研究单位：[1]Bayer[2]Regeneron Pharmaceuticals[3]The Second Hospital of Anhui medical university,Hefei,Anhui,China,230601[4]Lanzhou University Second Hospital,Lanzhou,Gansu,China,730030[5]Guangdong Provincial Hospital of TCM,Guangzhou,,Guangdong,China,510120[6]Guangzhou First People Hospital,Guangzhou,Guangdong,China,510180[7]Zhujiang Hospital of Southern Medical University,Missing,Guangdong,China,510280[8]The People''s Hospital of Guangxi Zhuang Autonomous Region,Nanning,Guangxi,China,530021[9]The First Affiliated Hospital of Harbin Medical University,Harbin,Heilongjiang,China,150001[10]Luoyang Third People''s Hospital,Luoyang,Henan,China,471002[11]Renmin Hosp., Wuhan Univ.,Wuhan,Hubei,China,430040[12]Nanjing First Hospital,Nanjing,Jiangsu,China,210006[13]Affiliated hospital of Nantong university,Nantong,Jiangsu,China,226006[14]The First Affiliated Hospital of NanChang University,Nanchang,Jiangxi,China,330006[15]The Second Affiliated Hospital of Nanchang University,Nanchang,Jiangxi,China,330200[16]The First Hospital of Jilin University,Changchun City,Jilin,China,130061[17]The Second Hospital of Jilin University,Changchun,Jilin,China,130000[18]Aier Eye Hospital(SHENYANG),Shenyang,Liaoning,China[19]Liaocheng People''s Hospital,Liaocheng,Shandong,China,252000[20]Shanxi Bethune Hospital,Taiyuan,Shanxi,China,030032[21]Sichuan University West China Hospital,Chengdu,Sichuan,China,MISSING[22]Taizhou Hospital of Zhejiang Province,Taizhou,Zhejiang,China,317099[23]ZheJiang Provincial People''s Hospital,Zhejiang,Zhejiang,China,314408[24]Zhengzhou Second People''s Hospital,Erqi,Zhengzhou,China,450015[25]Beijing Aier Intech Eye Hospital,Beijing,China,100000[26]Beijing Friendship Hospital, Capital Medical University,Beijing,China,100050[27]Capital Medical University (CMU) - Beijing Tongren Hospital,Beijing,China,100062[28]Beijing Hospital,Beijing,China,100730[29]Central South University - The Second Xiangya Hospital,Changsha,China,410007[30]Chengdu Aier Ophthalmology Hospital,Chengdu,China,610041[31]Chengdu University of Traditional Chinese Medicine - Teaching Hospital (Sichuan Province Traditional Chinese Medicine Hospital),Chengdu,China,610072[32]The First Affiliated Hospital of Chongqing Medical Universit,Chongqing,China,400042[33]Fujian Medical University - The First Affiliated Hospital,Fuzhou,China,350005[34]Guangzhou Aier Ophthalmology Hospital,Guangzhou,China,510288[35]Zhejiang University School of Medicine - The Second Affiliated Hospital,Hangzhou,China,310003[36]Hebei eye hospital,Hebei,China,050010[37]Henan Provincial Eye Hospital,Henan,China,450008[38]Jinan Second People''s Hospital,Jinan,China,250021[39]Eye hospital of Shandong First Medical University,Jinan,China,250299[40]People''s Hospital of Ningxia Hui Autonomous Region - Opthalmology,Ningxia,China,750002[41]Shandong University of Traditional Chinese Medicine Affiliated Ophthalmology Hospital,Shandong,China,250299[42]Weifang Ophthalmology Hospital,Shandong,China,261041[43]Shanghai eye disease prevention and control center,Shanghai,China,200041[44]Shanghai General Hospital,Shanghai,China,200080[45]Shanghai Jiao Tong University School of Medicine (SJTUSM) - XinHua Hospital,Shanghai,China,200092[46]Eye & Ent Hospital of Fudan University,Shanghai,China,200126[47]Joint Shantou International Eye Center (JSIEC)Shantou University & the Chinese University of Hong Kong,Shantou,China,515041[48]Shanxi Eye Hospital,Shanxi,China,030002[49]Shenyang He Eye Specialist Hospital,Shenyang,China,110034[50]The Fourth People''s Hospital of Shenyang,Shenyang,China,110082[51]Shijiazhuang People''s Hospital,Shijiazhuang,China,050011[52]Tianjin Medical University Eye Hospital,Tianjin,China,300384[53]Eye Hospital of Wenzhou Medical University,Wenzhou,China,325027[54]Xi''an People''s Hospital (Xi''an Fourth Hospital),Xi''an,China,710005[55]Xianyang First People''s Hospital,Xianyang,China,712099[56]HKU Eye Centre,Hong Kong,Hong Kong,00000[57]Grantham Hospital,Hong Ko
Researchers are looking for a better way to treat people who have diabetic macular edema. Diabetic macular edema (DME) is a diabetes-related eye disorder. In DME, the macula, which is the central part of the retina at the back of the eye, swells up resulting in vision problems. This happens due to leakage of fluid from damaged blood vessels. The study treatment, 8 milligram (mg) aflibercept is injected into the eye. It works by blocking a protein called vascular endothelial growth factor (VEGF) which causes abnormal growth and leakage of blood vessels at the back of the eye. A lower dose of aflibercept (2 mg) is already approved for the treatment of DME. Based on the findings of another study, the higher dose of aflibercept (8 mg) is expected to reduce the frequency of injections required for treating DME while being equally safe and working as well as the lower dose. The higher dose could make it easier to treat DME and improve quality of life for people with DME. The main purpose of this study is to learn if high-dose (8 mg) aflibercept given every 16 weeks works as well as low-dose (2 mg) aflibercept given every 8 weeks in Chinese participants. For this, the researchers will compare the change in participants' 'best corrected visual acuity' (BCVA) after 48 weeks of starting the treatment. BCVA is the clearest vision a participant can have with the help of corrective lenses, such as glasses. It will be measured by the number of letters the participant can read on an eye chart. This is known as their Early Treatment Diabetic Retinopathy Study (ETDRS) letter score. Participants will be randomly (by chance) assigned to one of two treatment groups to receive study treatment as an injection into the eye up to Week 56: - 2 mg aflibercept every 8 weeks after receiving 5 initial monthly doses - 8 mg aflibercept every 16 weeks after receiving 3 initial monthly doses Each participant will be in the study for around 63 weeks with up to 18 visits to the study site. This includes: - one visit up to 21 days before the treatment starts during which the doctors will confirm that the participant can take part in the study - 16 visits during which the treatment will be given. Most of these visits will have a gap of 4 weeks except for one visit that will happen a few days after the previous visit - one visit 4 weeks after the treatment ends During the study, the doctors and their study team will: - check the participants' vision and their overall eye health using different eye tests - check participants' health by performing tests such as blood and urine tests - ask the participants questions about the disease and study treatment and how these impact their quality of life - ask the participants what adverse events they are having An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective of whether they think they are related to the study treatment. Access to study treatment after the end of this study is not planned. Participants can switch to available approved treatments for DME.
