Neovascular Age-Related Macular Degeneration (nAMD)NCT07640997
Real-world Study of Aflibercept 8 mg in nAMD
An observational study of Neovascular Age-Related Macular Degeneration (nAMD), run by Peking University People's Hospital at 27 sites in China.
Trial summary
The goal of this observational study is to explore the effectiveness of aflibercept 8 mg in treating both treatment-naive and previously treated patients with neovascular age-related macular degeneration (nAMD) in a real-world setting. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age-Related Macular Degeneration (nAMD)
- What is being tested?
- Aflibercept 8mg
- How many people
- 300 participants
- Where
- 27 sitesChina
- Study dates
- 11 Nov 2025to 31 Dec 2027
- Phase
- Observational
- 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
Study population: Patients will be enrolled in eye clinics or ophthalmology practices
Who may be able to join
- Patient aged ≥50 years
- A diagnosis of nAMD
- Signed informed patient consent before the start of data collection
- Patients for whom the decision to initiate treatment with IVT aflibercept 8 mg according to a local product information was made as part of routine clinical practice
Who cannot join
- Participation in an investigational program with interventions outside of clinical routine practice
- Contraindications as listed in the intravitreal aflibercept 8 mg local product information (Ocular or periocular infections, severe active intraocular inflammation, and known allergy to aflibercept or any of its excipients)
- The fellow eye has received intravitreal anti-VEGF treatment other than aflibercept within 28 days prior to enrollment
- Intraocular pressure (IOP) in the study eye > 25 mmHg
- Additional exclusion criteria for naïve nAMD patients:
- Any prior ocular treatment in the study eye or systemic treatment for nAMD
Show all 11Show fewer
- Additional exclusion criteria for pretreated nAMD patients:
- Prior intravitreal anti-VEGF treatments in the study eye within the last 28 days
- Prior treatment with intravitreal corticosteroid in the study eye within the last 3 months
- Dexamethasone implant in the study eye within the last 6 months
- Any concurrent drug releasing implant in the study eye
Trial locations and contacts
27 sites in 1 country. Contact the study team or a site near you to ask about taking part.
27 sites in 1 country
China27 sites, 27 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Mingwei Zhao, 13801057408, dr_mingweizhao@163.com
- Not yet recruiting
Beijing CHAO-YANG Hospital, Capital Medical University
Beijing, Beijing Municipality
Yong Tao, +86-13910308908, taoyong@bjcyh.com
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality
Yingxiang Huang, +86-13466652235, bshuang@163.com
- Recruiting
Beijing Haidian Hospital
Beijing, Beijing Municipality
Ang Ji, +86-18518618368, jiang4815@139.com
- Not yet recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality
Weihong Yu, +86-13671214306, yuwh@pumh.cn
- Not yet recruiting
Peking University First Hospital
Beijing, Beijing Municipality
Yun Feng, +86-13911572425, superjune@sina.com
- Not yet recruiting
Peking University Third Hospital
Beijing, Beijing Municipality
Jing Hong, +86-13910573646, hongjing1964@sina.com
- Not yet recruiting
Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital
Chengdu, Sichuan
Jie Zhong, +86-13808063276
- Recruiting
Dalian No.3 People's Hospital
Dalian, Liaoning
Sheng Li, +86-18141159143, leoonnet@163.com
- Not yet recruiting
The First Affiliated Hospital Of Fujian Medical University
Fuzhou, Fujian
Jian Guo, +86-13799395637
- Not yet recruiting
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
Dawei Sun, +86-13304505525, drsundw@126.com
- Not yet recruiting
