Diabetic Macular Edema (DME)Phase 4NCT07612904
Zhuochuming®-3T&E-DME Study (Treatment-naïve Patients)
A Phase 4 study testing Aflibercept Intravitreous Injection in people with Diabetic Macular Edema (DME), run by The Third Peoples Hospital of Dalian at 1 site in China.
Trial summary
The goal of this clinical trial is to understand whether Zhuochuming® (Aflibercept Intravitreal Injection) using a 3 loading doses followed by a treat-and-extend regimen (3+T\&E) can treat patients with diabetic macular edema (DME) who have not received prior treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema (DME)
- What is being tested?
- Aflibercept Intravitreous Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2026to 31 Jul 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Subject voluntarily participates in the study and signs the informed consent form.
- Subject is aged ≥18 years and has a diagnosis of type 1 or type 2 diabetes mellitus.
- Refractive status and axial length of the study eye: -6.00D < spherical equivalent < +6.00D, or 21 mm < axial length < 26 mm.
- Best-corrected visual acuity (BCVA) of the study eye at screening and baseline is between 78 and 24 ETDRS letters (approximately equivalent to Snellen 20/32 to 20/320).
- Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 3 days before the first dose and must use an acceptable method of contraception.
- Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study requirements.
- The study eye has center-involving diabetic macular edema (DME), defined as central retinal thickness (CRT) ≥300 μm (or ≥320 μm assessed by Heidelberg Spectralis) confirmed by the reading center of the Third People's Hospital of Dalian (primary center) at baseline visit. The reading center is composed of three senior vitreoretinal specialists and experts from the functional examination department of the Third People's Hospital of Dalian.
- Visual impairment is primarily caused by DME.
Who cannot join
- Known hypersensitivity to any component of the study drug.
- Prior intraocular surgery in the study eye, including macular laser photocoagulation, panretinal photocoagulation, etc.
- Prior intraocular or periocular steroid treatment in the study eye.
- Prior intravitreal anti-VEGF therapy (e.g., ranibizumab, conbercept, bevacizumab) in the study eye.
- Prior photodynamic therapy in the study eye.
- Active ocular inflammation (including trace or more) in either eye.
Show all 25Show fewer
- Aphakia or absence of the posterior capsule in the study eye (excluding pseudophakic eyes).
- History of corneal transplantation in the study eye.
- History of idiopathic or autoimmune uveitis in either eye.
- Uncontrolled glaucoma in the study eye (defined as intraocular pressure >25 mmHg despite anti-glaucoma medication) or history of glaucoma filtering surgery.
- Any history of vitreous hemorrhage in the study eye within 4 weeks prior to screening.
- Presence of other retinal diseases in the study eye, such as retinal detachment, retinal vein occlusion, etc.
- Inadequately controlled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥95 mmHg based on average of ≥2 measurements), allowing improvement with antihypertensive treatment; or history of hypertensive crisis or hypertensive encephalopathy.
- Severe cardiovascular disease (myocardial infarction or cerebrovascular accident), unstable arrhythmia, or unstable angina within 3 months prior to the first dose.
- Renal failure requiring dialysis or kidney transplantation.
- Female subjects who are pregnant, breastfeeding, or planning to become pregnant during the study period.
- History of schizophrenia or substance abuse (psychoactive drugs).
- Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) study or the follow-up phase of an interventional study.
- Glycated hemoglobin (HbA1c) level ≥10%, and/or recent signs of uncontrolled diabetes (≥3 episodes of severe hypoglycemia within 3 months before baseline, or hospitalization due to acute hyperglycemia-related complications such as diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar state (HHS), or other emergencies caused by severe hyperglycemia (e.g., dehydration, electrolyte disturbance, altered consciousness); or ≥2 episodes of DKA within 1 year before baseline, or ≥1 episode of DKA within 3 months before baseline).
- Presence of proliferative diabetic retinopathy (PDR) in the study eye.
- Ocular disease in the study eye that may confound interpretation of study results, including choroidal neovascularization (CNV) of any cause (e.g., age-related macular degeneration, ocular histoplasmosis, or pathologic myopia).
- Cataract in the study eye that causes visual impairment, or patients judged by the investigator as likely to undergo cataract surgery during the study period.
- The study eye is aphakic (post-vitrectomy), silicone oil-filled, or gas-filled.
- Best-corrected visual acuity (BCVA) of the non-study eye <19 ETDRS letters (approximately equivalent to Snellen 20/400) at screening and baseline.
- Any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Third Peoples Hospital of Dalian
Dalian, Liaoning, 1160033
SHENG LI, +8618141159143, leoonnet@163.com
About this study
Official title: A Prospective, Randomized Controlled, Open-label, Multicenter Clinical Trial of the Efficacy and Safety of Aflibercept Intravitreal Injection (Zhuochuming®) With a 3-month Loading Phase Followed by Treat-and-extend Regimen in Treatment-naïve Patients With Diabetic Macular Edema
The goal of this clinical trial is to understand whether Zhuochuming® (Aflibercept Intravitreal Injection) using a 3 loading doses followed by a treat-and-extend regimen (3+T\&E) can treat patients with diabetic macular edema (DME) who have not received prior treatment. It will also evaluate the safety of Zhuochuming®.
