Challenging cases in diabetic retinopathy - DME protocol

Challenging Cases in Diabetic
Retinopathy

Case 1
• A59-year-old man with type 2 diabetes.
• Hx: severe NPDR & ME involving fovea in BE
• VA:RE: 6/48
LE: and 6/9.5

Fundus & OCT
Edema of central macula in BE

Treatment
• RE: focal/grid laser followed by 6 monthly
Avastin*
• LE: 11 monthly Avastin*
• 1.5 later. VA: RE: 6/6 & LE: 6.7.5
* Based (DRCR.net) study which showed anti-VEGF superiority to focal/grid laser for center-involved DME.

Follow up
• 1.5 later
• VA:RE: 6/6
LE: 6.7.5
• He continued to have persistent fovea-
involving edema in the RE & LE and
juxtafoveal edema in the LE
• Given his good visual acuity additional
treatment for his DME was withheld.

Follow up
• 1 year later.
• VA:RE 6/6
LE: 6/4.8

OCT: persistent fovea-involving edema in
RE & juxtafoveal edema in LE

Which of the following might be the
best next step for the patient's RE?
• Intravitreous injections
• Continue observation
• Focal/grid laser

Explanation
• ETDRS: photocoagulation was better than observation
for eyes with CSME
• This is NOT necessarily applicable to eyes that have had
anti-VEGF treatment and achieved stable vision with
visual acuity ≥6/7.5 despite persistent DME.
• DRCR.net treatment regimen included observation
when vision stability was reached despite persistent
edema
• It is reasonable to continue observation of eyes with
DME and visual acuity ≥6/7.5 and only resume anti-
VEGF treatments when vision deteriorates

Which treatment is generally superior
for DME involving the center of the
macula in eyes with vision impairment?
• Intravitreous triamcinolone injection with prompt
focal/grid laser to DME
• Intravitreous Lucentis injection with deferred
focal/grid laser to DME for at least 6 months
• Intravitreal Lucentis injection with prompt focal/grid
laser to DME

Explanation
• Randomized clinical trials: have shown that Lucentis with
deferred or prompt focal/grid laser was superior to
focal/grid laser alone for the treatment of DME involving
the center of the macula
• Five-year follow-up data; focal/grid treatment at the start
of Lucentis was no better than deferring it for 6 months
• Focal/grid laser treatment at the start of intravitreous anti-
VEGF therapy is not recommended.
• Intravitreous triamcinolone injection with laser did not
result in a significantly greater increase in visual acuity
compared to laser alone and was associated with an
increased risk of cataract development and elevated IOP

Follow up
• 2 years after his last intravitreal anti-VEGF
• Patient presented with:
• VA:RE: 6/12
LE: 6/15

Treatment
• Intravitreous anti-VEGF treatment is resumed
in both eyes.

Which of the following is most
appropriate anti-VEGF agent to use in
LE to maximize vision improvement?
• Aflibercept (Eylea)
• Ranibizumab (Lucentis)
• Bevacizumab (Avastin)
• There is no difference between the anti-VEGF
agents listed

Explanation
• DRCR.net compared the use of aflibercept,
ranibizumab, and bevacizumab in patients with DME
involving the central macula.
• When the initial visual acuity loss was mild (6/9.5-
6/12) there was NO difference in mean improvement
in eyes treated with aflibercept, ranibizumab, or
bevacizumab.
• When initial visual acuity was ≤6/15 mean
improvement in visual acuity was significantly
greater in eyes that were treated with aflibercept
• The trial included eyes that had not received any anti-VEGF treatment for more than a year

Which of the following should NOT be included
in a laser treatment regimen for persistent DME
despite anti-VEGF injections?
• Focal (direct) laser to microaneurysms within thickened areas
of the macula
• Grid laser to edema without microaneurysms, 500-3000 µm
superiorly, inferiorly, and nasally from center
• Grid laser to areas of capillary non-perfusion within macula
that are not thickened
• Grid laser to edema without microaneurysms, 500-35000 µm
temporally from center

Explanation
• DRCR.net: Focal and grid treatment are
applied when laser for DME is considered.
• Focal laser should be applied to
microaneurysms in areas of retinal thickening.
• Grid laser should be applied to areas with
edema not associated with microaneurysms
and areas of capillary non-perfusion within
areas of edema judged to be contributing to
the edema.

