Polypoidal Choroidal Vasculopathy (PCV)Phase 4NCT07365371
A Prospective, Multicenter, Open-label, Randomized Clinical Trial to Evaluate the Efficacy, Durability, and Safety of Aflibercept 8mg in Different Treatment Regimens in Chinese Patients With Polypoidal Choroidal Vasculopathy (PCV)
A Phase 4 study testing Aflibercept Intravitreous Injection in people with Polypoidal Choroidal Vasculopathy (PCV) and Neovascular Age Related Macular Degeneration (AMD), run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 20 sites in China.
Trial summary
The goal of this clinical trial is to investigate the efficacy, durability, and safety of aflibercept 8 mg in treating Polypoidal Choroidal Vasculopathy (PCV) in Chinese naive patients. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Polypoidal Choroidal Vasculopathy (PCV), Neovascular Age Related Macular Degeneration (AMD)
- 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
- 174 participants
- Where
- 20 sitesChina
- Study dates
- 1 Jan 2026to 31 Dec 2027
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who fully understand the content, process, and possible AE of the study and capable of giving written informed consent form.
- Male or female, age ≥ 50 years, at the time of signing the informed consent form.
- Women of childbearing potential (WOCBP) must agree to practice a double method of contraception of a medically acceptable method of contraception with an annual failure rate of less than 1% (see Appendix 1) with a barrier contraceptive (such as condom) during the study and for 4 months after discontinuation of study treatment. Women are considered not of childbearing potential if they are surgically sterile (i.e., hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or > 1 year postmenopausal. WOCBP must have negative results of pregnancy test at screening and must not be pregnant, breast feeding, lactating, or planning to become pregnant, breast feed or donate ova during the study and for 4 months after discontinuation of study treatment.
- All male participants with female partners of childbearing potential must agree to practice a double method of contraception of a medically acceptable method of contraception with an annual failure rate of less than 1% (see Appendix 1) with a barrier contraceptive (such as condom), and must agree to abstain from sperm donation during and for 4 months after participation in the study.
- Ocular Inclusion Criteria for Study Eye: Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis.
- Ocular Inclusion Criteria for Study Eye: Confirmed diagnosis, by the investigator, of symptomatic macular PCV defined by the following: a. Active macular polypoidal lesions shown by ICGA, AND presence of CNV involving the macula area within the 6.0 mm ETDRS zone as identified by the investigator using multimodal images. b. BCVA scores of 78~24 ETDRS letters, inclusive (20/32 to 20/320 approximate Snellen equivalent), using the ETDRS protocol and assessed at the initial testing distance of 4 meters on study Day 1 Note: If both eyes meet the inclusion criteria, the eye with the worst visual acuity (VA) at the screening visit will be designated as the study eye. If both eyes have the same VA, the Investigator and patient will determine the study eye.
Who cannot join
- Treatment with investigational therapy (anti-VEGF, corticosteroid, laser photocoagulation, panretinal or macular, and PDT) or approved medications for PCV treatment prior to initiation of study treatment on study Day 1.
- Allergy or hypersensitivity to any of the compounds/excipients in the study interventions formulations.
- Uncontrolled blood pressure (defined as systolic >160 mmHg or diastolic >95 mmHg). Participants may be treated with up to 3 agents known to have anti-hypertensive effects for arterial hypertension to achieve adequate blood pressure control. This limit applies to drugs that could be used to treat hypertension even if their primary indication in the participant was not for blood pressure control. Any recent changes in medications known to affect blood pressure need to be stable for 12 weeks prior to screening.
- History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, might affect interpretation of the results of the study, or renders the participant at high risk for treatment complications.
- Any other conditions that the Investigator considers may affect the patients' informed consent or adherence to the study protocol, completion of the test according to the study procedure, or the patients' participation in the test may affect the test results or their own safety.
- Pregnant or breastfeeding.
Show all 10Show fewer
- Ocular Exclusion Criteria for Study Eye: Any history or presence of macular pathology unrelated to PCV affecting vision or contributing to the presence of macular hemorrhage, IRF, or SRF.
