1. The Diabetic Retinopathy Clinical Research Network
A Randomized Trial Comparing
Intravitreal Triamcinolone Acetonide
to Focal/Grid Photocoagulation
for Diabetic Macular Edema
Sponsored by the National Eye Institute,
National Institutes of Health, U.S. Department of Health and Human Services

2. Background

3. Background – Diabetic Macular Edema
Common cause of vision loss
Focal/grid laser reduces chance of moderate vision loss
Search for better treatments includes intravitreal injection of triamcinolone (IVT)

4. Intravitreal Triamcinolone (IVT) for DME
: potential benefit first reported1,2
2002: 52% of retina specialists had used IVT for DME3
Short term improvement in visual acuity
Rapid decrease in retinal thickening on OCT
1- Jonas JB, et al. Am J Ophthalmol 2001;132:425-7
2- Martidis A, et al. Ophthalmology 2002;109:920-7
3- American Society of Retina Specialists Preferences and Trends Survey 2002

5. Rationale for a Randomized Study
Short term data suggests benefit
Known side-effects
Risk of non-infectious endophthalmitis
Post-injection ocular inflammation reported with off-label intravitreal Kenalog (Bristol-Myers Squibb, Princeton, NJ)
No long term safety or efficacy data
No randomized comparison with standard care (focal/grid photocoagulation)

6. Primary Study Objective
To compare the efficacy and safety of preservative-free IVT (1 mg or 4 mg) with focal/grid laser

7. Study Design Multicenter, randomized clinical trial
Major Eligibility Criteria Assessed:
>18 years old
Type 1 or type 2 diabetes
Center-involved DME (with OCT CSF >250 µm)
VA letter score 73 to 24 (20/40 to 20/320)
Eligible eyes randomized
Subjects with 2 study eyes assigned alternative treatment in 2nd eye
Focal/Grid
Laser
1 mg
IVT
4 mg
IVT

8. Follow-up and Treatment Schedule
Randomized treatment at Month 0
Focal/Grid
Laser
1 mg
IVT
4 mg
IVT
Re-treatment (within 4 wks) unless any of the following:
Treatment successful
Substantial improvement in macular edema
Adverse events or maximal treatment
Further treatment appears futile
Month 4 .
Follow-up visits
every 4 months*
Re-treatment assessed and protocol enforced at
every 4-month interval visit .
Month 36
* Additional safety visits 4 days and 4 weeks after injections

9. Efficacy Outcomes Primary outcome assessment at 2 years
Primary measure: visual acuity (VA)
Scientific objective: mean change in VA
Regulatory objective for FDA: proportion with decrease in VA letter score >15
Secondary measure: Retinal thickness on OCT

10. Safety Outcomes Injection-related events Steroid-related toxicities
Infectious or inflammatory endophthalmitis
Retinal detachment
Steroid-related toxicities
Cataract
IOP related effects

11. Focal/Grid Photocoagulation Treatment
Modified-ETDRS technique:
Burn Size
50 microns
Burn Duration
seconds
Wavelength
Green to yellow
Intensity
Barely visible (light gray)
Grid Treatment
Cover areas of diffuse retinal thickening or nonperfusion 2 burn widths apart*
Direct treatment of microaneurysms
All microaneurysms are treated directly, but only in areas of retinal thickening
Placement of laser treatment
Retina thickening microns from center of fovea
*Cover areas of retinal thickening not judged to be due to microaneurysms 2 burn widths apart. If a fluorescein angiogram is obtained, cover areas of retinal thickening 2 burn widths apart within areas on angiography of diffuse leakage from retinal telangiectasis and consider covering areas of non-perfusion.

12. IVT Treatment Aseptic technique
Antibiotics on day of procedure (not required on days prior to injection)
5% povidone iodine
Lid speculum
Injection of 0.05 cc volume with 27 or 30 gauge needle

13. 2 and 3 Year Results

14. Study Enrollment and Completion
840 eyes (693 subjects) enrolled at 88 clinical sites
Treatment Groups
Laser: N = 330
1 mg: N = 256
4 mg: N = 254
2-year visit completion rate
83% including deaths
88% excluding deaths

15. Completion of 3 Year Visit
Trial was discontinued following completion of all 2 year visits
Excluding deaths, 44% had potential* to complete, and of those 82% completed
7% deaths
48% non-completer w/out potential*
9% non-completer w/potential*
36% completed
Similar rates among treatment groups
*Subjects enrolled <34 months (open window for 3 year visit) from the closeout date of the trial did not have potential to complete. 15 15