Focal/grid treatment protocol
Edema threatening or involving the center of the macula,
including any of the following:
• Optical coherence tomography central subfield thickness ≥2
standard deviations from normal (eg, ≥250 µm on OCT)
• Edema within 500 µm of the center of the macula
• Edema associated with lipid within 500 µm of the center of
the macula or ≥1 disc area within 1 disc area of the center
of the macula
• Complete laser (direct treatment to all microaneurysms
within the areas of macular edema and grid treatment
already applied to all other areas of macular edema) has
not been applied
• 13 weeks or longer since focal/grid laser was administered

Focal/grid technique protocol
• Direct laser to all microaneurysms in areas of retinal thickening
between 500 and 3000 µm from the center of the macula
• Direct laser to all microaneurysms in areas of retinal thickening
between 300 and 500 µm of center of macula if center-involved
edema persists after an initial focal/grid laser session, but generally
not if visual acuity is ≥20/40
• 50- to 60-µm spot size
• 0.05- to 0.1-second duration
• Green to yellow wavelengths
• End point of laser burn: change color of microaneurysm or at least a
mild gray-white burn evident beneath microaneurysm
• Grid laser is applied to all areas with edema not associated with
microaneurysms between 500 and 3000 µm superiorly, nasally, and
inferiorly from the center of the macula and between 500 and 3500
µm temporally from the center of the macula, separating laser
burns at least 2 burn widths apart, again with a 50- to 60-µm spot
size and 0.05- to 0.1-second duration

Follow up
• After receiving intravitreous anti-VEGF
injections in both eyes at the last visit, the
patient continued to follow up with monthly
visits.
• At the visit following his first injection the
patient showed no improvement in visual
acuity.

Which of the following is the best
course of action?
• Continue up to 6 monthly anti-VEGF injections if there
has been no success and deferring after 2 consecutive
monthly injections with no improvement
• Withhold after the next anti-VEGF injection if either
visual acuity or OCT central subfield thickness worsens
• Withhold after the first injection since there has been
no improvement on either OCT central subfield
thickness or visual acuity
• Withhold after 3 consecutive monthly injections if
there has been no improvement in either OCT central
subfield thickness or visual acuity

Explanation
• DRCR.net: anti-VEGF agents were injected into study eyes at
baseline and every month for the first 6 months, unless there was
"success" (visual acuity ≥6/6 with a central subfield thickness below
the eligibility threshold for DME and there was no improvement or
worsening in response to the past 2 injections).
• Starting at the 6-month visit irrespective of visual acuity and central
subfield thickness, an injection was withheld if there was no
improvement or worsening after 2 consecutive injections.
• Treatment was resumed if visual acuity or central subfield thickness
worsened.
• Following this treatment protocol, good visual acuity outcomes
were achieved using all 3 anti-VEGF agents, on eyes with a baseline
visual acuity ≤6/15
It is advisable to consider this treatment protocol when treating DME
using anti-VEGF agents.

Conclusion
• After 6 consecutive monthly injections of
intravitreous aflibercept in both eyes, the patient
had stable visual acuity and OCT central subfield
thickness for the last 2 injections.
• Further anti-VEGF treatments are withheld.
• The patient now has a visual acuity of 6/6 in both
eyes.
• He continued to follow up regularly to monitor
for any worsening of visual acuity, DME, or DR
that may require additional treatment.

Case 2
• An 83-year-old black man with type 2 diabetes.
• Hx: RE: CRAO since 5 years
LE: PDR with DME
• VA: RE: 6/60
LE: 6/12
• LE treatment received:
– PRP & focal/grid laser, followed by 4 monthly intravitreous injections
of Avastin
• 6 months after initial presentation:
– VA: LE: 6/9.5
– NO macular edema

Fundus & OCT
Resolution of ME in his left eye
NO Additional treatment for
DME in his left eye

New presentation
Left Eye
• VA: LE:6/19
• Mild nuclear and cortical cataract
• Fundus: PRP lesions outside the posterior pole
Lipid and increased edema in the center of
the macula as documented on OCT image

Which of the following is the best next
step for treating this patient's left eye?
• Proceed with cataract surgery
• Re-initiate intravitreous anti-VEGF injections
• Begin intravitreous corticosteroid injections
• Continue observation

Explanation
• DRCR.net Protocol: treatment for center-involved DME with:
– intravitreous anti-VEGF therapy (Lucentis) plus
– deferred (>24 weeks) or prompt focal/grid laser
Provides VA outcomes at 1 and 2 years are superior to prompt
focal/ grid laser alone or intravitreous triamcinolone with prompt
focal/ grid laser
• DRCR.net Protocol: In eyes that had not received anti-VEGF therapy
for more than 1 year, reinitiating anti-VEGF therapy with either
aflibercept, bevacizumab, or ranibizumab was shown to generally
improve visual acuity
• DRCR.net Protocol: Treatment for DME should also begin prior to
cataract surgery. DRCR.net showed that eyes with non-central DME
immediately prior to cataract surgery are at higher risk of
developing central-involved ME 16 weeks after the cataract
extraction than those with no history of DME treatment or DME

