Two-Year Outcomes of Anti-VEGF Treatment for Diabetic Macular Edema
Analysis of early response to anti-VEGF therapy for diabetic macular edema, highlighting the relationship between visual acuity changes at different time points and the variability in long-term outcomes. Data from Protocol T and mean changes in visual acuity over two years with aflibercept are discussed.
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Early Response to Anti-Vascular Endothelial Growth Factor and Two-Year Outcomes Among Eyes with Diabetic Macular Edema in Protocol T
Background Analysis by Gonzalez et al of DRCR Network Protocol I data showed a strong relationship between change in VA from baseline to 12-week visit with change in VA from baseline to 1- or 3-year visits among eyes treated with ranibizumab for DME ~25% of eyes with <5-letter gain at 12 weeks gained 10 letters at 3 years ~75% of eyes with 10-letter gain at 12 weeks gained 10 letters at 3 years Estimates not precise enough to determine course of vision gain or loss for an individual eye in 2018 Nor do they imply that switching to alternative therapies such as corticosteroids after 3 injections would improve outcomes What about data from Protocol T? 2
Mean Change in VA Over 2 Years Aflibercept Group 20 Mean Change in VA Letter Score 15 10 5 +6.2 0 <5 letters -5 12 0 52 104 Weeks Mean Change in VA at 12 Weeks 4
Mean Change in VA Over 2 Years Aflibercept Group 20 Mean Change in VA Letter Score +18.1 15 +9.1 10 5 +6.2 0 <5 letters 26% (54) 25% (53) 49% (102) 5 to 9 letters 10 letters -5 0 52 104 12 Weeks Mean Change in VA at 12 Weeks 5
Mean Change in VA Over 2 Years Aflibercept Group than eyes gaining >10 letters at 3 months But, there was substantial individual variability of long-term change in VA Eyes gaining <5 letters at 3 months had less VA improvement at 2 years, on average, 20 Mean Change in VA Letter Score +18.1 15 +9.1 10 5 +6.2 0 <5 letters 26% (54) 25% (53) 49% (102) 5 to 9 letters 10 letters -5 0 52 104 12 Weeks Mean Change in VA at 12 Weeks 6
Mean Change in VA Over 2 Years Aflibercept Group 20 Mean Change in VA Letter Score 15 10 5 +6.2 0 <5 letters -5 12 0 52 104 Weeks Mean Change in VA at 12 Weeks 7
Mean Change in VA Over 2 Years Aflibercept Group Change in VA at 2-Years 20 Mean Change in VA Letter Score 15 10 5 +6.2 0 <5 letters -5 12 0 52 104 Weeks Mean Change in VA at 12 Weeks 8
Mean Change in VA Over 2 Years Aflibercept Group 20 Mean Change in VA Letter Score +18.1 15 +9.1 10 5 +6.2 0 <5 letters 26% (54) 25% (53) 49% (102) 5 to 9 letters 10 letters -5 0 52 104 12 Weeks Mean Change in VA at 12 Weeks 9
Mean Change in VA Over 2 Years Bevacizumab Group 20 Mean Change in VA Letter Score +17.4 15 10 +7.7 5 +4.6 0 <5 letters 37% (77) 30% (62) 33% (68) 5 to 9 letters 10 letters -5 0 52 104 12 Weeks Mean Change in VA at 12 Weeks 10
Mean Change in VA Over 2 Years Ranibizumab Group 20 Mean Change in VA Letter Score +17.3 15 +9.7 10 +9.0 5 0 <5 letters 35% (69) 28% (55) 38% (76) 5 to 9 letters 10 letters -5 0 52 104 12 Weeks Mean Change in VA at 12 Weeks 11
