Real-world Study of Aflibercept 8 mg in nAMD

Peking University People's Hospital300 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

300

Conditions

Neovascular Age-Related Macular Degeneration (nAMD)

Interventions

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.

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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 exclusion criteria for naïve nAMD patients: * Any prior ocular treatment in the study eye or systemic treatment for nAMD * 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

Locations (27)

Peking University People's Hospital

Beijing, Beijing Municipality, China

RECRUITING

Beijing CHAO-YANG Hospital, Capital Medical University

Beijing, Beijing Municipality, China

NOT_YET_RECRUITING

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

Beijing Haidian Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

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. ）