Brief 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. 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

300

participants targeted

Target at P75+ for all trials

Timeline

19mo left

Started Nov 2025

Typical duration for all trials

Geographic Reach

1 country

27 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.1 years study duration

Study Progress28%

Nov 2025Dec 2027

Study Start

First participant enrolled

November 11, 2025

Completed

27 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2025

Completed

6 months until next milestone

First Posted

Study publicly available on registry

June 11, 2026

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

Expected

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

1.8 years

First QC Date

December 8, 2025

Last Update Submit

June 10, 2026

Conditions

Neovascular Age-Related Macular Degeneration (nAMD)

Keywords

nAMDAflibercept 8mgReal World Evidence

Outcome Measures

Primary Outcomes (1)

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. ）
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
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
Baseline to Month 12
Number of aflibercept 8 mg injections in the study eye during the first 6 months and 12 months
Baseline to Month 12
Number of visits regarding the study eye by type of visit during the 6 months and 12 months treatment period
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.
Baseline to Month 12
+4 more secondary outcomes

Study Arms (2)

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.

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.

Drug: Aflibercept 8mg

Interventions

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.

naïve nAMDpretreated nAMD

Eligibility Criteria

Age50 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients will be enrolled in eye clinics or ophthalmology practices

You may qualify if:

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

You may not qualify if:

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
Any prior ocular treatment in the study eye or systemic treatment for nAMD
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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Peking University People's Hospitallead
Bayercollaborator

Study Sites (27)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Beijing CHAO-YANG Hospital, Capital Medical University