Neovascular Age-Related Macular Degeneration (nAMD)
Conditions
Keywords
nAMD, Aflibercept 8mg, Real World Evidence
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.
Interventions
DRUGAflibercept 8mg
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.
Sponsors
Peking University People's Hospital
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| The proportion of study eyes for the distribution of the last treatment interval from baseline to 6 months and 12 months. | 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. | 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. | 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. | Baseline to Month 12 |
Countries
China
Contacts
CONTACTMingwei Zhao
Outcome results
None listed