Which treatment is superior for CSME from
DR in eyes with VA of 6/7.5 or better?
• Intravitreous anti-VEGF injection
• Intravitreous corticosteroid injection
• Observation

Explanation
• Focal/grid photocoagulation of eyes with DME reduced
the risk of moderate visual loss by approximately 50%
(from 24% to 12%) 3 years after initiation of treatment
• There is no current evidence demonstrating the benefit
of intravitreous anti-VEGF or corticosteroid injections
in DME patients with visual acuity ≥6/7.5
• When visual acuity is ≥6/7.5 the risk of
endophthalmitis poses a potentially greater relative
risk to patients than when it is more impaired

Treatment
• The patient received 4 consecutive monthly
intravitreous Lucentis injections over 3
months
• During this time:
– LE: VA: improved to 6/15
– The central retinal subfield thickness on OCT
image also gradually improved

step for the LE?
• Withhold anti-VEGF injection and proceed
with cataract surgery
• Continue intravitreous ranibizumab injection
• Switch to intravitreous aflibercept injection
• Begin intravitreous corticosteroid injection

Explanation
• DRCR.net: anti-VEGF agents were injected into study eyes at baseline and
every 4 weeks for the first 6 months, unless visual acuity was ≥6/6 with a
central subfield thickness below the eligibility threshold for DME and
there was no improvement or worsening in response to the past 2
injections.
• Improvement:
– Increase in the VA letter score ≥5 (approximately 1 Snellen line) or
– Decrease in the central subfield thickness ≤10%
• Worsening:
– Decrease in the visual-acuity letter score ≥5 or
– Increase in the central subfield thickness ≥10%.
• Following this treatment protocol, good visual acuity outcomes were
achieved using all 3 anti-VEGF agents, when initial visual acuity was ≤6/15
at 1 year after treatment initiation
It is advisable to consider this treatment protocol when treating DME using
anti-VEGF agents

In addition to DME and surgical
complications, which of the following
is a risk factor for ME after cataract
surgery?
• Gender
• Glaucoma
• Uveitis
• Aging

Explanation
• Pseudophakic CME, known as Irvine-Gass
syndrome, is one of the most common causes
of visual loss after cataract surgery.
• Many risk factors have been reported to cause
pseudophakic CME including:
– Surgical complication
– DME
– Uveitis

Treatment
• The patient received 12 consecutive monthly
intravitreous Lucentis injections since the first
presentation, during which time:
• LE: VA improved to 6/12
He has increasing PSCC
He has gradually improved central retinal
subfield thickness on OCT

Current visit
left eye VA central retinal subfield thickness on
OCT image are not improved compared with the
previous 2 consecutive monthly visits

step for the LE?
• Withhold anti-VEGF injection until worsening
on OCT and proceed with cataract surgery
• Continue intravitreous ranibizumab injection
• Switch to intravitreous aflibercept injection
• Begin intravitreous corticosteroid injection

Explanation
• DRCR.net: anti-VEGF agents were injected into study eyes at
baseline and every 4 weeks. Starting at the 6-month visit, an
injection was withheld if there was no improvement or
worsening after 2 consecutive injections, but treatment was
resumed if visual acuity or central subfield thickness
worsened.
• Improvement:
– Increase in the VA letter score ≥5 (approximately 1 Snellen line) or
– Decrease in the central subfield thickness ≤10%
• Worsening:
– Decrease in the visual-acuity letter score ≥5 or
– Increase in the central subfield thickness ≥10%.
• It is time to withhold treatment and proceed with cataract
surgery.

Treatment
• Intravitreous anti-VEGF injections are withheld and cataract
surgery is performed in the patient's LE
• He returns for follow-up 2 months after cataract surgery.
• LE: VA: 6/12
• Fundus showed re-accumulation of ME
• It is decided to resume intravitreous Lucentis injections in
his left eye to try to reduce his risk of further vision loss.
• Later, the patient had stable VA and OCT central subfield
thickness shows no abnormal thickening.
• Once stability in visual acuity and OCT thickness following 2
consecutive injections is attained anti-VEGF treatment is
withheld

A 60-year-old man with type 2 DM
presents with RE; VA 6/15 & center-
involved DME. He has not received any
treatment to date.
Which of the following is the best
option for treating this patient?
• Focal/grid laser therapy
• Intravitreous anti-VEGF therapy
• Intravitreous corticosteroid therapy
• Observation

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