- Ocular Exclusion Criteria for Study Eye: Retinal pigment epithelial tear involving the macula on study Day 1.
- Ocular Exclusion Criteria for Study Eye: On FA/ fundus photograph (FP): a. Subretinal hemorrhage of >4 macular photocoagulation study disc area and/or that involves the fovea b. Fibrosis or atrophy of >50% of the total lesion area and/or that involves the fovea
- Ocular Exclusion Criteria for Study Eye: Any concurrent intraocular condition (e.g., amblyopia, aphakia, retinal detachment, cataract, DR or maculopathy, or epiretinal membrane with traction) that, in the opinion of the investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the study a. Current vitreous hemorrhage on study Day 1 b. Uncontrolled glaucoma c. Any cataract surgery or treatment for complications of cataract surgery with steroids or YAG laser capsulotomy within 3 months prior to study Day 1 d. Any other intraocular surgery (e.g., pars plana vitrectomy, glaucoma surgery, corneal transplant, or radiotherapy) e. Prior periocular pharmacological or IVT treatment (including anti-VEGF medication) for other retinal diseases • Evidence of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye within 4 weeks of the screening visit f. Any intraocular inflammation/infection in either eye within 12 weeks of the screening visit g. History of idiopathic or autoimmune uveitis in the study eye.
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
China20 sites
Beijing Hospital
Beijing, Beijing Municipality
Hong Dai, +86-13910280398, dai-hong@x263.net
Beijing Tongren Hospital, CMU
Beijing, Beijing Municipality
Zhaoyang Wang, +86-15921108602, zhaokekewzy@hotmail.com
The Second People's Hospital Of Foshan
Foshan, Guangdong
Xiangbin Kong, +86-13929994766, xiangbin_kong@sina.com
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Zhiqing Chen, +86-13588069151, 626619258@qq.com
The First Affiliated Hospital Of Harbin Medical University
Harbin, Heilongjiang
Hong Zhang, +86-13804505456, 13804505456@163.com
Jiaxing Hospital of T.C.M
Jiaxing, Zhejiang
Lijun Jiang, +86-13567331008, Eye200@163.com
The Second Norman Bethune Hospital Of Jilin University
Jilin City, Jilin
Jun Xiao, +86-13069247911, xiaoj@jlu.edu.cn
Shandong Provincial Hospital
Jinan, Shandong
Han Zhang, +86-13705310696, zhanghan0696@139.com
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunan
Ling Yuan, +86-13808727321, yuanling8061@163.com
Affiliated Eye Hospital of Nanchang University
Nanchang, Jiangxi
Zhipeng You, +86-13970032654, yzp74@sina.com
Jiangsu Province Hospital , The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu
Weiwei Zhang, +86-15996356000, 15996356000@139.com
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality
Wei Liu, +86-13916679479, bfgf14@aliyun.com
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Shanxi Eye Hospital
Taiyuan, Shanxi
Guohong Zhou, +86-15834030980, guohongzhou2005@163.com
Tianjin Eye Hospital
Tianjin, Tianjin Municipality
Mei Han, +86-13114977372, hanmay69@sina.com
Affiliated Hospital Of Shandong Second Medical University
Weifang, Shandong
Aijun Deng, +86-15966077166, dengaijun@hotmail.com
Renmin Hospital Of Wuhan University
Wuhan, Hubei
Xuan Xiao, +86-15327218573, xiaoxuan1111@whu.edu.cn
Xi' AN No.1 Hospital
Xi'an, Shaanxi
Huiqin Lu, +86-13389255280, 13389255280@163.com
The First People's Hospital Of Xianyang
Xianyang, Shaanxi
Min Wang, +86-15191068813, angin2001@126.com
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Liping Du, +86-13838191481, dulplab@foxmail.com
About this study
The goal of this clinical trial is to investigate the efficacy, durability, and safety of aflibercept 8 mg in treating Polypoidal Choroidal Vasculopathy (PCV) in Chinese naive patients. The main questions it aims to answer are:
- What is the change in Best Corrected Visual Acuity (BCVA) at Week 52 from baseline in different treatment regimens?