16. Baseline Characteristics
Mean age: 63 years
Diabetes type: 5% type 1, 95% type 2
Visual acuity (Snellen equivalent)
20/40 to 20/63: 58%
Worse than 20/63 to better than 20/200: 38%
20/200 to 20/320: 5%
OCT central subfield thickness
Mean: 424 microns
Range: 133 to 1164 microns

17. Baseline Characteristics
Pseudophakic: 21%
Prior macular laser: 61%
Retinopathy severity:
Microaneurysms only: <1%
Mild to moderately severe non-proliferative: 61%
Severe non-proliferative: 12%
Non-high risk proliferative: 24%
High risk proliferative: 3%

18. Treatment Prior to 2 Years
Laser
1 mg
4 mg
Mean number of treatments*
N=272
2.9
N=220
3.5
N=205
3.1
Non-randomized treatment†
N=330
13%
N=256
18%
N=254
* Includes only subjects with a 2 year visit
† e.g., IVT in laser group, or laser in IVT groups

19. Non-Randomized Treatments for DME Prior to 2 Years
Laser
1 mg
4 mg
Alternative* 16 23 17
Vitrectomy 12 6 8
Kenalog 4 3 2
Bevacizumab
Ranibizumab 1
Topical bromfenac
Alternative*/Vitrectomy
Alternative*/Kenalog
Alternative*/Bevacizumab
Vitrectomy/Kenalog
Vitrectomy/Bevacizumab
Kenalog/Bevacizuamb
Vitrectomy/Kenalog/Bevacizumab
* Alternative = IVT in laser group, or focal/grid laser in IVT groups

20. Number of Retreatments in 3rd Year*
Laser
N=115
1 mg
N=93
4 mg
N=98
75%
57%
46% 1
17%
24%
29% 2 7%
10%
21% 3 1% 9% 4%
* Among completers of the 3 year visit 20 20

21. Non-Randomized Treatments for DME During 3 Years*
Laser
N=115
1 mg
N=93
4 mg
N=98
Received alternative treatment † 6%
23%
20%
Received other treatment for DME ‡
13%
17%
11%
* Among completers of the 3 year visit
† laser in IVT groups, IVT in laser group
‡ primarily vitrectomy, Kenalog, bevacizumab 21 21

22. Primary Outcome: Mean Change in Visual Acuity at 2 Years
Mean Change in VA (letter score)
Laser
N=330
1 mg
N=256
4 mg
N=254 +1 -2 -3
Pairwise Comparisons
Mean Difference*
P value*
Laser vs. 1 mg
+3.5 letters
0.02
Laser vs. 4 mg
+4.6 letters
0.002
1 mg vs. 4 mg
+1.1 letters
0.49
* Adjusted for baseline VA and prior focal/grid laser

23. Change in VA from Baseline to 3 Years*
Laser
N=115
1 mg
N=93
4 mg
N=98
Mean change in VA 5
Improved >10 letters
44%
24%
37%
Worsened >10 letters
12%
26%
22%
Pairwise Comparisons
Mean Difference (95% CI)
Adjusted for baseline VA and prior focal/grid laser
Laser vs. 1 mg
+5.6 (+0.8, +10.4)
Laser vs. 4 mg
+4.7 (0.0, +9.5)
1 mg vs. 4 mg
-0.8 (-6.0, +4.3) 23
* Among completers of the 3 year visit 23

24. Median Visual Acuity in
Laser Treated Eyes
20/32
20/40
20/50
Visual
Acuity
Score
20/63
20/80 4 8 12 16 20 24
Months 24 24

25. Median Visual Acuity in Laser and 4 mg IVT Treated Eyes
20/32
20/40
20/50
Visual
Acuity
Score
20/63
20/80 4 8 12 16 20 24
Months 25 25

26. Median Visual Acuity in Laser and IVT Treated Eyes
20/32
20/40
# +
* #
* #
20/50
Visual
Acuity
Score #
20/63
20/80
P < 0.005
* Laser vs. 1mg
# Laser vs. 4mg
+ 1mg vs. 4mg 4 8 12 16 20 24
Months 26 26

27. Mean Visual Acuity Over 3 Years in All Eyes
20/32
20/40
Visual
Acuity
Score
20/50
20/63
20/80 4 8 12 16 20 24 28 32 36
Months 27 27

