Diabetic Macular EdemaPhase 4BESTNCT06498050
Brolucizumab Efficacy and Safety Single-Arm Descriptive Trial in Patients With Persistent Diabetic Macular Edema
A Phase 4 study testing intravitreal injection of Brolucizumab 6 mg in study eye in people with Diabetic Macular Edema, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the efficacy of brolucizumab 6 mg in Chinese patients with persistent diabetic macular edema (DME). It will also learn about the safety of brolucizumab 6 mg. 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?
- intravitreal injection of Brolucizumab 6 mg in study eye
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2024to 10 Jul 2025
- 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
- Signed informed consent had to be obtained prior to participation in the study.
- Patients ≥18 years of age at screening.
- Patients with type 1 or type 2 diabetes mellitus and HbA1c of ≤10% at screening.
- Study Eye: Visual impairment due to DME with: (1) BCVA score between 78 and 23 letters, inclusive, using ETDRS visual acuity testing charts at a starting testing distance of 4 meters (approximate Snellen equivalent of 20/32 to 20/320) at screening and baseline. (2)DME involving the center of the macula, with central subfield retinal thickness (e.g. measured from retinal pigment epithelium (RPE) to the inner limiting membrane (ILM) inclusively) of ≥320 μm on SD-OCT at screening. (Investigator must verify accuracy of OCT scan by ensuring it is centered and of adequate quality) (3) Media clarity, pupillary dilation, and individual cooperation sufficient for adequate OCTs. (4) Diagnosis of DME less than 6 months prior to enrollment. (5) Have at least 3 intravitreal injections of the same anti-VEGF medication (Ranibizumab, Aflibercept, or Conbercept) within the 20 weeks prior to enrollment.
Who cannot join
- Active Proliferative Diabetic Retinopathy in the study eye as per investigator.
- Concomitant conditions or ocular disorders in the study eye at screening or baseline which could, in the opinion of the investigator, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require medical or surgical intervention for the duration of the study (e.g. cataract, vitreous hemorrhage, retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause).
- Any active intraocular or periocular infection or active intraocular inflammation (e.g. infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in study eye at screening or baseline, or any history of intraocular inflammation.
- Presence of amblyopia, amaurosis or ocular disorders with vision <20/200 (35 letters) in the fellow eye at screening or baseline.
- History of idiopathic or autoimmune uveitis in the study eye.
- Any history of intravitreal anti-VEGF treatment in study eye during the 28 days prior to baseline.
Show all 14Show fewer
- Use of fluocinolone acetonide intravitreal implant (Iluvien) in study eye at any time. Prior use of other intraocular or periocular corticosteroids in the study eye is not an exclusion provided at least 6-month wash-out prior to baseline.
- Laser photocoagulation (focal/grid or panretinal) in the study eye during the 3 months prior to baseline.
- History of vitreoretinal surgery in study eye.
- Stroke or myocardial infarction during the 6 month period prior to baseline.
- Any history of renal failure requiring dialysis or kidney transplantation or any history of kidney transplantation.
- Poor blood pressure control（SBP≥180 mmHg or DBP≥100 mmHg）
- Any history of systemic anti-VEGF treatment during the 3 months prior to baseline
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to evaluate the efficacy of brolucizumab 6 mg in Chinese patients with persistent diabetic macular edema (DME). It will also learn about the safety of brolucizumab 6 mg.
The main questions it aims to answer are:
Read more
Does brolucizumab 6 mg reduce central subfield thickness (CST) and improve best-corrected visual acuity (BCVA) of participants? What medical problems do participants have after receiving intravitreal injections of brolucizumab 6 mg? Researchers will compare baseline CST and BCVA to those at each post-baseline visit to see if brolucizumab 6 mg works to treat persistent DME.
Participants will:
Receive brolucizumab 6 mg via intravitreal injections following two treatment patterns:
Treatment Pattern 1: every 6 weeks for 5 injections Treatment Pattern 2: every 6 weeks for 3 injections followed by 1 injection after 12 weeks Visit the clinic 8 times for treatment and assessments over the course of 28 weeks
Read the detailed description
This study is a single-arm, open-label study designed to evaluate the efficacy and safety of intravitreal injections (IVI) of brolucizumab 6 mg in Chinese subjects with persistent diabetic macular edema (DME). The study consists of a 2-week screening phase, followed by a 28-week period from the point of informed consent.
