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The Diabetic Retinopathy Clinical Research Network 5-Year Follow-up of a Randomized Trial Evaluating Ranibizumab Plus Prompt versus Deferred Laser for Diabetic Macular Edema
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Background: Protocol I Previously reported intravitreous ranibizumab with prompt or deferred laser more effective through at least 2 years compared with laser 3-year comparison of ranibizumab groups concluded prompt laser was no better and possibly worse than deferred laser Study extended to 5 years to assess longer- term course of DME treated with ranibizumab To report the comparison of ranibizumab groups through 5 years 2
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3 Completion of 5 Year Visit Ranibizumab + Prompt Laser Ranibizumab + Deferred Laser Eyes originally randomized N = 180N = 181 Completed 5 Year (excl deaths)69% (76%)61% (74%) Death prior to 5 Year9%17% Discontinued/Dropped prior to 5 Year Includes pts who did not consent to extension 21%22% Eyes in the extension study N = 132N = 136 Completed 5 Year (excl deaths)94% (97%)82% (92%) Death prior to 5 Year3%11% Dropped prior to 5 Year3%7%
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Ranibizumab + prompt laser Ranibizumab + deferred laser Completers Non- completersCompleters Non- completers N = 124N = 56N = 111N = 70 Median Age63656365 Prior PRP33%11%21%20% Lens Status Phakic73%61% 75%63% Median VA (letter score) 65 6762 Median CST (µm)375372394378 Mild/Moderate/HR PDR34%27%24%37% 4 Baseline Characteristics of Completers vs Non-Completers
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5 Visits Prior to 5 Year * Ranibizumab + Prompt Laser N=124 Ranibizumab + Deferred Laser N=111 Median # of visits in year 1 13 Median # of visits in year 2 810 Median # of visits in year 3 78 Median # of visits in year 4 56 Median # of visits in year 5 45 Median # of visits prior to 5 year visit 3840 * Only eyes that completed 5 year visit
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Treatments 6
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7 Injections Prior to 5 Year * *Only eyes that completed 5 year visit Ranibizumab + Prompt Laser N=124 Ranibizumab + Deferred Laser N=111 Median # of injections in year 1 89 Median # of injections in year 2 23 Median # of injections in year 3 12 Median # of injections in year 4 01 Median # of injections in year 5 00 Median # of injections prior to 5 year visit 1317 % of eyes that received >1 injection in year 4 46%55% % of eyes that received >1 injection in year 5 38%48%
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8 Focal/Grid Laser Prior to 5 Years * Ranibizumab + Prompt Laser N = 124 Ranibizumab + Deferred Laser N = 111 % of eyes that did NOT receive laser treatments prior to the 5 year visit 056% Median # laser treatments prior to the 5 year visit 30 * Only eyes that completed 5 year visit
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Visual Acuity 9
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Mean Change in Visual Acuity * at Follow-up Visits 10 +7.2 +9.8
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11 Change in Visual Acuity at 5 Years Change in Visual Acuity (letters) Ranibizumab + Prompt Laser N = 124 Ranibizumab + Deferred Laser N = 111 Estimated Means*+7.2+9.8 Estimated Diff* (95% CI)* [P-Value]* [adjusted P-Value]† -2.6 (-5.5 to +0.4) [P = 0.09] [P = 0.15] *truncated to ± 30 letters, based on longitudinal analyses adjusting for baseline VA †Additional adjustment for potential confounders (baseline lens status, CSF, DR severity, prior PRP, age)
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Distribution of VA Change at 5 Years 12 Change in Visual Acuity (letters) Ranibizumab + Prompt N = 124 Ranibizumab + Deferred N = 111 >15 letter gain27%38% RR (95%CI) P value 1.47 (1.04, 2.09) 0.03 >10 letter gain46%58% RR (95%CI) P value 1.27 (1.01, 1.60) 0.04 >15 letter loss6%5% RR (95%CI) P value 0.96 (0.34, 2.72) 0.94 >10 letter loss9%8% RR (95%CI) P value 0.91 (0.40, 2.10) 0.83
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Change in VA Over 5 Years Stratified by Baseline VA 13 Test for interaction at 5 Year time point: P = 0.001 Test for interaction from longitudinal model: P = 0.004
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14 Percent of Eyes with VA 20/40 (Letter Score 69) or Better
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15 Percent of Eyes with VA 20/200 (Letter score 38) or Worse
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Retinal Thickening 16
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Mean Change in CSF Thickening at Follow-up Visits 17
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18 Change in Retinal Thickness at 5 Years* *Based on a longitudinal model adjusting for baseline CSF and VA †Additional adjustment for potential confounders (baseline lens status, DR severity, prior PRP, age) Ranibizumab + Prompt Laser N = 124 Ranibizumab + Deferred Laser N = 111 Estimated Mean change*-167-165 Estimated Difference* (95% CI) [P-Value] [adjusted P-Value]† -8 (-30 to +15) [P = 0.48] [P = 0.53]
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19 Reduced VA and Thickened at 5 Years Ranibizumab + Prompt Laser N = 124 Ranibizumab + Deferred Laser N = 111 VA 20/32 or worse and CSF >250 µm 23%24%
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Endophthalmitis Ranibizumab + Prompt Laser treatment Ranibizumab + Deferred Laser treatment N = 187 eyesN = 188 eyes Number (%) cases 1 (1%)2 (1%) N=2557 injectionsN=3176 injections Rate per injection0.04%0.06% 20 N’s include ALL randomized eyes
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Summary VA gain at 1 year was maintained to 5 years concomitant with diminishing need for treatment over time Adding laser at initiation of ranibizumab was no better than deferring laser at least 24 weeks Deferring laser may be associated with more VA gain through 5 years, especially in eyes with worse VA at baseline 21
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Summary Over half assigned to deferral never received laser through 5 years Eyes assigned to prompt laser needed fewer injections over 5 years Few eyes in either group had substantial VA loss About 1/3 still thickened more work to be done 22
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Discussion – Observed Difference in VA in Favor of Deferred Laser May be related to greater number of ranibizumab injections during follow-up in the deferred group May be related to potentially destructive effect of laser at baseline in the prompt group (subsequently given to fewer than half in deferred group) Similar results noted in RESTORE through 1 year 23
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Discussion - Limitations (Incomplete Data) Excluding deaths, about a quarter of all randomized eyes did not complete the 5-year visit, in both ranibizumab groups. Mostly pts choosing not to continue in the extension study Model adjusted for imbalances in baseline completer characteristics that could be related to VA outcome If dropout is related to what was observed prior to loss to follow-up (last VA), then the longitudinal model accounts for this (estimates are based on projected trajectories) It is not possible to know whether incomplete data were related to unobserved factors and could have affected the results in either direction 24
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Conclusions Differences in VA may be real, in particular for eyes with worse baseline VA, but deferral may require more injections over 5 years to achieve results seen in this report, and thus may entail greater costs (cost effectiveness analysis is beyond scope of study) Results apply to patients similar to those enrolled in this trial and following same retreatment criteria. Eyes initiating ranibizumab (with prompt or deferred laser) can maintain vision gains obtained by first year through 5 years with minimal treatment after 3 years 25
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The Diabetic Retinopathy Clinical Research Network Thank You
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