The main questions it aims to answer are:
Read more
Can Zhuochuming® using the 3+T\&E regimen improve patients' vision better than the traditional pro re nata (3+PRN) regimen?
How much can the macular edema (central retinal thickness) be reduced?
What medical problems (ocular or systemic) will participants experience while taking Zhuochuming®?
What is the difference in the number of injections needed over one year between the two regimens?
Researchers will directly compare Zhuochuming® (3+T\&E regimen) with Zhuochuming® (3+PRN regimen) to see which regimen is more effective and convenient for treating DME.
Participants will:
Receive treatment and be followed for 52 weeks (about 1 year)
First receive 3 injections (one every 4 weeks), and then continue according to their assigned group:
T\&E group: Injection intervals are gradually extended (up to 16 weeks) based on disease stability
PRN group: Follow-up visits every 4 weeks, with injections given only when needed
Visit the clinic at scheduled times (e.g., before each injection or every 4 weeks) for eye examinations (visual acuity, intraocular pressure, OCT, etc.)
Undergo regular blood tests (complete blood count, liver function, coagulation function, HbA1c, etc.)
Record any discomfort or side effects and report them to the doctor
Study population:
Patients with diabetic macular edema (DME) who have not received prior treatment, aged ≥18 years, and diagnosed with type 1 or type 2 diabetes.
Primary study endpoint:
Change in best-corrected visual acuity (BCVA) from baseline at week 52.
- Conditions
- Diabetic Macular Edema (DME)
- Being tested
- Aflibercept Intravitreous Injection
- Keywords
- Prospective, randomized controlled, open-label, multicenter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept Intravitreous InjectionBiological
Experimental：Intravitreal aflibercept 2 mg/0.05 mL (Zhuochuming®), 3 monthly loading doses (W0, W4, W8). From W12: treat-and-extend (T\&E) regimen. Interval extension (by 2-4 weeks, max 16 weeks) if no intraretinal/subretinal fluid on OCT and no worsening criteria. Interval maintenance if fluid persists but decreases. Interval shortening (by 2-4 weeks, min 6 weeks) if new/recurrent fluid, or BCVA loss ≥5 letters with recurrent fluid, or increase in central retinal thickness ≥100 μm.
Active Comparator：Intravitreal aflibercept 2 mg/0.05 mL (Zhuochuming®), 3 monthly loading doses (W0, W4, W8). From W12: pro re nata (PRN) regimen with assessments every 4 weeks. Re-injection criteria: central retinal thickness >250 μm, or increase >50 μm from previous lowest OCT, or loss of ≥5 ETDRS letters in BCVA accompanied by an increase in CRT.
| Study group | Role | What they receive |
|---|---|---|
| 3+T&E Regimen | Experimental | Not described Receives: Biological: Aflibercept Intravitreous Injection |
| 3+PRN Regimen | Active comparator | Not described Receives: Biological: Aflibercept Intravitreous Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the change from baseline in best-corrected visual acuity (BCVA) at week 52 between the experimental group and the control group
Measured: Week52
Secondary outcomes (5)
Compare the change from baseline in OCT-measured central retinal thickness at week 52 between the experimental and control groups
Measured: Week 52
Compare the proportion of patients achieving a ≥15-letter gain in BCVA from baseline at week 52 between the experimental and control groups
Measured: Week 52
Compare the proportion of patients with a <15-letter loss in BCVA from baseline at week 52 between the experimental and control groups
Measured: Week 52
To compare the number of injections within 52 weeks between the experimental group and the control group
Measured: Week 52
To compare the incidence and severity of adverse events (AE) and serious adverse events (SAE) during the treatment period between the experimental group and the control group
Measured: From week 0 to week 52, plus a 30-day safety follow-up after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start30 Jun 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular Edema (DME)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Peoples Hospital of Dalian
- Sponsor type
- University, hospital or other
- Collaborators
- Qilu Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Sheng Li, The Third Peoples Hospital of Dalian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07612904
- Sponsor's protocol ID
- QL-RE1-25002
- Status last verified
- May 2026
- First submitted
- 21 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Controlled, Open-label, Multicenter Clinical Trial of the Efficacy and Safety of Aflibercept Intravitreal Injection (Zhuochuming®) With a 3-month Loading Phase Followed by Treat-and-extend Regimen in Treatment-naïve Patients With Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT07612904
- Acronym / sponsor ID
- QL-RE1-25002
- Conditions
- Diabetic Macular Edema (DME)
- Keywords
- Prospective, randomized controlled, open-label, multicenter
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- The Third Peoples Hospital of DalianUniversity, hospital or other
- Collaborators
- Qilu Pharmaceutical Co., Ltd.
