management of dme in eyes with pdr -...
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The Diabetic Retinopathy Clinical
Research Network
Management of DME in Eyes with
PDR
1
What Has Been Learned?
Diabetic Retinopathy Treatment
Protocol F: Results suggest that clinically meaningful
differences are unlikely in OCT thickness or visual
acuity following application of PRP in 1 sitting compared
with 4 sittings in absence of DME. These results suggest
PRP costs to some patients in terms of travel and lost
productivity as well as to eye care providers could be
reduced. Diabetic Retinopathy Clinical Research Network. Observational study of the
development of diabetic macular edema following panretinal (scatter)
photocoagulation given in 1 or 4 sittings. Arch Ophthalmol.2009
Feb;127(2):132-40
2
Diabetic Retinopathy Clinical Research Network. Randomized Trial Evaluating Short-Term
Effects of Intravitreal Ranibizumab or Triamcinolone Acetonide on Macular Edema Following
Focal/Grid Laser for Diabetic Macular Edema in Eyes Also Receiving Panretinal
Photocoagulation. Retina. 2011 June;31(6):1009-27
Randomized Trial Evaluating Short-Term Effects of
Intravitreal Ranibizumab or Triamcinolone Acetonide
on Macular Edema Following Focal/Grid Laser for
Diabetic Macular Edema in Eyes Also Receiving
Panretinal Photocoagulation. (Protocol J)
3
*Adjusted for baseline visual acuity, number of planned PRP sittings, and correlation between 2 study eyes.
** Missing (or un-gradeable) data as follows for the sham+focal/grid/PRP laser group, ranibizumab+focal/grid/PRP laser group,
and triamcinolone+focal/grid/PRP laser groups, respectively: 3, 3, 2 † Adjusted for baseline OCT retinal thickness and visual acuity, number of planned PRP sittings, and correlation between 2
study eyes. Confidence intervals are adjusted for multiple comparisons.
4
Results
Mean Change from baseline to 14 Weeks
Sham+
Focal/Grid/P
RP Laser
N = 123
Ranibizumab+
Focal/Grid/PR
P Laser
N = 113
Triamcinolo
ne+
Focal/Grid/P
RP Laser
N = 109
Visual Acuity -4 +1 +2
Difference in mean change
from Sham
+Focal/Grid/PRP Laser [P
Value]*
+5.6
[P < 0.001]
+6.7
[P < 0.001]
OCT central subfield
thickening (µm)** -5 -39 -92
Difference in mean change
from Sham+
Focal/Grid/PRP Laser
[P Value] †
-35
[P = 0.007]
-100
[P < 0.001]
000 444 141414 343434 565656
Me
an
Ch
an
ge
in
Vis
ua
l A
cu
ity
fro
m B
as
elin
e (
lett
er
sc
ore
)
-5
-4
-3
-2
-1
0
1
2
3
4
5
Sham+Focal/Grid/PRP Laser
Ranibizumab+Focal/Grid/PRP Laser
Triamcinolone+Focal/Grid/PRP Laser
Mean Change in Visual Acuity* from
Baseline
5
Safety Phase (DME treatment at investigator discretion)
Randomized Phase (DME treatment according to protocol)
* Values that were ±30 letters were assigned a value of 30
000 444 141414 343434 565656
Mean
Ch
an
ge in
OC
T C
en
tral S
ub
field
Th
ickn
ess f
rom
Baselin
e (
mic
ron
s)
-120
-100
-80
-60
-40
-20
0
20
40
60
80
100
120 Sham+Focal/Grid/PRP Laser
Ranibizumab+Focal/Grid/PRP Laser
Triamcinolone+Focal/Grid/PRP Laser
Mean Change in Retinal Thickness
from Baseline
6 Randomized Phase
(DME treatment according to protocol)
Safety Phase (DME discretion)
Safety Phase (DME treatment at investigator discretion)
Summary Randomized Phase
14 week primary outcome visit: • On average, both ranibizumab and triamcinolone statistically
significantly improve visual acuity and retinal thickness compared to
sham injection in eyes with central DME receiving focal/grid laser and
requiring prompt PRP
• Focal/grid given with PRP does not, on average, reduce edema in short-
term (in contrast to focal/grid in absence of PRP which does reduce
edema)
Safety Phase
14 week to 56 week visits:
• Differences in visual acuity and retinal thickness outcomes above no
longer identified
7
Conclusion
The addition of 1 intravitreal triamcinolone or
2 ranibizumab injections in eyes receiving
focal/grid laser for DME and PRP is associated
with better visual acuity and decreased
macular edema by 14 weeks, but these effects
are not maintained by 56 weeks in absence of
continued injections for persistent or
recurrent DME.
8
Coexisting PDR and DME
49 yo BM NIDDM x 20 yrs VA 20/50 RE 20/200 LE
9
Coexisting PDR and DME
Irregular FAZ, temporal
capillary non-perfusion, NVE
Capillary nonperfusion
adjacent to FAZ; fluorescein in
cystoid spaces
10
No DME RE
11
But substantial DME LE
12
Coexisting PDR and DME LE
13
NVE nasally
Capillary nonperfusion
adjacent to FAZ; fluorescein in
cystoid spaces
Coexisting PDR and DME
14
Treatment OS
One week later VA 20/25
RE
PRP OD 2331 spots
Pascal laser (complete)
200 microns, 20 msec,
343 mW, Mainster 165
lens
No anti-VEGF or
steroids given
Treatment OD
One week later VA
20/200 LE and RZB 0.3
mg IVT given
2 weeks after RZB, PRP
OS 1683 spots Pascal
laser (incomplete), 200
microns, 20 msec, 275
mW, Mainster 165 lens
2 weeks post PRP RE, no new DME,
VA 20/25
15
2 weeks post ranibizumab LE, DME
persists but better, VA 20/200, PRP done
16
4 weeks post RZB, 2 weeks post PRP LE,
DME reduced, VA 20/200
17
Conclusions and Opinions
Management of coexisting DME and PDR is challenging but pharmacologic
treatment of the DME component reduces the risk of exacerbation of the DME
post-PRP in the short term
In eyes without DME that receive PRP for PDR or severe NPDR, the risk of
developing DME post-PRP is low, even if the PRP is completed in one sitting
Extrapolating current knowledge of anti-VEGF treatment of center involved
DME from multiple trials, treatment of DME with anti-VEGF therapy prior to
PRP should be continued post laser until the DME is stabilized or resolved to
achieve the best visual outcomes
Additionally, focal/grid laser plus anti-VEGF injection prior to PRP may not be
necessary since no additional benefit of laser has been found when treating
center involved DME alone
Protocol S will give additional data on the effect of ranibizumab on DME in
the setting of PDR treated with PRP
18
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