Transcript The Diabetic Retinopathy Clinical Research Network

The Diabetic Retinopathy Clinical
Research Network
What is the Role of Laser In
Treating Diabetic Macular Edema
in the Era of Anti-VEGF Therapy?
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Financial Disclosures
None
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7-6-11
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12-7-11
After 3 Anti-VEGF injections
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2-29-12
After 6 Anti-VEGF injections
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What should be done next?
Is Laser the next step?
Does it help?
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Response to Laser
in the ETDRS
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Mean Visual Change
from Baseline
ETDRS Data*:
Change in VA from Baseline
0
-2
N = 540
-4
N = 518
N = 1071
-6
-8
N = 1029
Focal/Grid Laser
Observation Only
-10
N = 495
N = 972
-12
4
8
12
16
20
Months
*Of eyes with CI-DME at baseline
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32
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 Anti-VEGF therapy is now the gold standard for
treating diabetic macular edema in eyes with
impaired vision. Focal laser is now used for eyes
not responding well to Anti-VEGF or eyes where
Anti-VEGF is contraindicated. Some doctors use it
as the primary treatment in eyes with very focal
disease such as a circinate ring.
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DRCR.net Protocol I Data
(Ranibizumab+prompt laser
& Ranibizumab+deferred
laser groups)
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Visual Acuity
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Mean Change in Visual Acuity*
at Follow-up Visits
Change in Visual Acuity from
Baseline (Letter Score)
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10
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Ranibizumab + Prompt Laser
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Ranibizumab + Deferred
Laser
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N = 338 (52 weeks)
N = 317 (104 weeks)
N = 291 (156 weeks)
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0
0
4
8 12 16 20 24 28 32 Visit
36 Week
40 44 48 52 68 84 104120136156
*Truncated to ± 30 letters
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Change in Visual Acuity*
Change in Visual Acuity
(letters)**
2-years (Estimated
Means)
3- Years (Estimated
Means)
Ranibizumab
+
Prompt
Laser
N = 144
+7.2
+6.8
Ranibizumab
+
Deferred
Laser
N = 147
Estimated
Difference (B vs. C)
(95% CI)
[P-Value]
+9.0
-1.8 (-3.6 to
+0.1)
[P = 0.06]
+9.7
-2.9 (-5.4 to 0.4)
[P = 0.02]
*Visits occurring between 980 and 1204 days from randomization were included as 3 year visits 15
**truncated to ± 30 letters, based on longitudinal analyses adjusting for baseline VA
Retinal Thickening
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Mean Change in OCT Central
Subfield Thickness from
Baseline (Microns)
Mean Change in CSF Thickening
at Follow-up Visits
0
-20
-40
-60
-80
-100
-120
-140
-160
-180
-200
Ranibizumab +
Prompt Laser
N = 334 (52 weeks)
N = 305 (104 weeks)
N = 259 (156 weeks)
1 2 3 4 5 6 7 8 9Visit
10 Week
11 12 13 14 15 16 17 18 19 20
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Change in Retinal Thickening at 3 Years*
Change in OCT CSF
Median change from baseline
(µm)
Mean change from baseline (µm)
Thickness <250 µm with at least
a 25 µm decrease from baseline
Ranibizumab
+ Prompt Laser
N = 136
Ranibizumab
+ Deferred Laser
N = 132
-142
-155
-152
-174
61%
63%
*Visits occurring between 980 and 1204 days from randomization were included as 3 year visits 18
Focal/Grid Laser Prior to 3 Years*
Ranibizumab
+ Prompt Laser
N = 144
Ranibizumab
+ Deferred Laser
N = 147
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10
3
0
100%
46%
Maximal possible number of focal/grid
laser treatments prior to 3-year visit
Median number of focal/grid laser
treatments from baseline to (prior to) 3year visit
% of eyes that received focal/grid laser
treatments from baseline to (prior to) 3year visit
* Only eyes that completed 3-year visit
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DRCR.net New Protocol
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Study Objectives
To compare the efficacy and safety of
1. Anti-VEGF with no laser
2. Anti-VEGF with deferred laser
in eyes with DME.
Efficacy will be assessed by
change in visual acuity at 1 year.
The study will be 2 years in
duration.
Protocol T Treatment Algorithm
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