AzTrials
AzTrials

Diabetic Macular EdemaPhase 3PHOTONiCNCT06422507

A Study to Learn More About How Well 8 Milligram Aflibercept Works and How Safe it is in Chinese Participants With Diabetic Macular Edema

A Phase 3 study testing 8 mg aflibercept (BAY 86-5321) (High Dose) and 2 mg aflibercept (EYLEA, BAY 86-5321) in people with Diabetic Macular Edema, run by Bayer at 52 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Macular Edema
What is being tested?
8 mg aflibercept (BAY 86-5321) (High Dose) and 2 mg aflibercept (EYLEA, BAY 86-5321)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
333 participants
Where
52 sitesin 2 countries
Study dates
29 May 2024to 25 Mar 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

52 sites in 2 countries.

52 sites in 2 countries

China50 sites

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730

  • Beijing Aier Intech Eye Hospital

    Beijing, 100000

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, 100050

  • Capital Medical University (CMU) - Beijing Tongren Hospital

    Beijing, 100062

  • The Second Hospital of Jilin University

    Changchun, Jilin, 130000

  • The First Hospital of Jilin University

    Changchun, Jilin, 130061

  • Central South University - The Second Xiangya Hospital

    Changsha, 410007

  • Sichuan University West China Hospital

    Chengdu, Sichuan, MISSING

  • Chengdu Aier Ophthalmology Hospital

    Chengdu, 610041

  • Chengdu University of Traditional Chinese Medicine - Teaching Hospital (Sichuan Province Traditional Chinese Medicine Hospital)

    Chengdu, 610072

  • The First Affiliated Hospital of Chongqing Medical Universit

    Chongqing, 400042

  • Zhengzhou Second People's Hospital

    Erqi, Zhengzhou, 450015

  • Guangdong Provincial Hospital of TCM

    Guangzhou, Guangdong, 510120

  • Guangzhou First People Hospital

    Guangzhou, Guangdong, 510180

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510280

  • Guangzhou Aier Ophthalmology Hospital

    Guangzhou, 510288

  • Zhejiang University School of Medicine - The Second Affiliated Hospital

    Hangzhou, 310003

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

  • Hebei eye hospital

    Hebei, 050010

  • The Second Hospital of Anhui medical university

    Hefei, Anhui, 230601

  • Henan Provincial Eye Hospital

    Henan, 450008

  • Jinan Second People's Hospital

    Jinan, 250021

  • Eye hospital of Shandong First Medical University

    Jinan, 250299

  • Lanzhou University Second Hospital

    Lanzhou, Gansu, 730030

  • Luoyang Third People's Hospital

    Luoyang, Henan, 471002

  • The First Affiliated Hospital of NanChang University

    Nanchang, Jiangxi, 330006

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330200

  • Nanjing First Hospital

    Nanjing, Jiangsu, 210006

  • The People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi, 530021

  • Affiliated hospital of Nantong university

    Nantong, Jiangsu, 226006

  • People's Hospital of Ningxia Hui Autonomous Region - Opthalmology

    Ningxia, 750002

  • Shandong University of Traditional Chinese Medicine Affiliated Ophthalmology Hospital

    Shandong, 250299

  • Weifang Ophthalmology Hospital

    Shandong, 261041

  • Shanghai eye disease prevention and control center

    Shanghai, 200041

  • Shanghai General Hospital

    Shanghai, 200080

  • Shanghai Jiao Tong University School of Medicine (SJTUSM) - XinHua Hospital

    Shanghai, 200092

  • Eye & Ent Hospital of Fudan University

    Shanghai, 200126

  • Joint Shantou International Eye Center (JSIEC)Shantou University & the Chinese University of Hong Kong

    Shantou, 515041

  • Shanxi Eye Hospital

    Shanxi, 030002

  • Aier Eye Hospital (LIAONING)

    Shenyang, Liaoning

  • Shenyang He Eye Specialist Hospital

    Shenyang, 110034

  • The Fourth People's Hospital of Shenyang

    Shenyang, 110082

  • Shijiazhuang People's Hospital

    Shijiazhuang, 050011

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, 030032

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang, 317099

  • Tianjin Medical University Eye Hospital

    Tianjin, 300384

  • Eye Hospital of Wenzhou Medical University

    Wenzhou, 325027

  • Renmin Hosp., Wuhan Univ.