- What proportion of patients achieve sustained disease control after receiving the loading dose?
Read more
Participants will:
- Receive intravitreal aflibercept 8 mg loading doses (3 initial monthly doses).
- In Arm A:
- Undergo reinjections based on disease activity, with follow-up examinations every 4 weeks until week 48.
- Return for an end-of-study visit at week 52.
- In Arm B:
- Undergo an examination at week 12 and subsequent treatments based on disease activity, with a maximum interval of 20 weeks and a minimum interval of 8 weeks between doses if the disease remains inactive.
- Return for an end-of-study visit at week 52.
This study will assess the efficacy, safety and durability of aflibercept 8mg in these 2 regimens.
- Conditions
- Polypoidal Choroidal Vasculopathy (PCV), Neovascular Age Related Macular Degeneration (AMD)
- Being tested
- Aflibercept Intravitreous Injection
- Keywords
- Polypoidal Choroidal Vasculopathy (PCV), Neovascular age related macular degeneration (AMD), Aflibercept 8mg
- Medical subject headings
- Polypoidal Choroidal Vasculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept Intravitreous InjectionDrug
Patients will be given IVT injection(s) of IMP using standard injection techniques.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Other | All enrolled patients meeting eligibility will receive intravitreal aflibercept 8 mg loading doses (3 initial monthly doses). Subsequent reinjections will be given according to the changes in patients' disease activity. If no retreatment criteria are met, no additional injections will be given, and patients will undergo follow-up examinations (including ETDRS visual acuity, findus photography, OCT-A and SD-OCT) every 4 weeks until week 48. Patients will return to the Clinical Research Unit (CRU) for an end-of-study (EOS) visit at week 52. Receives: Drug: Aflibercept Intravitreous Injection |
| Arm B | Other | All enrolled patients meeting eligibility will receive intravitreal aflibercept 8 mg loading doses (3 initial monthly doses). All patients in this group will undergo an examination at week 12, including ETDRS visual acuity, fundus photography, OCT-A and SD-OCT. Subsequent treatment regime will depend on disease activity. If disease is considered inactive, the next dose will occur at week 16 (8 week interval from last dose at week 8) and subsequent dose and visit will be extended by 4 weeks up to a maximum interval of 20 weeks and minimum interval of 8 weeks between treatments if disease remains quiescent. If signs of activity are noted at any visit point, visit interval will be reduced by 4 weeks. The last dose will be administered no later than week 48. Patients will return to the CRU for an EOS visit at week 52. Receives: Drug: Aflibercept Intravitreous Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Visual Acuity (BCVA) change at Week 52 after baseline in different treatment regimens.
BCVA (study eye and the fellow eye) examination
Measured: up to 52 Weeks
Secondary outcomes (10)
Percentage of patients gaining >15, >10, or ≥5 letters in BCVA after baseline
BCVA (study eye and the fellow eye) examination
Measured: up to 52 Weeks
Percentage of patients achieving complete polypoidal lesion regression at Weeks 52
SD-OCT Spectral Domain Optical Coherence Tomography, FA Fluorescein Angiography, ICGA Indocyanine Green Angiography, OCT-A Optical Coherence Tomography Angiography, FP Fundus Photography examinations
Measured: up to 52 Weeks
Percentage of patients with no active polypoidal lesion at Week 52
SD-OCT Spectral Domain Optical Coherence Tomography, FA Fluorescein Angiography, ICGA Indocyanine Green Angiography, OCT-A Optical Coherence Tomography Angiography, FP Fundus Photography examinations
Measured: up to 52 Weeks
Change from baseline in central subfield thickness (CST) at Week 12 and 52.
SD-OCT Spectral Domain Optical Coherence Tomography examination
Measured: up to 12 and 52 Weeks
BCVA change from baseline at Week 12
BCVA (study eye and the fellow eye) examination
Measured: up to 12 Weeks
Percentage of patients achieving Q8W, Q12W, and Q16W treatment intervals at Week 52 in Arm B.
