do_not_disturb_altRecruitment Complete
Diabetic macular edema
Bayer Identifier:infoA unique number for a trial given by Bayer.
21583
ClinicalTrials.gov Identifier:infoA unique number for a trial given by United States government.
EudraCT Number:infoA unique reference for a trial given by European medical agency.
Not Available
EU CT Number:infoA unique reference for a trial given by European medical agency under EU Clinical Trial Regulation
Not Available
A Study to Learn More About How Well 8 Milligram Aflibercept Works and How Safe it is in Chinese Participants with Diabetic Macular Edema
Trial purpose
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.
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.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal info
333The overall number of participants needed for a trial.
Trial Dates info
May 2024 - March 2026Trial dates are when the trial starts and ends. If they are in the future, then they are estimates and can change before or during a trial.
Phase info
Phase 3A phase is a step in the research of a new treatment.
Could I Receive a placebo info
NoA “placebo” looks like a treatment but usually does not have any real treatment. A placebo is used to make sure the effects of a treatment that are seen in a trial are actually caused by that treatment.
Products info
Aflibercept (BAY86-5321)A “product” can be any kind of drug, medical device, vaccine, or other treatment that is being studied in a trial.
Accepts Healthy Volunteer info
NoA healthy volunteer is a person who takes part in a trial but does not have a disease or condition. Usually, healthy volunteers are in Phase 1 trials.
Where to participate
| Status | Institution | Location |
|---|---|---|
Active, not recruiting | Capital Medical University (CMU) - Beijing Tongren Hospital | Beijing, 100062, China |
Active, not recruiting | Tianjin Medical University Eye Hospital | Tianjin, 300384, China |
Not yet recruiting | ZheJiang Provincial People's Hospital | Zhejiang, 314408, China |
Active, not recruiting | Shanghai Jiao Tong University School of Medicine (SJTUSM) - XinHua Hospital | shanghai, 200092, China |
Active, not recruiting | Shanxi Eye Hospital | Shanxi, 030002, China |
Active, not recruiting | Zhujiang Hospital of Southern Medical University | Guangzhou, 510280, China |
Active, not recruiting | Zhejiang University School of Medicine - The Second Affiliated Hospital | Hangzhou, 310003, China |
Active, not recruiting | Beijing Aier Intech Eye Hospital | Beijing, 100000, China |
Active, not recruiting | The First Affiliated Hospital of Chongqing Medical Universit | Chongqing, 400042, China |
Active, not recruiting | Beijing Friendship Hospital, Capital Medical University | Beijing, 100050, China |
Active, not recruiting | Chengdu University of Traditional Chinese Medicine - Teaching Hospital (Sichuan Province Traditional Chinese Medicine Hospital) | Chengdu, 610072, China |
Active, not recruiting | Luoyang Third People's Hospital | Luoyang, 471002, China |
Active, not recruiting | Renmin Hosp., Wuhan Univ. | Wuhan, 430040, China |
Recruiting | Shandong University of Traditional Chinese Medicine Affiliated Ophthalmology Hospital | Shandong, 250299, China |
Active, not recruiting | Sichuan University West China Hospital | Chengdu, MISSING, China |
Active, not recruiting | Weifang Ophthalmology Hospital | Shandong, 261041, China |
Active, not recruiting | The Second Hospital of Jilin University | Changchun, 130000, China |
Active, not recruiting | Shijiazhuang People's Hospital | Shijiazhuang, 050011, China |
Active, not recruiting | The Fourth People's Hospital of Shenyang | Shenyang, 110082, China |
Active, not recruiting | Guangzhou First People Hospital | Guangzhou, 510180, China |
Active, not recruiting | Affiliated hospital of Nantong university | nantong, 226006, China |
Active, not recruiting | Eye hospital of Shandong First Medical University | Jinan, 250299, China |
Active, not recruiting | Shanxi Bethune Hospital | Taiyuan, 030032, China |
Active, not recruiting | Shanghai eye disease prevention and control center | Shanghai, 200041, China |
Active, not recruiting | Nanjing First Hospital | Nanjing, 210006, China |
Active, not recruiting | People's Hospital of Ningxia Hui Autonomous Region - Opthalmology | Ningxia, 750002, China |
Active, not recruiting | Chengdu Aier Ophthalmology Hospital | Chengdu, 610041, China |
Active, not recruiting | Eye Hospital of Wenzhou Medical University | Wenzhou, 325027, China |
Active, not recruiting | Taizhou Hospital of Zhejiang Province | Taizhou, 317099, China |
Active, not recruiting | The First Hospital of Jilin University | Changchun City, 130061, China |
Active, not recruiting | Guangzhou Aier Ophthalmology Hospital | Guangzhou, 510288, China |
Active, not recruiting | The Second Affiliated Hospital of Nanchang University | Nanchang, 330200, China |
Active, not recruiting | Beijing Hospital | Beijing, 100730, China |
Active, not recruiting | Joint Shantou International Eye Center (JSIEC)Shantou University & the Chinese University of Hong Kong | Shantou, 515041, China |
Active, not recruiting | Jinan Second People's Hospital | Jinan, 250021, China |
Withdrawn | Fujian Medical University - The First Affiliated Hospital | Fuzhou, 350005, China |
Active, not recruiting | Guangdong Provincial Hospital of TCM | Guangzhou,, 510120, China |
Active, not recruiting | The First Affiliated Hospital of NanChang University | Nanchang, 330006, China |
Active, not recruiting | Lanzhou University Second Hospital | Lanzhou, 730030, China |
Active, not recruiting | The Second Hospital of Anhui medical university | Hefei, 230601, China |
Recruiting | The People's Hospital of Guangxi Zhuang Autonomous Region | Nanning, 530021, China |