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia
Dan Zhu, +86-13948113522, zhudan1968@163.com
- Not yet recruiting
Jinan Second People's Hospital
Jinan, Shandong
Changlong Wu, +86-15953129683, wuchanglong911@163.com
- Recruiting
Nanyang Eye Hospital
Nanyang, Henan
Yinwei Li, +86-18537366615
- Not yet recruiting
Ningbo Eye Hospital
Ningbo, Zhejiang
Quanyong Yi, +86-13586543802, quanyong_yi@163.com
- Not yet recruiting
Qingdao Eye Hospital Of Shandong First Medical University
Qingdao, Shandong
Depeng Shi, +86-13953284579, Sdp5300117@126.com
- Not yet recruiting
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality
Tianyu Zheng, +86-15800551771, susu0102@163.com
- Not yet recruiting
TONG REN Hospital, Shanghai Jiao Tong University School Of Medicine
Shanghai, Shanghai Municipality
Qinghua Qiu, +86-13386259756
- Not yet recruiting
The Fourth People's Hospital Of Shenyang
Shenyang, Liaoning
Tongtong Niu, +86-16640566565, 15840566565@163.com
- Not yet recruiting
Shenzhen Eye Hospital
Shenzhen, Guangdong
Wei Chi, +86-13710616456, 1019@szkyy.com
- Not yet recruiting
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality
Xiaorong Li, +86-18622818042, Xiaorli@163.com
- Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality
Wei Zhou, +86-13752020859, 706787566@qq.com
- Not yet recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang
Zipei Jiang, +86-13857795272
- Not yet recruiting
Tongji Hospital Tongji Medical College of HUST
Wuhan, Hubei
Xufang Sun, +86-18627770651, sunxufang@163.com
- Not yet recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Yang Cheng, +86-13396063598, 40338795@qq.com
- Not yet recruiting
Xi'an People's Hospital
Xi'an, Shaanxi
Yanchun Zhang, +86-18992888336, zhangyanchun123@126.com
- Not yet recruiting
Affiliated Hospital Of Zunyi Medical University
Zunyi, Guizhou
Hong Li, +86-18508528884, 596524795@qq.com
About this study
Official title: REFLECTION-An Observational Study Program to Investigate the Effectiveness of Aflibercept 8 mg Used in Neovascular Age-related Macular Degeneration (nAMD) in a Real-world Setting.
The goal of this observational study is to explore the effectiveness of aflibercept 8 mg in treating both treatment-naive and previously treated patients with neovascular age-related macular degeneration (nAMD) in a real-world setting. The main questions it aims to answer are:
What are the short-term and long-term efficacy outcomes of aflibercept 8 mg in treatment-naive or previously treated nAMD patients? What are the safety characteristics and the treatment patterns of aflibercept 8 mg in these patient populations?
Read more
Participants will:
Receive aflibercept 8 mg as part of their clinical treatment for nAMD. Undergo assessments to evaluate both the efficacy and safety of the treatment over the short and long term.
Provide data on their visual acuity (BCVA) changes at multiple follow-up points (4 weeks, 8 weeks, 16 weeks, 6 months, and 12 months).
Report any adverse events and treatment patterns during the study period. Have their central subfield thickness (CST) measured at specified intervals. This study will help inform clinical practices regarding the use of aflibercept in nAMD patients and contribute to understanding its effectiveness and safety in real-world settings.
- Being tested
- Aflibercept 8mg
- Keywords
- nAMD, Aflibercept 8mg, Real World Evidence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept 8mgDrug
Aflibercept 8mg, following the manner of observational study, no intervention will be provided in the study. Any treatment decision, including the decision for aflibercept 8 mg treatment, is at the discretion of the attending physician, made in accordance with his/her experience and follows approved clinical guidelines.
