zeiss FF450; Carl
Zeiss Meditec).
FFA study
FFA was performed using fluorescein sodium 20%, and
imaging was performed using FF450 plus Fundus Camera
(Carl Zeiss Meditec) with VISUPAC in all visits.
Spectral domain OCT (SD-OCT)
The SD-OCT scans were obtained using Cirrus HD-OCT
(Carl Zeiss Meditec) after dilatation of the pupil with 0.8%
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Hard exudates and dexamethasone implant
tropicamide and 5% phenylephrine eye drops at every visit.
The scanning protocol included high-definition (HD) 5-line
raster, HD single-line raster, enhanced depth imaging, and
macular cube. Central retinal thickness (CRT) was deter-
mined automatically and analyzed by OCT software, by
generating images using the Macular Cube 512×128 scan
over a 6×6 mm area, the cube being composed of 128 hori-
zontal examination lines of 512 A-scans each. The CRT was
obtained from the 1 mm CRT area as described in the ETDRS
fields corresponding to the CMT.
Microperimetry
Microperimetry was performed using the microperim-
eter (macular integrity assessment [MAIA™]; CenterVue,
Padova, Italy). Pupils of all patients were dilated before
examination. Goldmann III stimuli and a 4-2-1 staircase
strategy were used, and a test grid with 37 stimulus locations
covering an area of 10° was applied. The stimuli were pro-
jected on a white background with black illumination set to
1.27 cd/m2 and a stimulus presentation time of 200 ms. The
perimetric strategy of the microperimeter starts at an initially
defined threshold level for each stimulus. A 4-2-1 staircase
strategy is then carried out, and the weakest recognized value
is documented as the retinal sensitivity (RS) at each tested
site. Mean differential light sensitivity, in decibels (dB), of all
test locations was analyzed for the study. For assessment of
fixation, the fundus movements were tracked during exami-
nation while the patient gazed at the fixation target. The auto
tracking system calculated the horizontal and vertical shifts
relative to a reference frame and drew a map of the patient’s
eye movements during the examination. The recorded
fixation points were classified into 3 categories for fixation
analysis – stable, relatively unstable, and unstable. Fixation
was defined as follows: stable if .75% of the fixation
points were inside the 2°-diameter circle; relatively unstable
if ,75% were inside the 2°-diameter circle, but .75% were
inside the 4°-diameter circle; and unstable if ,75% of the
fixation sites were inside the 4°-diameter circle. Significant
improvement or worsening in microperimetry was defined
as a change in sensitivity of $1 dB, a change in stability of
fixation, or both.
Measurements of HEX by a
semiautomated algorithm
We used the semiautomated algorithm for HEX measurements;
this algorithm uses a 2-pronged methodology, involved per-
forming top-hat filtering, second-order statistical filtering,
and thresholding of the color fundus images.
In brief, a 2-pronged approach was adopted to detect both
bright and weak/faint HEX. In Step 1, to detect bright HEX,
top-hat17 filtering was first used on the gray scale image of
the color fundus photograph using a structuring element
(disk, where the radius of the disk is considered to be ¼ the
width of the image) to make background illumination more
uniform. Subsequently, adaptive histogram equalization17
was performed to further enhance the exudates from the back-
ground. Then, the enhanced image was binarized using an
empirically determined threshold (0.37) for segmenting the
exudates from the background, in which the brighter pixels
indicate the exudates. However, in addition to the exudates,
some outliers also were obtained due to reflections from the
optic disk and retinal vessels in the nerve fiber layer.
Next, in Step 2, we proceed to detect the weaker exudates
that may not have been detected in Step 1. Here, only the
green plane of the color fundus image is considered because
weak exudates are better contrasted in the green plane than in
the grayscale image or the red and blue planes. Then, similar
operations that were used in Step 1 were subsequently per-
formed but with different thresholds. Specifically, the radius
of the structuring element for performing top-hat filtering is
decreased to one quarter of the width of the image, and the
threshold for binarization is empirically determined as 0.25
for images obtained after the respective operations. Step 2
also resulted in a few outliers due to the same reasons men-
tioned earlier in Step 1.
Now, the results of Step 1 and Step 2 are combined, and
the outliers are removed manually using a rectangular selec-
tion box. Finally, the total area of the detected HEX is mea-
sured to facilitate monitoring of the treatment response.
Color fundus photographs were analyzed using this algo-
rithm by a single observer. Intraobserver reproducibility was
evaluated using the first 15 images and was found to correlate
well, with an intraclass correlation coefficient of 0.94.
Intravitreal injection of the
dexamethasone implant
All individuals who met the study criteria underwent intravit-
real injection of the dexamethasone (0.7 mg) implant into the
eye following all aseptic precautions in a sterile environment.
