Real-world Study of Aflibercept 8 mg in nAMD

Official title

REFLECTION-An Observational Study Program to Investigate the Effectiveness of Aflibercept 8 mg Used in Neovascular Age-related Macular Degeneration (nAMD) in a Real-world Setting.

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.

Interventions

• Drug Aflibercept 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.

Primary outcome measures

• 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 12]

Secondary outcome measures (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 [Time frame: 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 [Time frame: Baseline to Month 12]
• Number of aflibercept 8 mg injections in the study eye during the first 6 months and 12 months [Time frame: Baseline to Month 12]
• 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 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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: Baseline to Month 12]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 27 centers

• Peking University People's Hospital — Beijing
• Beijing CHAO-YANG Hospital, Capital Medical University — Beijing
• Beijing Friendship Hospital, Capital Medical University — Beijing
• Beijing Haidian Hospital — Beijing
• Peking Union Medical College Hospital — Beijing
• Peking University First Hospital — Beijing
• Peking University Third Hospital — Beijing
• The First Affiliated Hospital Of Fujian Medical University — Fuzhou
• … and 19 more centers

Identifiers

NCT: NCT07640997 · 23083

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