Intervention, assessments and analyses will be performed in Guangdong Provincial People's Hospital. Data from assessments will be extracted from the patients' medical records at the following time points: baseline, Week 1, Week 6, Week 12, Week 16, Week 18, Week 24, and at Week 28.
Safety data will be collected from any time point thoughout the study. Any adverse events identified will be recorded and treated per recommended standard treatment guideline combined with local clinical practice.
- Conditions
- Diabetic Macular Edema
- Being tested
- intravitreal injection of Brolucizumab 6 mg in study eye
- Keywords
- diabetic macular edema, brolucizumab, central subfield thickness, visual acuity, anti-VEGF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravitreal injection of Brolucizumab 6 mg in study eyeDrug
After disinfecting the conjunctival sac and administering a topical anesthetic, an intravitreal injection of Brolucizumab at a dose of 6 mg is given.
| Study group | Role | What they receive |
|---|---|---|
| Brolucizumab 6mg | Experimental | Brolucizumab 6 mg will be given via intravitreal injections following two treatment patterns: Treatment pattern 1: q6w*5; Treatment pattern 2: q6w*3 +q12w*1 Receives: Drug: intravitreal injection of Brolucizumab 6 mg in study eye |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with central subfield thickness (CST) <300 μm assessed by Spectral Domain Optical Coherence Tomography (SD-OCT)
Central subfield thickness (CST) will be measured by Spectral Domain Optical Coherence Tomography (SD-OCT). The measurement of CST refers to the mean retinal thickness of the circular area within 1 mm in diameter that centered on the fovea. SD-OCT images will be captured for the study eye using SD-OCT equipment.
Measured: Baseline, week 28
The proportion of patients with best-corrected visual acuity (BCVA) improvement of ≥5 letters assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing chartstesting charts
Best Corrected Visual Acuity (BCVA) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Eligible participants will be those with a BCVA ETDRS letter score ranging from 78 to 23 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye. The scoring system for visual function ranges from 0 to 100, with higher score indicating better visual function.
Measured: Baseline, week 28
Secondary outcomes (12)
Change in BCVA at each post-baseline visit assessed by ETDRS visual acuity testing charts
Best Corrected Visual Acuity (BCVA) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Eligible participants will be those with a BCVA ETDRS letter score ranging from 78 to 23 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye. The scoring system for visual function ranges from 0 to 100, with higher score indicating better visual function.
Measured: Baseline, week 1, week 6, week 12, week 16, week 18, week 24, week 28
The proportion of patients with gain in BCVA of ≥5, ≥10 and ≥15 letters assessed by ETDRS visual acuity testing charts
Best Corrected Visual Acuity (BCVA) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Eligible participants will be those with a BCVA ETDRS letter score ranging from 78 to 23 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye. The scoring system for visual function ranges from 0 to 100, with higher score indicating better visual function.
Measured: Baseline, week 28
The proportion of patients with loss in BCVA of ≥5, ≥10 and ≥15 letters assessed by ETDRS visual acuity testing charts
Best Corrected Visual Acuity (BCVA) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Eligible participants will be those with a BCVA ETDRS letter score ranging from 78 to 23 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye. The scoring system for visual function ranges from 0 to 100, with higher score indicating better visual function.
Measured: Baseline, week 28
Change in CST from baseline at each post-baseline visit assessed by SD-OCT
Central subfield thickness (CST) will be measured by Spectral Domain Optical Coherence Tomography (SD-OCT). The measurement of CST refers to the mean retinal thickness of the circular area within 1 mm in diameter that centered on the fovea. SD-OCT images will be captured for the study eye using SD-OCT equipment.
Measured: Baseline, week 1, week 6, week 12, week 16, week 18, week 24, week 28
The proportion of patients with CST <280 μm assessed by SD-OCT at each post-baseline visit
Central subfield thickness (CST) will be measured by Spectral Domain Optical Coherence Tomography (SD-OCT). The measurement of CST refers to the mean retinal thickness of the circular area within 1 mm in diameter that centered on the fovea. SD-OCT images will be captured for the study eye using SD-OCT equipment.
