Real-world Study of Aflibercept 8 mg in nAMD
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorPeking University People's Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Aflibercept 8mg
Treatment groups
300 Participants
are divided into 2 treatment groupsSponsors and collaborators
Peking University People's Hospital
Lead sponsor
Bayer
Collaborator
Source ClinicalTrials.gov