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Real-world Study of Aflibercept 8 mg in nAMD

10. juni 2026 oppdatert av: Mingwei Zhao, Peking University People's Hospital

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.

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Antatt)

300

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina
        • Har ikke rekruttert ennå
        • Peking University First Hospital
        • Ta kontakt med:
      • Beijing, Beijing Municipality, Kina
        • Har ikke rekruttert ennå
        • Peking University Third Hospital
        • Ta kontakt med:
      • Beijing, Beijing Municipality, Kina, 100044
        • Rekruttering
        • Peking University People's Hospital
        • Ta kontakt med:
      • Beijing, Beijing Municipality, Kina
        • Rekruttering
        • Beijing Friendship Hospital, Capital Medical University
        • Ta kontakt med:
      • Beijing, Beijing Municipality, Kina
        • Har ikke rekruttert ennå
        • Peking Union Medical College Hospital
        • Ta kontakt med:
          • Weihong Yu
          • Telefonnummer: +86-13671214306
          • E-post: yuwh@pumh.cn
      • Beijing, Beijing Municipality, Kina
        • Har ikke rekruttert ennå
        • Beijing CHAO-YANG Hospital, Capital Medical University
        • Ta kontakt med:
      • Beijing, Beijing Municipality, Kina
        • Rekruttering
        • Beijing Haidian Hospital
        • Ta kontakt med:
    • Fujian
      • Fuzhou, Fujian, Kina
        • Har ikke rekruttert ennå
        • The First Affiliated Hospital of Fujian Medical University
        • Ta kontakt med:
          • Jian Guo
          • Telefonnummer: +86-13799395637
    • Guangdong
      • Shenzhen, Guangdong, Kina
        • Har ikke rekruttert ennå
        • Shenzhen Eye Hospital
        • Ta kontakt med:
    • Guizhou
      • Zunyi, Guizhou, Kina
        • Har ikke rekruttert ennå
        • Affiliated Hospital Of Zunyi Medical University
        • Ta kontakt med:
    • Heilongjiang
      • Harbin, Heilongjiang, Kina
        • Har ikke rekruttert ennå
        • The 2nd Affiliated Hospital of Harbin Medical University
        • Ta kontakt med:
    • Henan
      • Nanyang, Henan, Kina
        • Rekruttering
        • Nanyang Eye Hospital
        • Ta kontakt med:
          • Yinwei Li
          • Telefonnummer: +86-18537366615
    • Hubei
      • Wuhan, Hubei, Kina
        • Har ikke rekruttert ennå
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Ta kontakt med:
      • Wuhan, Hubei, Kina
        • Har ikke rekruttert ennå
        • Tongji Hospital Tongji Medical College of HUST
        • Ta kontakt med:
    • Inner Mongolia
      • Hohhot, Inner Mongolia, Kina
        • Har ikke rekruttert ennå
        • The Affiliated Hospital of Inner Mongolia Medical University
        • Ta kontakt med:
    • Liaoning
      • Dalian, Liaoning, Kina
        • Rekruttering
        • Dalian No.3 People's Hospital
        • Ta kontakt med:
      • Shenyang, Liaoning, Kina
        • Har ikke rekruttert ennå
        • The Fourth People's Hospital Of Shenyang
        • Ta kontakt med:
    • Shaanxi
      • Xi'an, Shaanxi, Kina
        • Har ikke rekruttert ennå
        • Xi'an People's Hospital
        • Ta kontakt med:
    • Shandong
      • Jinan, Shandong, Kina
        • Har ikke rekruttert ennå
        • Jinan Second People's Hospital
        • Ta kontakt med:
      • Qingdao, Shandong, Kina
        • Har ikke rekruttert ennå
        • Qingdao Eye Hospital Of Shandong First Medical University
        • Ta kontakt med:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina
        • Har ikke rekruttert ennå
        • Shanghai Tenth People's Hospital
        • Ta kontakt med:
      • Shanghai, Shanghai Municipality, Kina
        • Har ikke rekruttert ennå
        • TONG REN Hospital, Shanghai Jiao Tong University School Of Medicine
        • Ta kontakt med:
          • Qinghua Qiu
          • Telefonnummer: +86-13386259756
    • Sichuan
      • Chengdu, Sichuan, Kina
        • Har ikke rekruttert ennå
        • Sichuan Academy of Medical Sciences - Sichuan Provincial People's Hospital
        • Ta kontakt med:
          • Jie Zhong
          • Telefonnummer: +86-13808063276
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Kina
        • Rekruttering
        • Tianjin Medical University General Hospital
        • Ta kontakt med:
      • Tianjin, Tianjin Municipality, Kina
        • Har ikke rekruttert ennå
        • Tianjin Medical University Eye Hospital
        • Ta kontakt med:
    • Zhejiang
      • Ningbo, Zhejiang, Kina
        • Har ikke rekruttert ennå
        • Ningbo Eye Hospital
        • Ta kontakt med:
      • Wenzhou, Zhejiang, Kina
        • Har ikke rekruttert ennå
        • The First Affiliated Hospital of Wenzhou Medical University
        • Ta kontakt med:
          • Zipei Jiang
          • Telefonnummer: +86-13857795272

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Patients will be enrolled in eye clinics or ophthalmology practices

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
naïve nAMD
200 patients in this group. The observation period for each patient enrolled in this study is the time from the start of therapy with aflibercept 8 mg up to 12 months, withdrawal of consent, switch to any other intravitreal treatment, switch to aflibercept 2 mg in the study eye, pregnancy, death, or when the patient is lost to follow-up.
Legemiddel: 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.
pretreated nAMD
100 patients in this group. The observation period for each patient enrolled in this study is the time from the start of therapy with aflibercept 8 mg up to 12 months, withdrawal of consent, switch to any other intravitreal treatment, switch to aflibercept 2 mg in the study eye, pregnancy, death, or when the patient is lost to follow-up.
Legemiddel: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
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. ）
Tidsramme: Baseline to Month 12
Baseline to Month 12

Sekundære resultatmål

Resultatmål
Tidsramme
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
Tidsramme: Baseline to Month 12
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
Tidsramme: Baseline to Month 12
Baseline to Month 12
Number of aflibercept 8 mg injections in the study eye during the first 6 months and 12 months
Tidsramme: Baseline to Month 12
Baseline to Month 12
Number of visits regarding the study eye by type of visit during the 6 months and 12 months treatment period
Tidsramme: Baseline to Month 12
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.
Tidsramme: Baseline to Month 12
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.
Tidsramme: Baseline to Month 12
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.
Tidsramme: Baseline to Month 12
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.
Tidsramme: Baseline to Month 12
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.
Tidsramme: Baseline to Month 12
Baseline to Month 12

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Peking University People's Hospital

Samarbeidspartnere

Bayer

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

11. november 2025

Primær fullføring (Antatt)

31. august 2027

Studiet fullført (Antatt)

31. desember 2027

Datoer for studieregistrering

Først innsendt

8. desember 2025

Først innsendt som oppfylte QC-kriteriene

10. juni 2026

Først lagt ut (Faktiske)

11. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

11. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 23083

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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