Diabetic macular edema treated with intravitreal aflibercept injection after treatment with other anti-VEGF agents (SWAP-TWO study): 6-month interim analysis

Amy S Babiuch, Thais F Conti, Felipe F Conti, Fabiana Q Silva, Aleksandra Rachitskaya, Alex Yuan, Rishi P Singh, Amy S Babiuch, Thais F Conti, Felipe F Conti, Fabiana Q Silva, Aleksandra Rachitskaya, Alex Yuan, Rishi P Singh

Abstract

Background: Diabetic macular edema (DME) is an important cause of vision loss and despite the anatomical and functional improvement achieved with treatment, there are reports of persistent DME regardless of continuous anti-VEGF therapy. The purpose of this study is to examine the effect of patients with DME previously treated with other anti-VEGF agents who are transitioned to intravitreal aflibercept (IAI) on a fixed dosing regimen.

Methods: This prospective study included 20 patients presenting with DME with a history of previous anti-VEGF treatment with ranibizumab or bevacizumab. Patients received a 2 mg (0.05 mL) IAI every 4 weeks until no evidence of fluid by optical coherence tomography (OCT) followed by a fixed dosing schedule of 2 mg IAI once every 8 weeks through 24 months. There was a pre-planned interim analysis of the mean absolute change from baseline central foveal thickness at month 6 as measured by OCT. Secondary outcomes included mean change from baseline in ETDRS visual acuity and anatomic parameters. Optical Coherence tomography angiography (OCTA) capillary perfusion density (CPD) after transitioning to IAI therapy were also reported.

Results: Average central subfield thickness on OCT at baseline was 419.7 ± 92.0 and improved to 303.8 ± 73.1 at 6-months (p < 0.001). At 6 months after IAI treatment, BCVA increased + 1.5 letters from baseline (p = 0.38). OCTA CPD analysis revealed significant increase from baseline in the foveal avascular zone in non-proliferative diabetic retinopathy group (p = 0.02).

Conclusions: Patients with prior anti-VEGF therapy who were transitioned to IAI therapy revealed significant anatomic improvements through 6 months.Trial registration Treatment of Diabetic Macular Edema With Aflibercept in Subjects Previously Treated With Ranibizumab or Bevacizumab (SwapTwo), Trial registration number: NCT02559180. Date of registration: September 24, 2015.https://ichgcp.net/clinical-trials-registry/NCT02559180.

Conflict of interest statement

Competing interestsTFC, FFC, and FQS have no competing interest to disclosure; ASB: received grants from Regeneron, personal fee from VINDICO and MCME Global; AR: received personal fee from Alcon, Allergan, and Zeiss; AY: received grants from Regeneron; RPS: received grants and personal fees from Regeneron, Genentech/Roche, Apellis, Optos, Zeiss, Biogen, and Alcon/Novartis outside the submitted work.

Figures

Fig. 1
Fig. 1
Flow chart
Fig. 2
Fig. 2
Visit-to-visit change in central subfield thickness
Fig. 3
Fig. 3
Optical coherence tomography and optical coherence tomography angiography of a patient with epiretinal membrane at baseline. A OCT from a patient with epiretinal membrane at baseline. B Patient 6 month after switching to IAI. C Example of En Face OCT and full retina capillary perfusion density analysis from same patient presented with ERM at baseline. D Example of En Face OCT and full retina capillary perfusion density analysis 6 month after switching to IAI
Fig. 4
Fig. 4
Visit-to-visit change in best correct visual acuity. ETDRS early treatment diabetic retinopathy study
Fig. 5
Fig. 5
Visual acuity changes in patients noted by month 6. BCVA best-corrected visual acuity

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