A Study to Learn More About How Well 8 Milligram Aflibercept Works and How Safe it is in Chinese Participants With Diabetic Macular Edema
PHOTONiC
Multi-Center, Randomized, Double-Masked, Active-Controlled, Phase 3 Study of the Efficacy and Safety of 8 mg Aflibercept in Chinese Participants With Diabetic Macular Edema
1 other identifier
interventional
333
2 countries
52
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2024
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2024
CompletedFirst Posted
Study publicly available on registry
May 21, 2024
CompletedStudy Start
First participant enrolled
May 29, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 29, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2026
CompletedMarch 31, 2026
March 1, 2026
1.6 years
May 15, 2024
March 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in Best corrected visual acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score at Week 48
The 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.
Week 0 (Baseline) to Week 48
Secondary Outcomes (10)
Change from baseline in BCVA by ETDRS letter score at Week 60
Week 0 (Baseline) to Week 60
Participants gaining ≥15 letters at Week 48 and Week 60
Week 48 and Week 60
Participants achieving an ETDRS letter score of at least 69 (approximate 20/40 Snellen equivalent) at Week 48
Week 48
Participants with no Intraretinal fluid (IRF) and/or no Subretinal fluid (SRF) in the center subfield at Week 48
Week 48
Change from baseline in central subfield thickness (CST) at Week 48
Week 0 (Baseline) to Week 48
- +5 more secondary outcomes
Study Arms (2)
2 mg aflibercept
ACTIVE COMPARATORParticipants that will be enrolled to this treatment arm will receive 2 mg aflibercept every 8 weeks following 5 initial monthly doses starting at Baseline (visit 2) (2q8) for the chosen "study eye". Randomization will be stratified according to baseline Central subfield thickness (CST) (\<400 µm, ≥400 µm), baseline Best corrected visual acuity (BCVA) (\<60 vs. ≥60 ETDRS letters) and prior treatment for DME.
8 mg aflibercept (high dose)
EXPERIMENTALParticipants that will be enrolled to this treatment arm will receive 8 mg (high dose - HD) aflibercept every 16 weeks following 3 initial monthly doses, starting at Baseline (Visit 2) (HDq16) for the chosen "study eye". Randomization will be stratified according to baseline Central subfield thickness (CST) (\<400 µm, ≥400 µm), baseline Best corrected visual acuity (BCVA) (\<60 vs. ≥60 ETDRS letters) and prior treatment for DME.
Interventions
High-dose (HD) aflibercept is the sponsor's study intervention under investigation. Dose formulation: solution in vial. Unit dose strength: 114.3 mg/mL, Dosage Level: 8 mg (70 µL), Route of Administration: Intravitreal (IVT) injection every 16 weeks following 3 initial monthly doses. Packaging/ Labeling: Study Intervention will be provided in sterile 3 mL glass vials. Each vial will be labeled as required per country requirement.
Aflibercept 2 mg is the sponsor's active comparator. Dose formulation: solution in vial. Unit dose strength: 40 mg/mL, Dosage Level: 2 mg (50 µL), Route of Administration: Intravitreal (IVT) injection every 8 weeks following 5 initial monthly doses. Packaging/ Labeling: Study Intervention will be provided in sterile 2 mL glass vials. Each vial will be labeled as required per country requirement. Aflibercept 2 mg for the non-study "fellow eye" treatment is considered an auxiliary medicinal product (AxMP) in this study. Fellow eye treatment will be allowed with 2 mg aflibercept, at the investigator's discretion for indications approved by governing authorities. The treated fellow eye will not be considered an additional study eye.
To preserve masking, sham injections will be performed for all participants at treatment visits in which participants do not receive an active injection through Week 56. Sham kits will be assigned for visits requiring sham injections. The sham kits are empty but should be handled in the same way as the active study intervention kits. Sham injections will be given on visits when an active injection is not planned. During the study treatment period all participants will receive either an active injection (8 mg or 2 mg aflibercept) or a sham injection (for masking purposes) following their assigned treatment group and eligibility for Dose regimen modification (DRM).
Eligibility Criteria
You may qualify if:
- Men or women ≥18 years of age
- Chinese participants with type 1 or type 2 diabetes mellitus and diabetic macular edema (DME) with central involvement defined as CST ≥300 µm (or ≥320 µm on Heidelberg Spectralis) in the study eye as determined by the reading center at the screening visit and confirmed by the site at baseline visit
- BCVA early treatment diabetic retinopathy study (ETDRS) letter score of 78 to 24 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye at the screening and baseline visits with decreased vision determined to be primarily the result of DME
- Women of childbearing potential (WOCBP) or men who are sexually active with partners of childbearing potential must agree to use highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 4 months after the last administration of study intervention.
You may not qualify if:
- Evidence of macular edema due to any cause other than diabetes mellitus in either eye
- Active proliferative diabetic retinopathy in the study eye
- Panretinal laser photocoagulation (PRP) or macular laser photocoagulation in the study eye within 12 weeks (84 days) of the screening visit
- IVT anti-VEGF treatment (aflibercept, ranibizumab, bevacizumab, conbercept, faricimab, brolucizumab, pegaptanib sodium) in the study eye within 12 weeks (84 days) of the screening visit
- Previous use of topical steroids within 4 weeks (28 days) of the screening visit or of intraocular or periocular corticosteroids in the study eye within 16 weeks (112 days) of the screening visit, or ILUVIEN or OZURDEX IVT implants at any time
- Prior ocular investigational agents (that have not been approved) in either eye (e.g., IVT, suprachoroidal injections, ocular implants, etc.) at any time.