Calculating the ratio
Measured: up to 52 Weeks
Percentage of patients achieving Q20W of last assigned interval at Week 52 in Arm B.
Calculating the ratio
Measured: up to 52 Weeks
Percentage of patients achieving ≥12-week, ≥16-week and ≥20-week treatment intervals after completing loading doses in Arm A.
Calculating the ratio
Measured: up to 52 Weeks
Total number of intravitreal injections administered through Week 52 in both arms.
Counting
Measured: up to 52 Weeks
Incidence and severity of ocular & non-ocular adverse events.
Recording of adverse events
Measured: up to 52 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polypoidal Choroidal Vasculopathy (PCV)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
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Principal investigator, Xiaodong Sun, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07365371
- Sponsor's protocol ID
- 23106
- Status last verified
- Jan 2026
- First submitted
- 9 Dec 2025
- Last updated
- 26 Jan 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 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Open-label, Randomized Clinical Trial to Evaluate the Efficacy, Durability, and Safety of Aflibercept 8mg in Different Treatment Regimens in Chinese Patients With Polypoidal Choroidal Vasculopathy (PCV)
- ClinicalTrials.gov ID
- NCT07365371
- Acronym / sponsor ID
- 23106
- Conditions
- Polypoidal Choroidal Vasculopathy (PCV), Neovascular Age Related Macular Degeneration (AMD)
- Keywords
- Polypoidal Choroidal Vasculopathy (PCV), Neovascular age related macular degeneration (AMD), Aflibercept 8mg
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Jan 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 investigate the efficacy, durability, and safety of aflibercept 8 mg in treating Polypoidal Choroidal Vasculopathy (PCV) in Chinese naive patients. The main questions it aims to answer are:
- What is the change in Best Corrected Visual Acuity (BCVA) at Week 52 from baseline in different treatment regimens?
- What proportion of patients achieve sustained disease control after receiving the loading dose?
Participants will:
- Receive intravitreal aflibercept 8 mg loading doses (3 initial monthly doses).
- In Arm A:
- Undergo reinjections based on disease activity, with follow-up examinations every 4 weeks until week 48.
- Return for an end-of-study visit at week 52.
- In Arm B:
- Undergo an examination at week 12 and subsequent treatments based on disease activity, with a maximum interval of 20 weeks and a minimum interval of 8 weeks between doses if the disease remains inactive.
- Return for an end-of-study visit at week 52.
This study will assess the efficacy, safety and durability of aflibercept 8mg in these 2 regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Other | Drug: Aflibercept Intravitreous InjectionAll enrolled patients meeting eligibility will receive intravitreal aflibercept 8 mg loading doses (3 initial monthly doses). Subsequent reinjections will be given according to the changes in patients' disease activity. If no retreatment criteria are met, no additional injections will be given, and patients will undergo follow-up examinations (including ETDRS visual acuity, findus photography, OCT-A and SD-OCT) every 4 weeks until week 48. Patients will return to the Clinical Research Unit (CRU) for an end-of-study (EOS) visit at week 52. |
| Arm B | Other | Drug: Aflibercept Intravitreous InjectionAll enrolled patients meeting eligibility will receive intravitreal aflibercept 8 mg loading doses (3 initial monthly doses). All patients in this group will undergo an examination at week 12, including ETDRS visual acuity, fundus photography, OCT-A and SD-OCT. Subsequent treatment regime will depend on disease activity. If disease is considered inactive, the next dose will occur at week 16 (8 week interval from last dose at week 8) and subsequent dose and visit will be extended by 4 weeks up to a maximum interval of 20 weeks and minimum interval of 8 weeks between treatments if disease remains quiescent. If signs of activity are noted at any visit point, visit interval will be reduced by 4 weeks. The last dose will be administered no later than week 48. Patients will return to the CRU for an EOS visit at week 52. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who fully understand the content, process, and possible AE of the study and capable of giving written informed consent form.
- Male or female, age ≥ 50 years, at the time of signing the informed consent form.
