Intravitreal Aflibercept versus Laser Photocoagulation in Asian Patients with Diabetic Macular Edema: The VIVID-East Study

Abstract

Purpose: The prevalence of diabetes and diabetes-related complications, including diabetic macular edema (DME), is increasing in Asia and worldwide.

Methods: VIVID-East was a 12-month, double-masked, randomized, active-controlled, Phase 3 trial (NCT01783886) enrolling adult patients (aged ≥18 years) with DME at 25 centers across China, Hong Kong, Republic of Korea, and Russia. Eyes were randomized 1:1:1 to 2 mg intravitreal aflibercept (IVT-AFL) every 4 weeks (2q4; N=127), 2 mg IVT-AFL every 8 weeks (after 5 initial monthly doses from baseline to week 16) with sham injections on nontreatment visits (2q8; N=127), or macular laser photocoagulation at baseline and sham injections at every visit (laser control group; N=124). The primary efficacy endpoint was mean change in best corrected visual acuity (BCVA) from baseline to week 52.

Results: Compared with baseline, at week 52 the mean (SE) BCVA in the 2q4 and 2q8 groups gained +13.6 (0.9) and +13.1 (1.0) letters, respectively, versus -0.5 (1.4) letters in the laser group (P<0.0001 for both). A significantly higher proportion of patients treated with IVT-AFL (2q4 and 2q8) achieved a ≥10-letter or ≥15-letter gain compared with laser (both P<0.0001) (≥10-letter gain: 70.9%, 62.7%, and 23.4%, respectively; ≥15-letter gain: 43.3%, 36.5%, and 12.1%, respectively). Mean reduction in central retinal thickness from baseline to week 52 was significantly greater with IVT-AFL versus laser treatment. Incidence of treatment-emergent adverse events was low and similar across groups; conjunctival hemorrhage (11.8%), retinal hemorrhage (8.7%), retinal aneurysm (7.5%), and retinal exudates (5.5%) being the most frequently reported. Visual and anatomic outcomes in the Chinese subgroup were consistent with the overall population.

Conclusion: IVT-AFL treatment resulted in significant visual and anatomic improvements in Asian patients with DME. Treatment benefits observed in the overall study population were mirrored in the subgroup of Chinese patients, who made up the largest population group in the study.

Study registration: NCT01783886.

Keywords: Asia; Chinese; diabetic macular edema; intravitreal aflibercept.

Conflict of interest statement

YHY reports grants and/or personal fees from Allergan, Bayer, Alcon, and Roche, outside the submitted work. HW is an employee of Bayer HealthCare Inc, Pudong District, Shanghai, China. XR is an employee of Bayer HealthCare Inc, Chaoyang District, Beijing, China. FA was an employee of Bayer Pharmaceuticals, Berlin, Germany at the time this manuscript was written, he is now an employee of ProQR Therapeutics from Oct 01, 2019 onwards. The authors report no other conflicts of interest in this work.

© 2020 Chen et al.

Figures

Figure 1

Consolidated standards of reporting trial (CONSORT) diagram of study participant disposition. Abbreviations: 2q4, 2 mg every 4 weeks; 2q8, 2 mg every 8 weeks; IVT-AFL, intravitreal aflibercept.

Figure 2

Change in BCVA from baseline to week 52 in the (A) Overall population and (B) Chinese subgroup. Abbreviations: 2q4, 2 mg every 4 weeks; 2q8, 2 mg every 8 weeks; BCVA, best corrected visual acuity; ETDRS, Early Treatment Diabetic Retinopathy Study; IVT-AFL, intravitreal aflibercept; LOCF, last observation carried forward.

Figure 3

Proportion of patients gaining ≥15 ETDRS letters (A) or a ≥2-step improvement in DRSS (B) from baseline to week 52. aP<0.0001. Abbreviations: 2q4, 2 mg every 4 weeks; 2q8, 2 mg every 8 weeks; DRSS, Diabetic Retinopathy Severity Scale; ETDRS, Early Treatment Diabetic Retinopathy Study; IVT-AFL, intravitreal aflibercept.