| Study group | Role | What they receive |
|---|---|---|
| naïve nAMD | 200 patients in this group. The observation period for each patient enrolled in this study is the time from the start of therapy with aflibercept 8 mg up to 12 months, withdrawal of consent, switch to any other intravitreal treatment, switch to aflibercept 2 mg in the study eye, pregnancy, death, or when the patient is lost to follow-up. Receives: Drug: Aflibercept 8mg | |
| pretreated nAMD | 100 patients in this group. The observation period for each patient enrolled in this study is the time from the start of therapy with aflibercept 8 mg up to 12 months, withdrawal of consent, switch to any other intravitreal treatment, switch to aflibercept 2 mg in the study eye, pregnancy, death, or when the patient is lost to follow-up. Receives: Drug: Aflibercept 8mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of best corrected visual acuity (BCVA) from baseline to 12 months（BCVA will be examined under real-world conditions and converted into ETDRS letters. ）
Measured: Baseline to Month 12
Secondary outcomes (9)
The change of best corrected visual acuity (BCVA) from baseline to 4 weeks, 8 weeks, 16 weeks, 6 months, and 12 months as evaluated in routine clinical practice
Measured: Baseline to Month 12
The change of central subfield thickness(CST) from baseline to 4 weeks, 8 weeks, 16 weeks, 6 months, and 12 months as evaluated in routine clinical practice
Measured: Baseline to Month 12
Number of aflibercept 8 mg injections in the study eye during the first 6 months and 12 months
Measured: Baseline to Month 12
Number of visits regarding the study eye by type of visit during the 6 months and 12 months treatment period
Measured: Baseline to Month 12
The proportion of study eyes for each treatment regimen (fixed regimen, treatment-extension regimen, as-needed regimen, or other regimens) from baseline to 6 months and 12 months.
Measured: Baseline to Month 12
The proportion of study eyes for the distribution of the last treatment interval from baseline to 6 months and 12 months.
Measured: Baseline to Month 12
The number of patients who experienced (serious) adverse events and (serious) drug-related adverse events from the baseline to 12 months thereafter.
Measured: Baseline to Month 12
Percentage of eyes without IRF and/or SRF in the central macular area at 4 weeks, 8 weeks, 16 weeks, 6 months, and 12 months after the 8 mg injection of Aflibercept compared to before the injection.
Measured: Baseline to Month 12
Percentage of eyes with regression/or improvement of PED at 4 weeks, 8 weeks, 16 weeks, 6 months, and 12 months after the 8 mg injection of Aflibercept compared to before the injection.
Measured: Baseline to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start11 Nov 2025
- Primary completion31 Aug 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 Neovascular Age-Related Macular Degeneration (nAMD)Studies of the same condition, open and under way.
- More trials run by Peking University 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Principal investigator, Mingwei Zhao, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07640997
- Sponsor's protocol ID
- 23083
- Status last verified
- Jun 2026
- First submitted
- 8 Dec 2025
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REFLECTION-An Observational Study Program to Investigate the Effectiveness of Aflibercept 8 mg Used in Neovascular Age-related Macular Degeneration (nAMD) in a Real-world Setting.
- ClinicalTrials.gov ID
- NCT07640997
- Acronym / sponsor ID
- 23083
- Keywords
- nAMD, Aflibercept 8mg, Real World Evidence
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Jun 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 observational study is to explore the effectiveness of aflibercept 8 mg in treating both treatment-naive and previously treated patients with neovascular age-related macular degeneration (nAMD) in a real-world setting. The main questions it aims to answer are:
What are the short-term and long-term efficacy outcomes of aflibercept 8 mg in treatment-naive or previously treated nAMD patients? What are the safety characteristics and the treatment patterns of aflibercept 8 mg in these patient populations?
Participants will:
Receive aflibercept 8 mg as part of their clinical treatment for nAMD. Undergo assessments to evaluate both the efficacy and safety of the treatment over the short and long term.
Provide data on their visual acuity (BCVA) changes at multiple follow-up points (4 weeks, 8 weeks, 16 weeks, 6 months, and 12 months).