Change in VA from Baseline at 2 Years Eyes gaining <5 letters at 3 months had less VA improvement at 2 years, on average, than eyes gaining >10 letters at 3 months But, there was substantial individual variability of long-term change in VA <5-Letter VA Gain at 12 Weeks 100% 31 % of Eyes at 2 Years 80% 42 47 60% 19 10 24 40% 50 48 20% 29 0% 12 <5 letters 5 to 9 letters 10 letters
Change in VA from Baseline at 2 Years Eyes gaining <5 letters at 3 months had less VA improvement at 2 years, on average, than eyes gaining >10 letters at 3 months But, there was substantial individual variability of long-term change in VA <5-Letter VA Gain at 12 Weeks 10-Letter VA Gain at 12 Weeks 100% 100% 31 % of Eyes at 2 Years % of Eyes at 2 Years 80% 80% 42 47 77 60% 60% 79 19 84 10 24 40% 40% 50 48 20% 20% 11 29 17 11 9 6 5 0% 0% 13 <5 letters 5 to 9 letters <5 letters 5 to 9 letters 10 letters 10 letters
VA Letter Score at 2 Years <5-Letter VA Gain at 12 Weeks 100% % of Eyes at 2 Years 80% 42 60% 40% 44 20% 15 0% Few eyes with <5-letter gain at 12 weeks are 20/50 or worse at 2 years 20/50 or worse 20/25 or better 20/32 to 20/40 14
VA Letter Score at 2 Years <5-Letter VA Gain at 12 Weeks 10-Letter VA Gain at 12 Weeks 100% 100% % of Eyes at 2 Years % of Eyes at 2 Years 80% 80% 42 69 60% 60% 40% 40% 44 17 20% 20% 15 15 0% 0% 20/50 or worse 20/25 or better 20/32 to 20/40 20/50 or worse 20/25 or better 20/32 to 20/40 15
VA Letter Score at 2 Years <5-Letter VA Gain at 12 Weeks 10-Letter VA Gain at 12 Weeks 100% 100% % of Eyes at 2 Years % of Eyes at 2 Years 37 80% 80% 42 49 55 63 69 60% 60% 41 40% 40% 44 31 23 19 17 20% 20% 23 22 20 19 15 15 0% 0% 20/50 or worse 20/25 or better 20/32 to 20/40 20/50 or worse 20/25 or better 20/32 to 20/40 16
Change in VA Baseline at 2 Years by OCT Response at 12 Weeks <10% OCT Response at 12 Weeks 20% OCT Response at 12 Weeks 100% 100% % of Eyes at 2 Years % of Eyes at 2 Years 39 80% 80% 56 58 62 66 66 60% 60% 17 40% 40% 22 23 21 14 15 44 20% 20% 22 20 20 19 19 0% 0% 18 <5 letters 5 to 9 letters <5 letters 5 to 9 letters 10 letters 10 letters
Multivariable Analysis of 2-Year Change in VA from Baseline Aflibercept N = 193 Bevacizumab N = 180 P-value .02 <.001 .44 Ranibizumab N = 178 Characteristic <.001 <.001 .23 <.001 <.001 .35 Baseline VA 12-wk VA change Baseline CST 12-wk CST relative change .21 .22 .02 .38 .29 .26 R-squared* *Proportion of the variability in 2-year change in VA from baseline explained by these characteristics 19
Conclusions Visual acuity response at 12 weeks following 3 monthly injections was associated with 2-year outcomes Regardless of anti-VEGF agent used (AFL, RBZ, BEV) However, a suboptimal response (<5-letter gain) after 3 injections did not preclude further meaningful vision improvement (i.e., 2-line gain) without switching therapy About 2/3 of the variation in 2-year outcomes remains unexplained Same % of eyes end up 20/40 or better (e.g., about 85% with aflibercept) whether <5- letter or >10-letter gain after 3 injections Little evidence to suggest switching from the DRCR.net anti-VEGF treatment regimen for DME after 3 or 6 injections will result in better vision results (e.g., Protocol U) than continuing the DRCR.net treatment regimen Future studies needed comparing DRCR.net anti-VEGF treatment regimen for DME with alternative regimens 22