- Previous treatment with an investigational or approved intraocular gene therapy or cell therapy in either eye at any time.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
- Regeneron Pharmaceuticalscollaborator
Study Sites (52)
The Second Hospital of Anhui medical university
Hefei, Anhui, 230601, China
Beijing Hospital
Beijing, Beijing Municipality, 100730, China
Lanzhou University Second Hospital
Lanzhou, Gansu, 730030, China
Guangdong Provincial Hospital of TCM
Guangzhou, Guangdong, 510120, China
Guangzhou First People Hospital
Guangzhou, Guangdong, 510180, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510280, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530021, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001, China
Luoyang Third People's Hospital
Luoyang, Henan, 471002, China
Renmin Hosp., Wuhan Univ.
Wuhan, Hubei, 430040, China
Nanjing First Hospital
Nanjing, Jiangsu, 210006, China
Affiliated hospital of Nantong university
Nantong, Jiangsu, 226006, China
The First Affiliated Hospital of NanChang University
Nanchang, Jiangxi, 330006, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330200, China
The Second Hospital of Jilin University
Changchun, Jilin, 130000, China
The First Hospital of Jilin University
Changchun, Jilin, 130061, China
Aier Eye Hospital (LIAONING)
Shenyang, Liaoning, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032, China
Sichuan University West China Hospital
Chengdu, Sichuan, MISSING, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, 317099, China
Zhengzhou Second People's Hospital
Erqi, Zhengzhou, 450015, China
Beijing Aier Intech Eye Hospital
Beijing, 100000, China
Beijing Friendship Hospital, Capital Medical University
Beijing, 100050, China
Capital Medical University (CMU) - Beijing Tongren Hospital
Beijing, 100062, China
Central South University - The Second Xiangya Hospital
Changsha, 410007, China
Chengdu Aier Ophthalmology Hospital
Chengdu, 610041, China
Chengdu University of Traditional Chinese Medicine - Teaching Hospital (Sichuan Province Traditional Chinese Medicine Hospital)
Chengdu, 610072, China
The First Affiliated Hospital of Chongqing Medical Universit
Chongqing, 400042, China
Guangzhou Aier Ophthalmology Hospital
Guangzhou, 510288, China
Zhejiang University School of Medicine - The Second Affiliated Hospital
Hangzhou, 310003, China
Hebei eye hospital
Hebei, 050010, China
Henan Provincial Eye Hospital
Henan, 450008, China
Jinan Second People's Hospital
Jinan, 250021, China
Eye hospital of Shandong First Medical University
Jinan, 250299, China
People's Hospital of Ningxia Hui Autonomous Region - Opthalmology
Ningxia, 750002, China
Shandong University of Traditional Chinese Medicine Affiliated Ophthalmology Hospital
Shandong, 250299, China
Weifang Ophthalmology Hospital
Shandong, 261041, China
Shanghai eye disease prevention and control center
Shanghai, 200041, China
Shanghai General Hospital
Shanghai, 200080, China
Shanghai Jiao Tong University School of Medicine (SJTUSM) - XinHua Hospital
Shanghai, 200092, China
Eye & Ent Hospital of Fudan University
Shanghai, 200126, China
Joint Shantou International Eye Center (JSIEC)Shantou University & the Chinese University of Hong Kong
Shantou, 515041, China
Shanxi Eye Hospital
Shanxi, 030002, China
Shenyang He Eye Specialist Hospital
Shenyang, 110034, China
The Fourth People's Hospital of Shenyang
Shenyang, 110082, China
Shijiazhuang People's Hospital
Shijiazhuang, 050011, China
Tianjin Medical University Eye Hospital
Tianjin, 300384, China
Eye Hospital of Wenzhou Medical University
Wenzhou, 325027, China
Xi'an People's Hospital (Xi'an Fourth Hospital)
Xi'an, 710005, China
Xianyang First People's Hospital
Xianyang, 712099, China
Grantham Hospital
Hong Kong, Hong Kong SAR, 00000, Hong Kong
Tseung Kwan O Hospital
Tseung Kwan O, New Territories, 00000, Hong Kong
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- The study will be conducted in double-masked fashion. Study participants and masked study site personnel will remain masked to all randomization assignments throughout the study. The Sponsor personnel who are in regular contact with the study site will remain masked to all participant randomization assignments. The operational conduct of the study after the primary analysis at Week 48 will be maintained by a masked team. No decisions on data will be taken by any of the unmasked study personnel. To preserve masking, sham injections will be performed for all participants at treatment visits in which participants do not receive an active injection through Week 56.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2024
First Posted
May 21, 2024
Study Start
May 29, 2024
Primary Completion
December 29, 2025
Study Completion
March 25, 2026
Last Updated
March 31, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.