Report any adverse events and treatment patterns during the study period. Have their central subfield thickness (CST) measured at specified intervals. This study will help inform clinical practices regarding the use of aflibercept in nAMD patients and contribute to understanding its effectiveness and safety in real-world settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| naïve nAMD | – | Drug: Aflibercept 8mg200 patients in this group. The observation period for each patient enrolled in this study is the time from the start of therapy with aflibercept 8 mg up to 12 months, withdrawal of consent, switch to any other intravitreal treatment, switch to aflibercept 2 mg in the study eye, pregnancy, death, or when the patient is lost to follow-up. |
| pretreated nAMD | – | Drug: Aflibercept 8mg100 patients in this group. The observation period for each patient enrolled in this study is the time from the start of therapy with aflibercept 8 mg up to 12 months, withdrawal of consent, switch to any other intravitreal treatment, switch to aflibercept 2 mg in the study eye, pregnancy, death, or when the patient is lost to follow-up. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be enrolled in eye clinics or ophthalmology practices
Key inclusion criteria (4 listed)
- Patient aged ≥50 years
- A diagnosis of nAMD
- Signed informed patient consent before the start of data collection
- Patients for whom the decision to initiate treatment with IVT aflibercept 8 mg according to a local product information was made as part of routine clinical practice
Key exclusion criteria (11 listed)
- Participation in an investigational program with interventions outside of clinical routine practice
- Contraindications as listed in the intravitreal aflibercept 8 mg local product information (Ocular or periocular infections, severe active intraocular inflammation, and known allergy to aflibercept or any of its excipients)
- The fellow eye has received intravitreal anti-VEGF treatment other than aflibercept within 28 days prior to enrollment
- Intraocular pressure (IOP) in the study eye > 25 mmHg
- Additional exclusion criteria for naïve nAMD patients:
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 8mgAflibercept 8mg, following the manner of observational study, no intervention will be provided in the study. Any treatment decision, including the decision for aflibercept 8 mg treatment, is at the discretion of the attending physician, made in accordance with his/her experience and follows approved clinical guidelines. | Drug | naïve nAMD, pretreated nAMD |
Primary outcome
The change of best corrected visual acuity (BCVA) from baseline to 12 months（BCVA will be examined under real-world conditions and converted into ETDRS letters. ）
Time frame: Baseline to Month 12
9 secondary outcomes
The change of best corrected visual acuity (BCVA) from baseline to 4 weeks, 8 weeks, 16 weeks, 6 months, and 12 months as evaluated in routine clinical practice
Time frame: Baseline to Month 12
The change of central subfield thickness(CST) from baseline to 4 weeks, 8 weeks, 16 weeks, 6 months, and 12 months as evaluated in routine clinical practice
Time frame: Baseline to Month 12
Number of aflibercept 8 mg injections in the study eye during the first 6 months and 12 months
Time frame: Baseline to Month 12
Number of visits regarding the study eye by type of visit during the 6 months and 12 months treatment period
Time frame: Baseline to Month 12
The proportion of study eyes for each treatment regimen (fixed regimen, treatment-extension regimen, as-needed regimen, or other regimens) from baseline to 6 months and 12 months.
Time frame: Baseline to Month 12
The proportion of study eyes for the distribution of the last treatment interval from baseline to 6 months and 12 months.
Time frame: Baseline to Month 12
The number of patients who experienced (serious) adverse events and (serious) drug-related adverse events from the baseline to 12 months thereafter.
Time frame: Baseline to Month 12
Percentage of eyes without IRF and/or SRF in the central macular area at 4 weeks, 8 weeks, 16 weeks, 6 months, and 12 months after the 8 mg injection of Aflibercept compared to before the injection.
Time frame: Baseline to Month 12
Percentage of eyes with regression/or improvement of PED at 4 weeks, 8 weeks, 16 weeks, 6 months, and 12 months after the 8 mg injection of Aflibercept compared to before the injection.
Time frame: Baseline to Month 12
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 11 Jun 2026.
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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.
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neovascular Age-Related Macular Degeneration (nAMD), run by Peking University People's Hospital at 27 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 4 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 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.
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 Mingwei Zhao (+86 13801057408, dr_zhaomingwei@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of best corrected visual acuity (BCVA) from baseline to 12 months（BCVA will be examined under real-world conditions and converted into ETDRS letters. ） (time frame: Baseline to Month 12). 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 11 Jun 2026.