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Real-world Study of Aflibercept 8 mg in nAMD

10 juni 2026 uppdaterad 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Observationell

Inskrivning (Beräknad)

300

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Patients will be enrolled in eye clinics or ophthalmology practices

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
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.
Läkemedel: 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.
Läkemedel: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
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. ）
Tidsram: Baseline to Month 12
Baseline to Month 12

Sekundära resultatmått

Resultatmått
Tidsram
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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: Baseline to Month 12
Baseline to Month 12

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Peking University People's Hospital

Samarbetspartners

Bayer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

11 november 2025

Primärt slutförande (Beräknad)

31 augusti 2027

Avslutad studie (Beräknad)

31 december 2027

Studieregistreringsdatum

Först inskickad

8 december 2025

Först inskickad som uppfyllde QC-kriterierna

10 juni 2026

Första postat (Faktisk)

11 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

11 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

10 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 23083

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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