28. Mean Visual Acuity Limited to Completers of 3 Year Follow Up
20/32
20/40
Visual
Acuity
Score
20/50
20/63
20/80 4 8 12 16 20 24 28 32 36
Months 28 28

29. In All Eyes and in Completers
Mean Visual Acuity
In All Eyes and in Completers
20/32
20/40
Visual
Acuity
Score
20/50
20/63
20/80 4 8 12 16 20 24 28 32 36
Months 29 29

30. % Increased >10 Letters in Laser and 4mg Treated Eyes
34%
Months 30 30

31. % Increased >10 Letters in Laser and IVT Treated Eyes
Months 31 31

32. % Decreased >10 Letters in Laser and 4mg Treated Eyes
19%
Months

33. % Decreased >10 Letters in Laser and IVT Treated Eyes
Months

34. Change in VA from 2 Years to 3 Years*
2 year VA >=20/32
Laser
N=26
1mg
N=13
4mg
N=24
Mean change in VA -2 -4
Improved >10 letters
Worsened >10 letters
12% 8%
17%
* Among completers of both the 2 year and 3 year visit 34 34

35. Change in VA from 2 Years to 3 Years*
2 year VA <20/32
Laser
N=89
1mg
N=80
4mg
N=74
Mean change in VA 2 3 4
Improved >10 letters
23%
27%
Worsened >10 letters 9%
11%
15%
* Among completers of both the 2 year and 3 year visit 35 35

36. % Increased >10 Letters at 2 Years Stratified by Baseline VA13
129 13 92 12 94
N=189
149
149

37. % Decreased >10 Letters at 2 Years Stratified by Baseline VA
149
149
N=189 92 94 12 13
129 13

38. % Increased >10 Letters at 2 Years Stratified by Baseline CSF80 63 60 83
121
130 67 66

39. % Decreased >10 Letters at 2 Years Stratified by Baseline CSF66 60
130 67
N=166 80 63 83
121

40. % Increased >10 Letters at 2 Years Stratified by Prior Laser
102
198
158 96
154

41. % Decreased >10 Letters at 2 Years Stratified by Prior Laser96
N=132
102
154
158
198

42. Visual Acuity at 2 Years According to Lens Status
Mean Change in VA (letter score)
Laser
1 mg
4 mg
Overall
N=272
N=220
N=204 +2 -2 -4
Pseudophakic at 2 Yrs or Minimal or No Cataract at 2 Yrs
N=178
N=136
N=159 +3
Pseudophakic at Baseline
N=54
N=48
N=43 +2 -1
Includes only subjects with a 2 year visit

43. OCT Central Subfield (CSF) Thickening at 2 Years
Change in OCT CSF
Laser
N=220
1 mg
N=178
4 mg
N=162
Mean*
-139
-86
-77
Thickening Decreased >50%
67%
46%
48%
Thickness <250 microns
53%
34%
38%
*Pairwise Comparisons
P value
Laser v 1 mg
<0.001
Laser v 4 mg
1 mg v 4 mg
0.91

44. Change in CSF from Baseline to 3 Years*
Laser
N=111
1 mg
N=87
4 mg
N=89
Mean change (microns)
-175
-124
-126
<250 microns at 3 years
68%
43%
51%
* Among completers of the 3 year visit 44 44

45. Median Central Subfield Thickness in Laser Treated Eyes
(microns)
Months

46. Median Central Subfield Thickness in Laser and 4mg Treated Eyes
(microns)
Months

47. Median Central Subfield Thickness in Laser and IVT Treated Eyes
(microns)
Months

48. % CSF <250 microns in Laser and 4mg Treated Eyes
[Completed Visits only]
Another figure looking at CSF at follow-up visits as a binary outcome: % with CSF thickness < 250 microns at each visit.
This figure tells the same story as the previous: 4 mg group shows greater benefit at 4 months, at 1 year the laser and 4 mg groups were similar, by 2 years there was a greater proportion in the laser group with CSF thickness <250
Months

49. % CSF <250 microns in Laser and IVT Treated Eyes
[Completed Visits only]
Another figure looking at CSF at follow-up visits as a binary outcome: % with CSF thickness < 250 microns at each visit.
This figure tells the same story as the previous: 4 mg group shows greater benefit at 4 months, at 1 year the laser and 4 mg groups were similar, by 2 years there was a greater proportion in the laser group with CSF thickness <250
Months