Measured: Baseline, week 1, week 6, week 12, week 16, week 18, week 24, week 28
The proportion of patients with presence of subretinal fluid (SRF), intraretinal fluid (IRF) and simultaneous absence of SRF and IRF at each post-baseline visit assessed by SD-OCT
Subretinal Fluid (SRF) and Intraretinal Fluid (IRF) will be evaluated in images captured for the study eye using SD-OCT equipment.
Measured: Baseline, week 1, week 6, week 12, week 16, week 18, week 24, week 28
Change in SRF and IRF from baseline assessed by quantitative criteria based on SD-OCT
The volume of SRF and IRF will be calculated in SD-OCT images using artificial intelligence algorithms.
Measured: Baseline, week 28
Change in vessel densities of deep capillary plexus (DCP), superficial capillary plexus (SCP) and radial peripapillary capillaries (RPC), and foveal avascular zone (FAZ) area from baseline based on optical coherence tomography angiography (OCTA)
Optical coherence tomography-angiography (OCT-A) is a dye-less and non-invasive angiographic technique that offers a three-dimension imaging of the retinal circulation. It enables visualizing the movement of particles within blood vessels, predominantly red blood cells, across the entire retinal and choroidal vascular layers.
Measured: Baseline, week 28
The proportion of patients with a ≥2- and ≥3-step improvement or worsening from baseline assessed by the ETDRS Diabetic Retinopathy Severity Scale (DRSS) score
The Early Treatment Diabetic Retinopathy Study Diabetic Retinopathy Severity Scale (DRSS) is a standard approach to measure diabetic retinopathy (DR) severity. Wide-field fundus color photography images were obtained and assessed in the study eye by fundus color photography machines.
Measured: Baseline, week 28
The proportion of patients with presence of leakage assessed by qualitative and quantitative criteria based on ultrawide-field fluorescein angiography (UWFFA)
Fluorescein Angiography (FA) is an invasive eye examination that uses an injected dye to illuminate the retinal and choroidal blood vessels, offering a dynamic, real-time assessment of blood flow and leakage
Measured: Baseline, week 28
The proportions of patients treated with 4 and 5 injections
There are 2 treatment patterns depending on the disease activity assessment at week 18. Treatment Pattern 1: every 6 weeks for 5 injections; Treatment Pattern 2: every 6 weeks for 3 injections followed by 1 injection after 12 weeks.
Measured: Baseline, week 28
Incidence and characteristics of ocular and non-ocular adverse events
An adverse event is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings, symptom or disease) in a clinical investigation The ocular adverse events will be assessed by slip-lamp examination, intraocular pressure from non-contact tonometry, and retinal circulation from optical coherence tomography angiography. The non-ocular adverse events will be assessed by vital signs, complete blood count, biochemical profile, glycosylated hemoglobin A1c, urinary albumin to creatinine ratio, serum pregnancy test, and urine pregnancy test.
Measured: Baseline, week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start10 Jul 2024
- Primary completion10 Jul 2025 (estimated)
- Study completion10 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Novartis Pharma
- Responsible party
- Sponsor
- Investigators
- Honghua Yu, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498050
- Sponsor's protocol ID
- CRTH258BCN03T
- Acronym
- BEST
- Status last verified
- Feb 2025
- First submitted
- 10 Jun 2024
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang Z, Hu Y, Shen C, Li J, Liang A, Fang Y, Zeng J, Liao H, Zheng C, Ouyang S, Hu Y, Cao D, Yu H. Brolucizumab efficacy and safety single-arm descriptive trial in patients with persistent diabetic macular edema (BEST study): protocol for a single-centre, open-label, single-arm clinical trial in China. BMJ Open. 2025 Jul 28;15(7):e099551. doi: 10.1136/bmjopen-2025-099551.