After topical anesthesia and Betadine® (Mhs Pharmaceuti-
cals Private Limited, Hyderabad, India) 10% preparation
of the eye, the implant was injected in the inferotemporal
quadrant. When 2 eyes of the same individual fit the study
criteria, the 2 eyes were injected at an interval of 3 days.
No postinjection prophylaxis or patching was recommended.
Injections were performed at baseline and at Month 4.
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Study visits
All patients were examined at baseline and at Days 60,
120, 180, and 240. Comprehensive examination, BCVA,
LCVA, fundus photography, SD-OCT, and microperimetry
were done at all visits. FFA was performed at baseline,
Day 120, and Day 240. All individuals were advised to get
the IOP measured locally at 2 weeks after the intravitreal
dexamethasone implant injection, to rule out any inadvertent
steroid-related rise in IOP.
Outcome measures
Primary outcome measure
The primary outcome of interest was the change in total area
of HEX at the macula (in mm2), measured by a semiauto-
mated algorithm.
Secondary outcome measures
The secondary outcome measures were changes in visual
acuity, LCVA, RS on macular microperimetry, and central
subfield thickness on SD-OCT.
Statistical analysis
Statistical analysis was performed using SPSS software
(version 16.0; SPSS, Chicago, IL, USA), with special
emphasis on the aforementioned information. Wilcoxon
signed-rank test was used for statistical analysis of various
outcome measures. The follow-up rate was 87%, and there-
fore, last observation carried forward (LOCF) analysis was
performed. Values of p,0.05 were considered statistically
significant.
Results
Fifteen eyes of 11 patients, 6 males and 5 females, were
included in the study. Mean age was 54.4±8.1 years.
All patients had type 2 diabetes mellitus. Three patients
were on antihypertensive medications, and 2 patients were
on lipid-lowering medications. None of the patients were
smokers. All eyes, but 1, were phakic. Phakic eyes had
grade I nuclear sclerosis in 5 eyes and grade 2 in 3 eyes; the
remaining 6 eyes had clear crystalline lens. A representative
case of the phakic eye is shown in Figure 1.
Anatomical outcome
The total area of HEX at the macula was 1.5 mm2 (±1.46 mm2)
at presentation. This reduced to 0.89 mm2 (±1.062 mm2) at
the final visit. This was a clinically significant decrease over
the short duration even though statistically insignificant
(p=0.185).
The CMT of the patients in our study improved signifi-
cantly (p=0.03) from a baseline of 488.67 μm (±240.66 μm)
to 326.93 μm (±135.84 μm).
Visual outcome
Mean BCVA at presentation was 50.93 (±16.65) ETDRS
letters. At the 8-month follow-up, BCVA remained stable
at 50.6 (±18.95) ETDRS letters; this was statistically not
significant ( p=0.95). The mean LCVA at presentation was
1.15 (±0.39) (approximate Snellen’s equivalent of 20/300),
which improved to 0.97 (±0.43) (approximate Snellen’s
equivalent of 20/200) at the final visit; this was statistically
not significant ( p=0.31).
Functional outcome
The average threshold microperimetry values improved from
6.99 dB (±8.897 dB) at presentation to 11.91 dB (±7.64 dB)
at final follow-up. This showed a trend toward an improve-
ment in the macular function over time despite the results
appearing statistically insignificant ( p=0.28).
Cataract progression
Among the phakic eyes, 1 eye with grade I nuclear sclerosis
at baseline had posterior subcapsular cataract and 4 eyes with
clear crystalline lens at baseline had early nuclear sclerosis
at the final visit.
Change in IOP
Mean IOP at baseline was 13.2±2.59 mmHg, which remained
stable till the final visit at 14.46±3.46 mmHg (p=0.26). One
patient had an increase in IOP (26 mmHg) at Month 2,
which was controlled using antiglaucoma medication till
the final visit.
Diabetic retinopathy grading
At baseline, 14 eyes had moderate nonproliferative diabetic
retinopathy (NPDR) and 1 eye had stable lasered prolifera-
tive diabetic retinopathy (PDR; lasering was done 9 months
before the enrollment). None of the eyes had change in their
diabetic retinopathy status till the final visit.
Table 1 shows a short summary of the results.
Discussion
Our study showed a trend toward decrease in total surface
area of HEX at the macula, along with an increase in RS,
following dexamethasone implantation. Though these results
were not significant, they bode well for long-term follow-up
of patients on these implants. A trend toward decreasing HEX
in DME has been described with both anti-VEGF injections10
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Hard exudates and dexamethasone implant
Figure 1 Representative case of phakic eye.