50. Change in CSF from 2 Years to 3 Years*
2 year CSF <250
Laser
N=61
1mg
N=27
4mg
N=31
Mean change (microns) -3 12 27
<250 microns at 3 years
93%
67%
74%
Decreased >=20% and >=50 microns 7% 4%
13%
Increased >=20% and >=50 microns
22%
19%
* Among completers of both the 2 year and 3 year visit 50 50

51. Change in CSF from 2 Years to 3 Years*
2 year CSF >=250
Laser
N=50
1mg
N=59
4mg
N=54
Mean change (microns)
-79
-44
-84
<250 microns at 3 years
36%
31%
39%
Decreased >=20% and >=50 microns
54%
34%
46%
Increased >=20% and >=50 microns
10%
12%
13%
* Among completers of both the 2 year and 3 year visit 51 51

52. Median Decrease in CSF at 2 Years Stratified by Baseline CSF64 40 54
Median decrease in CSF thickness from baseline (microns) 58
N=139 49 55
108 98

53. Major Ocular Adverse Events During 2 Years of Follow-up
Laser
N=330
1 mg
N=256
4 mg
N=254
Endophthalmitis*
Pseudoendophthalmitis
Retinal detachment† 2 4
Retinal vein occlusion† 3 1
Retinal artery occlusion†
Anterior ischemic optic neuropathy†
Vitrectomy‡ 31 26 19
* 1 case of endophthalmitis occurred after vitrectomy, not related to study drug injection
† Judged not necessarily related to treatment
‡ Includes vitrectomy for diabetic macular edema, vitreous hemorrhage or other cause

54. Intraocular Pressure During 2 Years of Follow-up
Laser
N=330
1 mg
N=256
4 mg
N=254
Increase >10 mmHg 4%
16%
33%
IOP >30 mmHg 1% 9%
21%
Initiate IOP-lowering meds 8%
12%
30%
Open angle glaucoma 3%
Glaucoma procedure
2%*
Met any of the above
10%
20%
40%
*2 filtering surgeries, 1 laser trabeculoplasty, 1 ciliary body destruction

55. Intraocular Pressure During 3 Years of Follow-up*
Laser
N=115
1 mg
N=93
4 mg
N=98
Increase >10 mmHg any time 3%
17%
31%
Mean IOP at 3 yr visit (mmHg) 16 17
IOP >21 mmHg at 3 yr visit 5%
15%
10%
On IOP-lowering meds at 3 yr visit 8%
12%
30%
* Among completers of the 3 year visit 55 55

56. Cataract Surgery Prior to 2 Years
Laser
1 mg
4 mg
Phakic at Baseline
N=262
N=203
N=197
Cataract Surgery
13%
23%
51%

57. Cumulative Probability of Cataract Surgery* Over 3 Years
83%
46%
31% 4 8 12 16 20 24 28 32 36
Months
* Among phakic eyes at baseline 57 57

58. Discussion

59. Discussion
Visual acuity benefit in 4 mg IVT group at 4 months consistent with case series
No visual acuity differences by 1 year
Greater visual acuity benefit and fewer side effects (IOP & cataract) in laser group at 2 years
OCT results mirrored visual acuity results
Laser or IVT likely improves VA at 2 years compared with expected untreated course
Outcomes in same direction at 3 years

60. Both Laser and IVT Likely Superior to ETDRS Untreated (“Deferred Laser”) Subjects (Unpublished Data)
From ETDRS untreated group: subset of eyes with definite center thickening, worse than 20/32, and mild to moderate NPDR
2 Year Results
ETDRS Deferred
(Untreated)
N=235
Laser
N=330
1mg
N=256
4mg
N=254
Median change in VA -6
Improved >10 letters
12%
Worsened >10 letters
43%
Improved > 15 letters 5%
Worsened >15 letters
33% 60 60

61. Both Laser and IVT Likely Superior to ETDRS Untreated (“Deferred Laser”) Subjects (Unpublished Data)
From ETDRS untreated group: subset of eyes with definite center thickening, worse than 20/32, and mild to moderate NPDR
2 Year Results
ETDRS Deferred
(Untreated)
N=235
Laser
N=330
1mg
N=256
4mg
N=254
Median change in VA -6 +1 +2
Improved >10 letters
12%
25%
28%
Worsened >10 letters
43%
26%
Improved > 15 letters 5%
14%
17%
Worsened >15 letters
33%
20% 61 61

