Purpose: To determine characteristics of eyes achieving absence of diabetic macular edema (DME) and very good vision after treatment with bevacizumab first, with a switch to aflibercept, versus aflibercept monotherapy using Diabetic Retinopathy Clinical Research Retina Network Protocol AC data.
Design: Post hoc analysis.
Subjects: Patients in the Diabetic Retinopathy Clinical Research Protocol AC.
Methods: Bevacizumab-first subjects were assigned to "bevacizumab-switch" or "bevacizumab-only" groups, and aflibercept monotherapy subjects were assigned to "aflibercept-switch-eligible" or "aflibercept-only" groups, based on predefined switch criteria. Absence of DME was defined as normal central subfield thickness per device-specific thresholds and very good vision as visual acuity ≥20/25 or ≥80 ETDRS letters.
Main outcome measures: Proportion of eyes in each group achieving absence of DME and very good vision and maintaining absence of DME and very good vision throughout follow-up.
Results: Of 312 patients enrolled in Protocol AC, 284 with sufficient follow-up were included. In the aflibercept monotherapy cohort, 81.4% (118/145) achieved absence of DME versus 71.9% (100/139) in the bevacizumab-first cohort (P = 0.068), within a mean time of 16.2 versus 30.8 weeks, respectively (P < 0.001). In the aflibercept monotherapy cohort, 68.3% (99/145) achieved very good vision versus 65.5% (91/139) in the bevacizumab-first cohort (P = 0.705), within a mean time of 24.6 versus 36.6 weeks, respectively (P = 0.002). In the aflibercept-only group, 94.9% (93/98) achieved absence of DME versus 84.1% (37/44) in the bevacizumab-only group (P = 0.048), in 11.8 versus 13.5 weeks (P = 0.444). The aflibercept-switch-eligible group had similar proportions achieving absence of DME and very good vision in similar times compared with the bevacizumab-switch group. The aflibercept-only group had a similar proportion achieving very good vision in a similar time compared with the bevacizumab-only group.
Conclusions: Aflibercept monotherapy eyes achieved absence of DME significantly sooner by 14.6 weeks and very good vision by 12 weeks compared to the other group. The proportion achieving absence of DME and very good vision was similar between the 2 cohorts. In eyes never meeting switch criteria, a significantly greater proportion in the aflibercept-only group achieved absence of DME compared with the bevacizumab-only group.
Financial disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
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