- Study start
- 30 Jun 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to understand whether Zhuochuming® (Aflibercept Intravitreal Injection) using a 3 loading doses followed by a treat-and-extend regimen (3+T\&E) can treat patients with diabetic macular edema (DME) who have not received prior treatment. It will also evaluate the safety of Zhuochuming®.
The main questions it aims to answer are:
Can Zhuochuming® using the 3+T\&E regimen improve patients' vision better than the traditional pro re nata (3+PRN) regimen?
How much can the macular edema (central retinal thickness) be reduced?
What medical problems (ocular or systemic) will participants experience while taking Zhuochuming®?
What is the difference in the number of injections needed over one year between the two regimens?
Researchers will directly compare Zhuochuming® (3+T\&E regimen) with Zhuochuming® (3+PRN regimen) to see which regimen is more effective and convenient for treating DME.
Participants will:
Receive treatment and be followed for 52 weeks (about 1 year)
First receive 3 injections (one every 4 weeks), and then continue according to their assigned group:
T\&E group: Injection intervals are gradually extended (up to 16 weeks) based on disease stability
PRN group: Follow-up visits every 4 weeks, with injections given only when needed
Visit the clinic at scheduled times (e.g., before each injection or every 4 weeks) for eye examinations (visual acuity, intraocular pressure, OCT, etc.)
Undergo regular blood tests (complete blood count, liver function, coagulation function, HbA1c, etc.)
Record any discomfort or side effects and report them to the doctor
Study population:
Patients with diabetic macular edema (DME) who have not received prior treatment, aged ≥18 years, and diagnosed with type 1 or type 2 diabetes.
Primary study endpoint:
Change in best-corrected visual acuity (BCVA) from baseline at week 52.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3+T&E Regimen | Experimental | Biological: Aflibercept Intravitreous Injection |
| 3+PRN Regimen | Active comparator | Biological: Aflibercept Intravitreous Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject voluntarily participates in the study and signs the informed consent form.
- Subject is aged ≥18 years and has a diagnosis of type 1 or type 2 diabetes mellitus.
- Refractive status and axial length of the study eye: -6.00D < spherical equivalent < +6.00D, or 21 mm < axial length < 26 mm.
- Best-corrected visual acuity (BCVA) of the study eye at screening and baseline is between 78 and 24 ETDRS letters (approximately equivalent to Snellen 20/32 to 20/320).
- Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 3 days before the first dose and must use an acceptable method of contraception.
Key exclusion criteria (25 listed)
- Known hypersensitivity to any component of the study drug.
- Prior intraocular surgery in the study eye, including macular laser photocoagulation, panretinal photocoagulation, etc.
- Prior intraocular or periocular steroid treatment in the study eye.
- Prior intravitreal anti-VEGF therapy (e.g., ranibizumab, conbercept, bevacizumab) in the study eye.
- Prior photodynamic therapy in the study eye.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aflibercept Intravitreous InjectionExperimental：Intravitreal aflibercept 2 mg/0.05 mL (Zhuochuming®), 3 monthly loading doses (W0, W4, W8). From W12: treat-and-extend (T\&E) regimen. Interval extension (by 2-4 weeks, max 16 weeks) if no intraretinal/subretinal fluid on OCT and no worsening criteria. Interval maintenance if fluid persists but decreases. Interval shortening (by 2-4 weeks, min 6 weeks) if new/recurrent fluid, or BCVA loss ≥5 letters with recurrent fluid, or increase in central retinal thickness ≥100 μm. Active Comparator：Intravitreal aflibercept 2 mg/0.05 mL (Zhuochuming®), 3 monthly loading doses (W0, W4, W8). From W12: pro re nata (PRN) regimen with assessments every 4 weeks. Re-injection criteria: central retinal thickness >250 μm, or increase >50 μm from previous lowest OCT, or loss of ≥5 ETDRS letters in BCVA accompanied by an increase in CRT. | Biological | 3+PRN Regimen, 3+T&E Regimen |
Primary outcome
To compare the change from baseline in best-corrected visual acuity (BCVA) at week 52 between the experimental group and the control group
Time frame: Week52
5 secondary outcomes
Compare the change from baseline in OCT-measured central retinal thickness at week 52 between the experimental and control groups
Time frame: Week 52
Compare the proportion of patients achieving a ≥15-letter gain in BCVA from baseline at week 52 between the experimental and control groups
Time frame: Week 52
Compare the proportion of patients with a <15-letter loss in BCVA from baseline at week 52 between the experimental and control groups
Time frame: Week 52
To compare the number of injections within 52 weeks between the experimental group and the control group
Time frame: Week 52
To compare the incidence and severity of adverse events (AE) and serious adverse events (SAE) during the treatment period between the experimental group and the control group
Time frame: From week 0 to week 52, plus a 30-day safety follow-up after the last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aflibercept Intravitreous Injection in people with Diabetic Macular Edema (DME), run by The Third Peoples Hospital of Dalian at 1 site in China.
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 8 inclusion and 25 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: opening soon, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the change from baseline in best-corrected visual acuity (BCVA) at week 52 between the experimental group and the control group (time frame: Week52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2026.