62. Both Laser and IVT Likely Superior to ETDRS Untreated (“Deferred Laser”) Subjects (Unpublished Data)
From ETDRS untreated group: subset of eyes with definite center thickening, worse than 20/32, and mild to moderate NPDR
2 Year Results
ETDRS Deferred
(Untreated)
N=235
Laser
N=330
1mg
N=256
4mg
N=254
Median change in VA -6 +4 +1 +2
Improved >10 letters
12%
31%
25%
28%
Worsened >10 letters
43%
19%
26%
Improved > 15 letters 5%
18%
14%
17%
Worsened >15 letters
33%
20%
All 3 groups likely superior to expected untreated course of DME 62 62

63. Consistency in Subgroups
No clear benefit of IVT over laser:
With or without prior laser
Across baseline OCT thickness
Across baseline visual acuities
Less benefit with IVT compared with laser not likely due to steroid-induced lens changes
Benefit favored laser for pseudophakic eyes or eye with no/minimal cataract
Most subjects in 4 mg IVT had cataract surgery by 36 months
OCT effects presumably independent of cataract

64. Study Design Strengths and Potential Limitations
Treatment groups balanced on baseline factors
Unmasking of assignment unlikely to bias OCT and electronic VA results
Consistency of VA and OCT results
Completion rate similar among groups
Results consistent among multiple analyses to handle missing data
2 year results consistent with similar cohorts in ETDRS and in prior DRCR.net trial

65. Assessment of Bias Relevant to Year 3 Results
Baseline characteristics similar among completers and non-completers
Average VA over follow-up about 4 letters worse in non-completers with potential to complete than in completers
3 year VAs are likely slight overestimates
Treatment group comparison does not appear affected by missing data
2 methods of VA imputation yielded same results 65 65

66. Results Consistent with ETDRS Laser Group (Unpublished Data)
From ETDRS laser group: subset of eyes with definite center thickening, VA worse than 20/32, and mild or moderate NPDR
2 Year Results
ETDRS Laser
N=114
DRCR.net
Laser
N=330
Median change in VA +4
Improved >10 letters
29%
31%
Worsened >10 letters
16%
19%
Improved >15 letters
13%
18%
Worsened >15 letters
11%
14% 66 66

67. Results Consistent with Similar Cohort in Prior DRCR
Results Consistent with Similar Cohort in Prior DRCR.net Trial (Unpublished Data)
From prior study evaluating different laser regimens: subset of focal/grid laser group eyes 20/40 or worse with central subfield thickness >250 microns
2 Year Results
Prior DRCR.net
Laser
N=46
Current DRCR.net
N=330
Median change in VA +6 +4
Improved >10 letters
37%
31%
Worsened >10 letters 9%
19% 67

68. Importance of Focal/Grid Photocoagulation
Results re-affirm importance of laser in management of DME
It was widely believed that the ETDRS showed laser reduces vision loss, but did not improve VA however majority of eyes in ETDRS were better than 20/40 (no room for substantial improvement)

69. Future Studies Needed
Further evaluate course of focal/grid laser treatment for DME
Determine whether combining focal/grid and IVT results in better outcomes for DME
Determine whether other treatments (e.g., anti-VEGF), with or without focal/grid, result in better outcomes for DME

70. DRCR Network Protocols (as of November 24, 2008)
# of Subjects
Pilot Study of Laser Photocoagulation for DME (A)
263
Randomized Trial: Intravitreal Steroids vs Focal Laser for DME (B)
693
Temporal Variation in OCT Measurements in DME (C)
107
Evaluation of Vitrectomy for DME (D)
241
A Pilot Study of Peribulbar Triamcinolone Acetonide for DME (E)
113
Observational Study: Development of DME After PRP (F)
155
Subclinical Diabetic Macular Edema Study (G) 68
Phase 2 Randomized Trial of Bevacizumab for DME (H)
121
Laser-Ranibizumab-Triamcinolone for DME (I)
666
Laser-Ranibizumab-Triamcinolone for PDR + DME (J)
214
Laser Response Protocol (K)
128
DRCR Network Study Subject Total
2,769

71. Conclusion
Focal/grid is more effective than IVT with fewer side effects at 2 years
Outcomes in same direction at 3 years
Laser or IVT likely improve visual acuity over 2 years compared with expected untreated course
Focal/grid currently most effective treatment for patients with DME
Focal/grid currently benchmark for clinical trials for DME

