| Summary: | You-Xin Chen,1 Xiao-Xin Li,2 Young Hee Yoon,3 Xiaodong Sun,4 Yury Astakhov,5 Gezhi Xu,6 Hui Wang,7 Xiaowei Ren,8 Friedrich Asmus9 On behalf of the VIVID-East investigators1Department of Ophthalmology, Peking Union Medical College, Beijing, People’s Republic of China; 2Ophthalmology Department, People’s Eye Center of Peking University People’s Hospital, Beijing, People’s Republic of China; 3Department of Ophthalmology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea; 4Department of Ophthalmology, Shanghai Jiao Tong University School of Medicine, Shanghai, People’s Republic of China; 5Department of Ophthalmology, Pavlov First St. Petersburg State Medical University, St. Petersburg, Russia; 6Department of Ophthalmology and Vision Sciences, Eye and ENT Hospital, Shanghai Medical College, Fudan University, Shanghai, People’s Republic of China; 7Clinical Development, Ophthalmology, Bayer Healthcare Inc, Shanghai, People’s Republic of China; 8Statistics and Data Insights, Bayer Healthcare Inc, Beijing, People’s Republic of China; 9University Hospital of Tübingen, Tübingen, GermanyCorrespondence: Friedrich AsmusCenter for Neurology, University Hospital of Tübingen, Hoppe-Seyler Strasse 3, Tübingen, GermanyTel +49 179 746 3010Email friedrich.asmus@gmail.comPurpose: 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, intravitreal aflibercept, diabetic macular edema
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