- Women of childbearing potential (WOCBP) must agree to practice a double method of contraception of a medically acceptable method of contraception with an annual failure rate of less than 1% (see Appendix 1) with a barrier contraceptive (such as condom) during the study and for 4 months after discontinuation of study treatment. Women are considered not of childbearing potential if they are surgically sterile (i.e., hysterectomy, bilateral oophorectomy, or bilateral salpingectomy) or > 1 year postmenopausal. WOCBP must have negative results of pregnancy test at screening and must not be pregnant, breast feeding, lactating, or planning to become pregnant, breast feed or donate ova during the study and for 4 months after discontinuation of study treatment.
- All male participants with female partners of childbearing potential must agree to practice a double method of contraception of a medically acceptable method of contraception with an annual failure rate of less than 1% (see Appendix 1) with a barrier contraceptive (such as condom), and must agree to abstain from sperm donation during and for 4 months after participation in the study.
- Ocular Inclusion Criteria for Study Eye: Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis.
Key exclusion criteria (10 listed)
- Treatment with investigational therapy (anti-VEGF, corticosteroid, laser photocoagulation, panretinal or macular, and PDT) or approved medications for PCV treatment prior to initiation of study treatment on study Day 1.
- Allergy or hypersensitivity to any of the compounds/excipients in the study interventions formulations.
- Uncontrolled blood pressure (defined as systolic >160 mmHg or diastolic >95 mmHg). Participants may be treated with up to 3 agents known to have anti-hypertensive effects for arterial hypertension to achieve adequate blood pressure control. This limit applies to drugs that could be used to treat hypertension even if their primary indication in the participant was not for blood pressure control. Any recent changes in medications known to affect blood pressure need to be stable for 12 weeks prior to screening.
- History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, might affect interpretation of the results of the study, or renders the participant at high risk for treatment complications.
- Any other conditions that the Investigator considers may affect the patients' informed consent or adherence to the study protocol, completion of the test according to the study procedure, or the patients' participation in the test may affect the test results or their own safety.
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 InjectionPatients will be given IVT injection(s) of IMP using standard injection techniques. | Drug | Arm A, Arm B |
Primary outcome
Best Corrected Visual Acuity (BCVA) change at Week 52 after baseline in different treatment regimens.
Time frame: up to 52 Weeks
BCVA (study eye and the fellow eye) examination
10 secondary outcomes
Percentage of patients gaining >15, >10, or ≥5 letters in BCVA after baseline
Time frame: up to 52 Weeks
Percentage of patients achieving complete polypoidal lesion regression at Weeks 52
Time frame: up to 52 Weeks
Percentage of patients with no active polypoidal lesion at Week 52
Time frame: up to 52 Weeks
Change from baseline in central subfield thickness (CST) at Week 12 and 52.
Time frame: up to 12 and 52 Weeks
BCVA change from baseline at Week 12
Time frame: up to 12 Weeks
Percentage of patients achieving Q8W, Q12W, and Q16W treatment intervals at Week 52 in Arm B.
Time frame: up to 52 Weeks
Percentage of patients achieving Q20W of last assigned interval at Week 52 in Arm B.
Time frame: up to 52 Weeks
Percentage of patients achieving ≥12-week, ≥16-week and ≥20-week treatment intervals after completing loading doses in Arm A.
Time frame: up to 52 Weeks
Total number of intravitreal injections administered through Week 52 in both arms.
Time frame: up to 52 Weeks
Incidence and severity of ocular & non-ocular adverse events.
Time frame: up to 52 Weeks
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 26 Jan 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.
20 sites 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 Polypoidal Choroidal Vasculopathy (PCV) and Neovascular Age Related Macular Degeneration (AMD), run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 20 sites 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 6 inclusion and 10 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 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites 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?
Contact Xiaodong Sun (+86-13651765503, xdsun@sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Corrected Visual Acuity (BCVA) change at Week 52 after baseline in different treatment regimens. (time frame: up to 52 Weeks). 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 26 Jan 2026.