72. Conclusions
From year 2 to 3, VA improved more often than it worsened, and residual DME tended to lessen
Additional laser infrequent in year 3
Treatment group differences at 2 yrs in the same direction at 3 yrs, slightly favoring the laser group
Most eyes treated with 4mg IVT will require cataract surgery
No long-term benefit of IVT for DME compared with focal/grid laser

73. For further information and all DRCR Network financial disclosures,
Thank You
88 clinical study sites
Subjects who volunteered to participate in this trial
DRCR Network Data and Safety Monitoring Committee
Allergan (provided drug supplies; collaborated with Network through DRCR.net Industry Collaboration Guidelines in a manner consistent with Network's dedication to academic integrity and clinical trial performance)
Juvenile Diabetes Research Foundation (JDRF)
DRCR Network investigators and staff
For further information and all DRCR Network financial disclosures,
go to 73 73

74. Extra Slides

75. Baseline Testing
Assessment of eligibility and randomization (treatment must be given on day of randomization) may require >1 visit
E-ETDRS best-corrected visual acuity (within 8 days of randomization)
OCT (within 21 days)
Ocular examination with IOP and DFE (within 21 days)
Lens assessment (within 21 days)
Fundus photographs (within 21 days)
Blood pressure measurement (within 21 days)
HbA1c (3 months before or within 3 weeks)

76. Retreatment Criteria Definitions
Success: Treatment has been successful if:
Center of macula nearly flat (<225 microns on OCT central subfield); or
VA better than 20/25 (79 or more letters)
Improvement: Investigator’s opinion:
(e.g. >50% decrease in retinal thickening AND further spontaneous improvement in macular edema might be expected)

77. Retreatment Criteria Definitions
Adverse events and maximal treatment: Retreatment may be deferred if:
The patient had an IOP elevation after a previous treatment that required treatment or
Maximal laser treatment has been applied and further treatment is contraindicated
Futility: Additional treatment is futile over an 8 or more month period (at least two treatments) if there is NOT borderline improvement defined as:
Increase in VA of at least 5 letters or
Decrease in calculated retinal thickening based on OCT findings (> 50 microns and represents at least a 20% reduction)

78. Alternative Treatment
It was preferable that eyes assigned to treatment with laser not be treated with intravitreal steroid and vice versa
However, an eye could have been treated with alternative treatment when it has experienced:
15 letter or more decrease in visual acuity score from baseline that is present at two consecutive 4 month visits, AND
Decrease in visual acuity is due to persistent or recurrent macular edema (note: center of macula should not be considered flat if OCT central subfield is >225 microns)

79. Treatments prior to 1 yr Laser N=270* 1 mg N=218* 4 mg N=201*
Baseline only
25%
15%
Baseline + 4 mos only
28%
26%
21%
Baseline + 8 mos only 8%
10%
4 mos +8 mos only
<1%
Baseline + 4 mos +8 mos
38%
49%
33%
Mean + SD
2.1 ± 0.8
2.3 ± 0.7
*Includes eyes completing the 2 year visit.

80. # Treatments prior to 2 yrs
Laser
N=270*
1 mg
N=218*
4 mg
N=201* 1
19%
11% 2
24%
16%
25% 3 4
18%
21% 5
10%
14%
13% 6 4% 6%
Mean + SD
2.9 ± 1.4
3.5 ± 1.5
3.1 ± 1.4
*Includes eyes completing the 2 year visit.

81. % Increased >15 Letters at Follow-up Visits
20%
Months

82. % Decreased >15Letters at Follow-up Visits
13%

83. Visual Acuity at 2 Years: N=147 subjects with 2 study eyes
Mean Paired Difference in
Change in VA
Laser + 1 mg (N=72)
4.4*
Laser + 4 mg (N=75)
4.5*
* Favoring laser group

84. Gillies et al. Ophthalmology 2006
69 eyes of 43 subjects with DME and VA 20/30 or worse
Randomized to 4 mg IVT or sham injections (no laser group)
Beneficial effect of IVT at 2 years
The study did not compare IVT to laser, but does further support a positive long-term effect of triamcinolone

85. Gillies et al. Ophthalmology 2006
Treatment Prior to 2 Year Visit
Placebo
N=29
4 mg IVTA
N=31
Mean Number of Injections (TA or sham)
1.8
2.6
Number of Laser Treatments 16 1