PubMed 40721260
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brolucizumab Efficacy and Safety Single-Arm Descriptive Trial in Patients With Persistent Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT06498050
- Acronym / sponsor ID
- BEST / CRTH258BCN03T
- Conditions
- Diabetic Macular Edema
- Keywords
- diabetic macular edema, brolucizumab, central subfield thickness, visual acuity, anti-VEGF
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Collaborators
- Beijing Novartis Pharma
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 10 Jul 2025 (estimated)
- Study completion
- 10 Jul 2025 (estimated)
- First posted
- 12 Jul 2024 (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 evaluate the efficacy of brolucizumab 6 mg in Chinese patients with persistent diabetic macular edema (DME). It will also learn about the safety of brolucizumab 6 mg.
The main questions it aims to answer are:
Does brolucizumab 6 mg reduce central subfield thickness (CST) and improve best-corrected visual acuity (BCVA) of participants? What medical problems do participants have after receiving intravitreal injections of brolucizumab 6 mg? Researchers will compare baseline CST and BCVA to those at each post-baseline visit to see if brolucizumab 6 mg works to treat persistent DME.
Participants will:
Receive brolucizumab 6 mg via intravitreal injections following two treatment patterns:
Treatment Pattern 1: every 6 weeks for 5 injections Treatment Pattern 2: every 6 weeks for 3 injections followed by 1 injection after 12 weeks Visit the clinic 8 times for treatment and assessments over the course of 28 weeks
Detailed description
This study is a single-arm, open-label study designed to evaluate the efficacy and safety of intravitreal injections (IVI) of brolucizumab 6 mg in Chinese subjects with persistent diabetic macular edema (DME). The study consists of a 2-week screening phase, followed by a 28-week period from the point of informed consent.
Intervention, assessments and analyses will be performed in Guangdong Provincial People's Hospital. Data from assessments will be extracted from the patients' medical records at the following time points: baseline, Week 1, Week 6, Week 12, Week 16, Week 18, Week 24, and at Week 28.
Safety data will be collected from any time point thoughout the study. Any adverse events identified will be recorded and treated per recommended standard treatment guideline combined with local clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brolucizumab 6mg | Experimental | Drug: intravitreal injection of Brolucizumab 6 mg in study eyeBrolucizumab 6 mg will be given via intravitreal injections following two treatment patterns: Treatment pattern 1: q6w*5; Treatment pattern 2: q6w*3 +q12w*1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent had to be obtained prior to participation in the study.
- Patients ≥18 years of age at screening.
- Patients with type 1 or type 2 diabetes mellitus and HbA1c of ≤10% at screening.
- Study Eye: Visual impairment due to DME with: (1) BCVA score between 78 and 23 letters, inclusive, using ETDRS visual acuity testing charts at a starting testing distance of 4 meters (approximate Snellen equivalent of 20/32 to 20/320) at screening and baseline. (2)DME involving the center of the macula, with central subfield retinal thickness (e.g. measured from retinal pigment epithelium (RPE) to the inner limiting membrane (ILM) inclusively) of ≥320 μm on SD-OCT at screening. (Investigator must verify accuracy of OCT scan by ensuring it is centered and of adequate quality) (3) Media clarity, pupillary dilation, and individual cooperation sufficient for adequate OCTs. (4) Diagnosis of DME less than 6 months prior to enrollment. (5) Have at least 3 intravitreal injections of the same anti-VEGF medication (Ranibizumab, Aflibercept, or Conbercept) within the 20 weeks prior to enrollment.
Key exclusion criteria (14 listed)
- Active Proliferative Diabetic Retinopathy in the study eye as per investigator.
- Concomitant conditions or ocular disorders in the study eye at screening or baseline which could, in the opinion of the investigator, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require medical or surgical intervention for the duration of the study (e.g. cataract, vitreous hemorrhage, retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause).
- Any active intraocular or periocular infection or active intraocular inflammation (e.g. infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis, uveitis) in study eye at screening or baseline, or any history of intraocular inflammation.
- Presence of amblyopia, amaurosis or ocular disorders with vision <20/200 (35 letters) in the fellow eye at screening or baseline.