Notes: (A) A 56-year-old male presented with moderate NPDR and center-involving macular edema with plenty of HEX. He underwent 2 intravitreal dexamethasone
implantations at baseline and at Month 4. (B) His visual acuity improved from 20/200 to 20/100 at Month 8, with reduction in HEX. Quantitative analysis of HEX showed a
reduction from (C) 1.9 mm2 to (D) 1.75 mm2. Spectral domain optical coherence tomography showed a reduction in subfoveal HEX (arrow) and reduction in central macular
thickness as can be seen at (E) baseline and (F) Month 8. Retinal sensitivity map shows improvement from (G) baseline to (H) Month 8.
Abbreviations: HEX, hard exudates; NPDR, nonproliferative diabetic retinopathy.
Table 1 Observations of the MERIT study at baseline and nal follow-up
Characteristics At baseline –
mean (±SD)
At 8 months –
mean (±SD)
p-value
BCVA in ETDRS letters 50.93 (±16.654) 50.6 (±18.95) 0.959
Contrast sensitivity (logMAR) 1.15 (±0.39) 0.97 (±0.43) 0.31
Central macular thickness (μm) 488.67 (±240.66) 326.93 (±135.84) 0.03
Hard exudates area (mm2)1.525 (±1.46) 0.89 (±1.06) 0.19
Average threshold retinal sensitivity (dB) 6.99 (±8.896) 11.91 (±7.64) 0.29
Abbreviations: BCVA, best-corrected visual acuity; ETDRS, Early Treatment Diabetic Retinopathy Study; logMAR, logarithm of the minimum angle of resolution;
MERIT, macular edema resolution assessment with implantable dexamethasone in diabetic retinopathy.
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Chhablani et al
and steroids;11,13,18 however, in these cited studies, the quanti-
fication of HEX and assessment of RS as functional outcome
were not carried out.
In our study, we noted a significant decrease in the CMT
despite the short duration of follow-up; this demonstrates the
efficacy of the dexamethasone implant in treating DME, as
has been documented earlier.13,18 However, we did not notice
a significant change in the BCVA, LCVA, and RS. This
could be explained by the neuronal and structural damages
secondary to the chronic nature of the DME, cataract progres-
sion, and presence of subfoveal HEX.
Corticosteroids reduce the inflammation and lead to
recovery of blood–retina barrier, in addition to their anti-
VEGF property. Triamcinolone has been shown to cause
resorption of HEX in various small case series in eyes with
DME.3,5,6 Dexamethasone increases the vascular resistance
and reduces permeability, which contributes to faster resolu-
tion of HEX.
Khairallah et al6 report resolution of HEX after single
intravitreal triamcinolone injection at a mean of 8 months of
follow-up. Similarly, Avci and Kaderli3 and Ciardella et al5
also report resolution of HEX in chronic DME with improve-
ment in visual acuity. These studies have reported an increase
in IOP in 25%–40% of eyes, which required antiglaucoma
medications. None of these studies have evaluated functional
outcomes. Moreover, dexamethasone implants have less
frequent and transient episodes of increased IOP, which can
be managed successfully with topical medications.19
Contrast sensitivity and RS are considered to be comple-
mentary tools in functional vision evaluation in DME.20
Vujosevic et al21 have previously found macular microperim-
etry to be an excellent additional tool to add to BCVA and
CMT as a factor explaining visual function in patients with
DME; they had also demonstrated a significant change in
microperimetry results in patients with normalizing macular
thickness in center-involving DME. Mastropasqua et al22 have
found that RS, as measured by microperimetry, improved
after dexamethasone implantation as early as 1–4 months
after the injection. Similar findings have also been noted ear-
lier by Querques et al.23 Our study demonstrated an improve-
ment in functional outcome (RS) following dexamethasone
implantation, even in the presence of subfoveal exudates.
Limitations of our study include the small sample size
and lack of a control group. We did not evaluate SD-OCT
structural changes with various outcome measures. We are
unable to comment on comparative outcomes with anti-
VEGF therapy. We did not evaluate the distance of HEX
from the fovea, which could be an important parameter to
assess the foveal migration during follow-up.
The strength of this study was that we evaluated HEX
resolution as the primary outcome measure in a prospective
manner, along with the impact on the anatomical, visual,
and functional changes. We performed a quantitative assess-
ment of HEX using a validated semiautomated algorithm,
not subjectively as done in earlier studies. Our objective
approach could be used in the consideration of HEX as one
of the outcome measures in clinical trials on DME evaluating
various treatment modalities.
Conclusion
Our pilot study demonstrated reduction of total HEX and
improvement in RS, along with a reduction in CMT. Poor
visual outcomes were related to the persistence of subfo-
veal HEX; therefore, early consideration of dexamethasone
implantation in eyes with HEX close to the fovea may be
beneficial. Long-term studies with a larger sample size with
a control group are warranted to establish management
protocols for DME with significant subfoveal HEX.
Acknowledgment
The manuscript has not been presented at any meetings and
no funding was provided for the study.
Disclosure
The authors report no conflicts of interest in this work.
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