do_not_disturb_altRecruitment Complete

Diabetic macular edema

Bayer Identifier:

21583

ClinicalTrials.gov Identifier:

NCT06422507

EudraCT Number:

Not Available

EU CT Number:

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • Key :

    - 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.

    Key
  • - 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.

Trial summary

Enrollment Goal
333
Trial Dates
May 2024 - March 2026
Phase
Phase 3
Could I Receive a placebo
No
Products
Aflibercept (BAY86-5321)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Active, not recruiting
Capital Medical University (CMU) - Beijing Tongren HospitalBeijing, 100062, China
Active, not recruiting
Tianjin Medical University Eye HospitalTianjin, 300384, China
Not yet recruiting
ZheJiang Provincial People's HospitalZhejiang, 314408, China
Active, not recruiting
Shanghai Jiao Tong University School of Medicine (SJTUSM) - XinHua Hospitalshanghai, 200092, China
Active, not recruiting
Shanxi Eye HospitalShanxi, 030002, China
Active, not recruiting
Zhujiang Hospital of Southern Medical UniversityGuangzhou, 510280, China
Active, not recruiting
Zhejiang University School of Medicine - The Second Affiliated HospitalHangzhou, 310003, China
Active, not recruiting
Beijing Aier Intech Eye HospitalBeijing, 100000, China
Active, not recruiting
The First Affiliated Hospital of Chongqing Medical UniversitChongqing, 400042, China
Active, not recruiting
Beijing Friendship Hospital, Capital Medical UniversityBeijing, 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 HospitalLuoyang, 471002, China
Active, not recruiting
Renmin Hosp., Wuhan Univ.Wuhan, 430040, China
Recruiting
Shandong University of Traditional Chinese Medicine Affiliated Ophthalmology HospitalShandong, 250299, China
Active, not recruiting
Sichuan University West China HospitalChengdu, MISSING, China
Active, not recruiting
Weifang Ophthalmology HospitalShandong, 261041, China
Active, not recruiting
The Second Hospital of Jilin UniversityChangchun, 130000, China
Active, not recruiting
Shijiazhuang People's HospitalShijiazhuang, 050011, China
Active, not recruiting
The Fourth People's Hospital of ShenyangShenyang, 110082, China
Active, not recruiting
Guangzhou First People HospitalGuangzhou, 510180, China
Active, not recruiting
Affiliated hospital of Nantong universitynantong, 226006, China
Active, not recruiting
Eye hospital of Shandong First Medical UniversityJinan, 250299, China
Active, not recruiting
Shanxi Bethune HospitalTaiyuan, 030032, China
Active, not recruiting
Shanghai eye disease prevention and control centerShanghai, 200041, China
Active, not recruiting
Nanjing First HospitalNanjing, 210006, China
Active, not recruiting
People's Hospital of Ningxia Hui Autonomous Region - OpthalmologyNingxia, 750002, China
Active, not recruiting
Chengdu Aier Ophthalmology HospitalChengdu, 610041, China
Active, not recruiting
Eye Hospital of Wenzhou Medical UniversityWenzhou, 325027, China
Active, not recruiting
Taizhou Hospital of Zhejiang ProvinceTaizhou, 317099, China
Active, not recruiting
The First Hospital of Jilin UniversityChangchun City, 130061, China
Active, not recruiting
Guangzhou Aier Ophthalmology HospitalGuangzhou, 510288, China
Active, not recruiting
The Second Affiliated Hospital of Nanchang UniversityNanchang, 330200, China
Active, not recruiting
Beijing HospitalBeijing, 100730, China
Active, not recruiting
Joint Shantou International Eye Center (JSIEC)Shantou University & the Chinese University of Hong KongShantou, 515041, China
Active, not recruiting
Jinan Second People's HospitalJinan, 250021, China
Withdrawn
Fujian Medical University - The First Affiliated HospitalFuzhou, 350005, China
Active, not recruiting
Guangdong Provincial Hospital of TCMGuangzhou,, 510120, China
Active, not recruiting
The First Affiliated Hospital of NanChang UniversityNanchang, 330006, China
Active, not recruiting
Lanzhou University Second HospitalLanzhou, 730030, China
Active, not recruiting
The Second Hospital of Anhui medical universityHefei, 230601, China
Recruiting
The People's Hospital of Guangxi Zhuang Autonomous RegionNanning, 530021, China
Active, not recruiting
Zhengzhou Second People's Hospitalerqi, 450015, China
Active, not recruiting
The First Affiliated Hospital of Harbin Medical UniversityHarbin, 150001, China
Active, not recruiting
EYE & ENT HOSPITAL OF FUDAN UNIVERSITYShanghai, 200126, China
Active, not recruiting
Shenyang He Eye Specialist HospitalShenyang, 110034, China
Active, not recruiting
Henan Provincial Eye HospitalHenan, 450008, China
Active, not recruiting
Central South University - The Second Xiangya HospitalChangsha, 410007, China
Active, not recruiting
Aier Eye Hospital (LIAONING)Shenyang, N/A, China
Active, not recruiting
Shanghai General HospitalShanghai, 200080, China
Active, not recruiting
Xianyang First People's HospitalXianyang, 712099, China
Withdrawn
HKU Eye CentreHong Kong, 00000, Hong Kong
Active, not recruiting
Grantham HospitalHong Kong, TBC, Hong Kong
Active, not recruiting
Tseung Kwan O HospitalTseung 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 hospitalHebei, 050010, China
Withdrawn
Liaocheng People's HospitalLiaocheng, 252000, China

Primary Outcome

  • 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.
    date_rangeTime Frame:
    Week 0 (Baseline) to Week 48

Secondary Outcome

  • Change from baseline in BCVA by ETDRS letter score at Week 60
    date_rangeTime Frame:
    Week 0 (Baseline) to Week 60
  • Participants gaining ≥15 letters at Week 48 and Week 60
    date_rangeTime Frame:
    Week 48 and Week 60
  • Participants achieving an ETDRS letter score of at least 69 (approximate 20/40 Snellen equivalent) at Week 48
    date_rangeTime Frame:
    Week 48
  • Participants with no Intraretinal fluid (IRF) and/or no Subretinal fluid (SRF) in the center subfield at Week 48
    date_rangeTime Frame:
    Week 48
  • Change from baseline in central subfield thickness (CST) at Week 48
    date_rangeTime Frame:
    Week 0 (Baseline) to Week 48
  • Change from baseline in leakage on fluorescein angiography (FA) at Week 48
    date_rangeTime Frame:
    Week 0 (Baseline) to Week 48
  • Change from baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ) total score at Week 48
    date_rangeTime Frame:
    Week 0 (Baseline) to Week 48
  • Occurrence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Weeks 48 and 60
    date_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 60
    date_rangeTime Frame:
    Week 60
  • Systemic exposure to aflibercept as assessed by plasma concentrations of free, adjusted bound, and total aflibercept from baseline through Week 48
    date_rangeTime Frame:
    Week 0 (Baseline) to Week 48

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

Click here to find further information and, after study completion, the study results according to Bayer's transparency standards.