- History of idiopathic or autoimmune uveitis 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 |
|---|---|---|
| intravitreal injection of Brolucizumab 6 mg in study eyeAfter disinfecting the conjunctival sac and administering a topical anesthetic, an intravitreal injection of Brolucizumab at a dose of 6 mg is given. | Drug | Brolucizumab 6mg |
Primary outcome
The proportion of patients with central subfield thickness (CST) <300 μm assessed by Spectral Domain Optical Coherence Tomography (SD-OCT)
Time frame: Baseline, week 28
Central subfield thickness (CST) will be measured by Spectral Domain Optical Coherence Tomography (SD-OCT). The measurement of CST refers to the mean retinal thickness of the circular area within 1 mm in diameter that centered on the fovea. SD-OCT images will be captured for the study eye using SD-OCT equipment.
The proportion of patients with best-corrected visual acuity (BCVA) improvement of ≥5 letters assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing chartstesting charts
Time frame: Baseline, week 28
Best Corrected Visual Acuity (BCVA) was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Eligible participants will be those with a BCVA ETDRS letter score ranging from 78 to 23 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye. The scoring system for visual function ranges from 0 to 100, with higher score indicating better visual function.
12 secondary outcomes
Change in BCVA at each post-baseline visit assessed by ETDRS visual acuity testing charts
Time frame: Baseline, week 1, week 6, week 12, week 16, week 18, week 24, week 28
The proportion of patients with gain in BCVA of ≥5, ≥10 and ≥15 letters assessed by ETDRS visual acuity testing charts
Time frame: Baseline, week 28
The proportion of patients with loss in BCVA of ≥5, ≥10 and ≥15 letters assessed by ETDRS visual acuity testing charts
Time frame: Baseline, week 28
Change in CST from baseline at each post-baseline visit assessed by SD-OCT
Time frame: Baseline, week 1, week 6, week 12, week 16, week 18, week 24, week 28
The proportion of patients with CST <280 μm assessed by SD-OCT at each post-baseline visit
Time frame: Baseline, week 1, week 6, week 12, week 16, week 18, week 24, week 28
The proportion of patients with presence of subretinal fluid (SRF), intraretinal fluid (IRF) and simultaneous absence of SRF and IRF at each post-baseline visit assessed by SD-OCT
Time frame: Baseline, week 1, week 6, week 12, week 16, week 18, week 24, week 28
Change in SRF and IRF from baseline assessed by quantitative criteria based on SD-OCT
Time frame: Baseline, week 28
Change in vessel densities of deep capillary plexus (DCP), superficial capillary plexus (SCP) and radial peripapillary capillaries (RPC), and foveal avascular zone (FAZ) area from baseline based on optical coherence tomography angiography (OCTA)
Time frame: Baseline, week 28
The proportion of patients with a ≥2- and ≥3-step improvement or worsening from baseline assessed by the ETDRS Diabetic Retinopathy Severity Scale (DRSS) score
Time frame: Baseline, week 28
The proportion of patients with presence of leakage assessed by qualitative and quantitative criteria based on ultrawide-field fluorescein angiography (UWFFA)
Time frame: Baseline, week 28
The proportions of patients treated with 4 and 5 injections
Time frame: Baseline, week 28
Incidence and characteristics of ocular and non-ocular adverse events
Time frame: Baseline, week 28
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 4 Jun 2025.
- Derived from this study: PubMed 40721260Huang Z, Hu Y, Shen C, Li J, Liang A, Fang Y, Zeng J, Liao H, Zheng C, Ouyang S, Hu Y, Cao D, Yu H. Brolucizumab efficacy and safety single-arm descriptive trial in patients with persistent diabetic macular edema (BEST study): protocol for a single-centre, open-label, single-arm clinical trial in China. BMJ Open. 2025 Jul 28;15(7):e099551. doi: 10.1136/bmjopen-2025-099551.
- 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. This study is not recruiting at the moment.
Honghua Yu principal investigator
Guangdong Provincial People's Hospital
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 intravitreal injection of Brolucizumab 6 mg in study eye in people with Diabetic Macular Edema, run by Guangdong Provincial People's Hospital 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 4 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2025. 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?
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?
The proportion of patients with central subfield thickness (CST) <300 μm assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) (time frame: Baseline, week 28). The study lists 2 primary outcomes in all. 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 NCT06498050, which also lists 1 linked publication.
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 4 Jun 2025.