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Real-world Study of Aflibercept 8 mg in nAMD

10. juni 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Anslået)

300

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / 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.
Medicin: 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.
Medicin: 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.

Hvad måler undersøgelsen?

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Peking University People's Hospital

Samarbejdspartnere

Bayer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

11. november 2025

Primær færdiggørelse (Anslået)

31. august 2027

Studieafslutning (Anslået)

31. december 2027

Datoer for studieregistrering

Først indsendt

8. december 2025

Først indsendt, der opfyldte QC-kriterier

10. juni 2026

Først opslået (Faktiske)

11. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 23083

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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