    Wuhan, Hubei, 430040

  • Xi'an People's Hospital (Xi'an Fourth Hospital)

    Xi'an, 710005

  • Xianyang First People's Hospital

    Xianyang, 712099

Other trials in China

Hong Kong2 sites

  • Grantham Hospital

    Hong Kong, Hong Kong SAR, 00000

  • Tseung Kwan O Hospital

    Tseung Kwan O, New Territories, 00000

Other trials in Hong Kong

About this study

Official title: 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

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.

Read more

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.

Read the detailed description

EYLEA (aflibercept 40 mg/mL solution for injection) at a dosage level of 2 mg administered intravitreally (IVT) is approved in over 100 countries for the treatment of DME. Despite the proven efficacy and safety of EYLEA in patients with DME, there remains an unmet need for alternative therapies that can decrease the burden of DME treatment via a reduction in the required frequency of IVT injections, while improving visual and anatomic outcomes. The overall one and two year results of PHOTON, a global phase 2/3 trial evaluating high dose (HD or 8 mg) aflibercept in participants with center-involved diabetic macular edema (DME), demonstrate the benefit of HD aflibercept for reducing the frequency of injections required for the treatment of DME while providing visual and anatomic outcomes non-inferior to and a safety profile indistinguishable from EYLEA, 2 mg aflibercept, the established standard of care for the treatment of DME. The observed reduction in the number of HD aflibercept injections required for the treatment of DME over 2 years in PHOTON is expected to translate into the benefit of reducing the burden of treatment and, thereby improving the quality of life for DME patients, their caregivers and health care providers. This study aims to investigate the efficacy and safety of HD aflibercept in Chinese participants with DME over 60 weeks with the primary objective of achieving non-inferior best corrected visual acuity (BCVA) with an extended dosing interval (every 16 weeks after 3 initial monthly injections) vs. 2 mg aflibercept (every 8 weeks after 5 initial monthly injections) similar to the results obtained in PHOTON. This study is designed to support the registration of HD aflibercept for the treatment of DME in China.

Primary Objective: The primary objective of the study is to determine if treatment with HD aflibercept at intervals of 16 weeks provides non-inferior best-corrected visual acuity (BCVA) compared to 2 mg aflibercept dosed every 8 weeks in Chinese participants

Secondary Objectives:

  • To determine the effect of HD aflibercept vs. 2 mg aflibercept on anatomic and other visual measures of response;
  • To evaluate the safety, immunogenicity and pharmacokinetics (PK) of HD aflibercept in Chinese participants.

Primary endpoint:

  • Change from baseline in BCVA by ETDRS letter score at Week 48

Secondary endpoints:

  • Change from baseline in BCVA by ETDRS letter score at Week 60
  • Participants gaining ≥15 letters at Week 48 and Week 60
  • Participants achieving an ETDRS letter score of at least 69 (approximate 20/40 Snellen equivalent) at Week 48
  • Participants with no IRF and/or no SRF in the center subfield at Week 48
  • Change from baseline in central subfield thickness (CST) at Week 48
  • Change from baseline in leakage on fluorescein angiography (FA) at Week 48
  • Change from baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ) total score at Week 48
  • Occurrence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Weeks 48 and 60
  • Participants developing a treatment-emergent ADA response or Nabs to aflibercept through EOS at Week 60
  • Systemic exposure to aflibercept as assessed by plasma concentrations of free, adjusted bound, and total aflibercept from baseline through Week 48 This study is a phase 3, multi-center, randomized, double-masked, active-controlled study in Chinese participants with DME involving the center of the macula to investigate the efficacy and safety of HD aflibercept versus 2 mg aflibercept.

The primary objective of the study is to determine if treatment with HD aflibercept at 16 week intervals provides non-inferior BCVA compared to 2 mg aflibercept dosed every 8 weeks in Chinese participants.

