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
This trial does not accept healthy volunteersQualifiers
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 population
Patients will be enrolled in eye clinics or ophthalmology practices
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Aflibercept 8mg
DrugAflibercept 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.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: naïve nAMD1 intervention
Group B: pretreated nAMD1 intervention
Trial outcomes
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. ）
Time frame
Baseline to Month 12Secondary outcomes
1
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 122
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 123
Number of aflibercept 8 mg injections in the study eye during the first 6 months and 12 months
Time frame
Baseline to Month 124
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 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Peking University People's Hospital
Lead sponsor
Bayer
Collaborator
Source ClinicalTrials.gov