Active, not recruiting | Zhengzhou Second People's Hospital | erqi, 450015, China |
Active, not recruiting | The First Affiliated Hospital of Harbin Medical University | Harbin, 150001, China |
Active, not recruiting | EYE & ENT HOSPITAL OF FUDAN UNIVERSITY | Shanghai, 200126, China |
Active, not recruiting | Shenyang He Eye Specialist Hospital | Shenyang, 110034, China |
Active, not recruiting | Henan Provincial Eye Hospital | Henan, 450008, China |
Active, not recruiting | Central South University - The Second Xiangya Hospital | Changsha, 410007, China |
Active, not recruiting | Aier Eye Hospital (LIAONING) | Shenyang, N/A, China |
Active, not recruiting | Shanghai General Hospital | Shanghai, 200080, China |
Active, not recruiting | Xianyang First People's Hospital | Xianyang, 712099, China |
Withdrawn | HKU Eye Centre | Hong Kong, 00000, Hong Kong |
Active, not recruiting | Grantham Hospital | Hong Kong, Hong Kong, Hong Kong |
Active, not recruiting | Tseung Kwan O Hospital | Tseung Kwan O, Hong Kong |
Active, not recruiting | Xi'an People's Hospital (Xi'an Fourth Hospital) | Xi'an, 710005, China |
Active, not recruiting | Hebei eye hospital | Hebei, 050010, China |
Withdrawn | Liaocheng People's Hospital | Liaocheng, 252000, China |
Primary OutcomeinfoA primary outcome is the most important effect of a treatment that is measured in a trial. Most trials have one primary outcome measure, but some have more than one.
- Change from baseline in Best corrected visual acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score at Week 48The primary endpoint is the change from baseline in BCVA at Week 48. Efficacy analyses will be conducted using the Full analysis set (FAS). The primary efficacy analysis will be a comparison between 2 comparative arms: HDq16 vs. 2q8. The primary efficacy variable (Change from baseline in BCVA by ETDRS letter score at Week 48) will be analyzed using FAS with an Mixed Model for Repeated Measurements (MMRM) analysis model. The model includes baseline BCVA as a covariate, treatment group, baseline CST category, baseline BCVA category, prior DME treatment, and visit as fixed effects, and interaction terms for treatment by visit and baseline BCVA by visit. A Kenward-Roger approximation will be used for the denominator degrees of freedom.date_rangeTime Frame:Week 0 (Baseline) to Week 48
Secondary OutcomeinfoA secondary outcome is an effect of a treatment that is measured in a trial. A secondary outcome is less important than a primary outcome. But secondary outcomes are still important since they help researchers learn more about the effects of a treatment. Most clinical trials have more than one secondary outcome measure.
- Change from baseline in BCVA by ETDRS letter score at Week 60date_rangeTime Frame:Week 0 (Baseline) to Week 60
- Participants gaining ≥15 letters at Week 48 and Week 60date_rangeTime Frame:Week 48 and Week 60
- Participants achieving an ETDRS letter score of at least 69 (approximate 20/40 Snellen equivalent) at Week 48date_rangeTime Frame:Week 48
- Participants with no Intraretinal fluid (IRF) and/or no Subretinal fluid (SRF) in the center subfield at Week 48date_rangeTime Frame:Week 48
- Change from baseline in central subfield thickness (CST) at Week 48date_rangeTime Frame:Week 0 (Baseline) to Week 48
- Change from baseline in leakage on fluorescein angiography (FA) at Week 48date_rangeTime Frame:Week 0 (Baseline) to Week 48
- Change from baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ) total score at Week 48date_rangeTime Frame:Week 0 (Baseline) to Week 48
- Occurrence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Weeks 48 and 60date_rangeTime Frame:Week 48 to Week 60
- Participants developing a treatment-emergent Anti-drug antibody (ADA) response or Nabs to aflibercept through EOS at Week 60date_rangeTime Frame:Week 60
- Systemic exposure to aflibercept as assessed by plasma concentrations of free, adjusted bound, and total aflibercept from baseline through Week 48date_rangeTime Frame:Week 0 (Baseline) to Week 48
Trial design
Trial Type info
InterventionalDescribes the nature of the clinical study.
Intervention Type info
DrugAn intervention is a drug, medical device, vaccine, or other treatment that is being studied in a trial or is already approved for all patients to use. An intervention can also include treatments like changing diet and exercise, or educating people about a health topic.
Trial Purpose info
TreatmentThe main reason the clinical trial is being done.
Allocation info
RandomizedAllocation is the way treatments are assigned to the people in the trial.
Blinding info
N/A“Blinding” means a person in a trial does not know what treatment they are using. Everyone in the trial knows which treatments they might get if they join the trial, but they do not always know which treatment they use during the trial.
Assignment info
Parallel AssignmentAn “assignment” is the way that people in a trial are assigned to use a treatment.
Trial Arms info
2A “trial arm” is a group of people in a trial. Each trial arm is assigned to use a specific treatment. Types of trial arms are: Experimental arm is a group assigned to use the treatment being studied in the trial Active comparator arm is a group assigned to use a treatment considered to be effective. The results of this group are compared to the results of the experimental arm. Placebo arm is a group assigned to use a placebo. A “placebo” looks like a treatment but usually does not have any real treatment. The results of this group are compared to the experimental arm. This helps make sure any effects that are seen in the experimental arm are actually caused by the main treatment being studied. No intervention arm is a group that is not assigned to use a treatment. The people in this group do not use any treatment during the trial.