322 eligible participants randomized in a 1:1 ratio to the following 2 treatment groups:

  1. 2q8: 2 mg aflibercept every 8 weeks following 5 initial monthly doses (n=161) and
  2. HDq16: HD aflibercept every 16 weeks following 3 initial monthly doses (n=161). The study consists of a screening period, a treatment period, and an end of study (EOS) visit at Week 60. The study duration for a participant is approximately 63 weeks. The EOS is defined as the last visit of the last participant. No study treatment will be administered at the EOS visit at Week 60.

HD aflibercept is the sponsor's study intervention under investigation. The following intervention groups are included in the study:

  • 2 mg aflibercept every 8 weeks (2q8)
  • 8 mg aflibercept every 16 weeks (HDq16)
Being tested
8 mg aflibercept (BAY 86-5321) (High Dose), 2 mg aflibercept (EYLEA, BAY 86-5321), Sham
Keywords
DME

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 8 mg aflibercept (BAY 86-5321) (High Dose)Drug

    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.

  • 2 mg aflibercept (EYLEA, BAY 86-5321)Drug

    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.

  • ShamOther

    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).

Study groups in NCT06422507
Study groupRoleWhat they receive
2 mg afliberceptActive 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.
Receives: Drug: 2 mg aflibercept (EYLEA, BAY 86-5321); Other: Sham
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.
Receives: Drug: 8 mg aflibercept (BAY 86-5321) (High Dose); Other: Sham

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 0 (Baseline) to Week 48

Secondary outcomes (10)

  1. Change from baseline in BCVA by ETDRS letter score at Week 60

    Measured: Week 0 (Baseline) to Week 60

  2. Participants gaining ≥15 letters at Week 48 and Week 60

    Measured: Week 48 and Week 60

  3. Participants achieving an ETDRS letter score of at least 69 (approximate 20/40 Snellen equivalent) at Week 48

    Measured: Week 48

  4. Participants with no Intraretinal fluid (IRF) and/or no Subretinal fluid (SRF) in the center subfield at Week 48

    Measured: Week 48

  5. Change from baseline in central subfield thickness (CST) at Week 48

    Measured: Week 0 (Baseline) to Week 48

  6. Change from baseline in leakage on fluorescein angiography (FA) at Week 48

    Measured: Week 0 (Baseline) to Week 48

  7. Change from baseline in National Eye Institute Visual Function Questionnaire (NEI-VFQ) total score at Week 48

    Measured: Week 0 (Baseline) to Week 48

  8. Occurrence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Weeks 48 and 60

    Measured: Week 48 to Week 60

  9. Participants developing a treatment-emergent Anti-drug antibody (ADA) response or Nabs to aflibercept through EOS at Week 60

    Measured: Week 60

  10. Systemic exposure to aflibercept as assessed by plasma concentrations of free, adjusted bound, and total aflibercept from baseline through Week 48

    Measured: Week 0 (Baseline) to Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2024
  2. Study start29 May 2024
  3. Primary completion29 Dec 2025
  4. Study completion25 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study duration for a participant is approx 63 weeks. EOS is defined as the last visit of the last participant. HD aflibercept is the sponsor's study intervention under investigation. 322 participants will be randomized into 2 treatment groups in a ratio of 1:1 to receive either 2 mg aflibercept every 8 weeks following 5 initial monthly doses (2q8) or HD aflibercept (8mg) every 16 weeks following 3 initial monthly doses (HDq16). Randomization will be stratified according to baseline Central subfield thickness (CST \<400µm, ≥400µm), baseline BCVA (\<60 vs ≥60 ETDRS letters) and prior treatment for DME. Only 1 eye per participant is identified as the study eye. If a participant's fellow (non-study) eye has DME or Neovascular age-related macular degeneration (nAMD) that requires anti-Vascular endothelial growth factor (VEGF) treatment during the participant's involvement in the study, this eye should be treated with EYLEA (2mg aflibercept) and won't be considered an additional study eye.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
333 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06422507
Sponsor's protocol ID
21583
Acronym
PHOTONiC
Status last verified
Mar 2026
First submitted
15 May 2024
Last updated
31 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 8 mg aflibercept (BAY 86-5321) (High Dose) and 2 mg aflibercept (EYLEA, BAY 86-5321) in people with Diabetic Macular Edema, run by Bayer at 52 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in China, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in Best corrected visual acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score at Week 48 (time frame: Week 0 (Baseline) to Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06422507.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.

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