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Intraocular Cytokines in Non-responders to Ranibizumab Treatment for Neovascular AMD

9. oktober 2018 opdateret af: Wai-Ching Lam, University Health Network, Toronto

Neovascular Age-related Macular Degeneration: Intraocular Inflammatory Cytokines in the Non-responder to Ranibizumab Treatment

The purpose of this study is to evaluate the level of cytokines (which are small proteins important in cell signalling) in eye fluid (aqueous humour) in patients with wet age related macular degeneration patients who have been treated with an injection in the eye (intravitreal injection) with a drug called ranibizumab. The level of cytokines will be compared between patients who have a good response to ranibizumab treatment and patients who are non-responsive to ranibizumab and need other forms of therapy. This knowledge will help for the future treatment and to potentially develop new medication for wet age-related macular degeneration.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

In the treatment of CNV (Choroidal NeoVascularization) secondary from AMD (Age Related Macular Degeneration) by using ranibizumab, patients who are non-responders can be found in approximately 1-10% of treatments. Thus, failure of treatment can lead to loss of vision. Growth factors and cytokines, such as vascular endothelial growth factor (VEGF), pigment epithelium derived factor (PEDF), interleukin 6 (IL-6) and placenta growth factor (PLGF) are known to play an important role in the development of CNV angiogenesis.

The rationale for conducting this study to compare VEGF, PEDF, IL-6 and PLGF cytokine levels in the aqueous humor of wet AMD and Polypoidal Choroidal Vasculopathy (PCV) patients who are poor responders to anti VEGF treatment and age-matched "good" responders to anti VEGF. Ranibizumab poor responders in AMD and PCV, who are treated with a combination of PDT/ranibizumab or intravitreous injection of aflibercept (Eyelea®, Regeneron Pharmaceuticals Inc. Tarrytown, NY, USA and Bayer, Basel, Switzerland) will be enrolled to the study. An aqueous humor sample will be obtained when patient receives intravitreal injection treatment and also at 1, 2 months follow up period. VEGF, PEDF,IL-6 and PLGF in aqueous will be analyzed and used to compare between the poor response group and age matched patient with good response to ranibizumab. Age, gender, visual acuity, central macular thickness by OCT, lesion size and fundus autofluorescence data will be collected and used to compare between these groups. Subgroup analysis of different treatment comparison with ranibizumab good responder group will be evaluated. Factors associated with the non-responders of ranibizumab will be analyzed.

Non-responders to ranibizumab treatment in AMD may have different levels and responses of inflammatory cytokines compared to the responder group. Understanding the pathogenesis and characteristic of this specific group of patients can help narrow down a specific choice of treatment and prevent the reduction of visual acuity of the patient. This study also helps identify factors associated to poor responders from ranibizumab treatment for wAMD.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

30

Kontakter og lokationer

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

Studiesteder

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M2N4H3
        • Toronto Western Hospital

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Study patients in the treatment group will be those greater than 50 years old, with age related macular degeneration, who are non-responder/ resistance to ranibizumab treatment. Control group will include patients who are responders to ranibizumab treatment.

Beskrivelse

Inclusion Criteria:

  • Age 50 years or more
  • Ranibizumab resistance/poor responder patients in all AMD entities (typical AMD, PCV and RAP) who will be treated with intravitreous ranibizumab in combination with verteporfin photodynamic therapy
  • Ranibizumab resistance/poor responder patients in all AMD entity (typical AMD, PCV and RAP) who will be treated with intravitreous aflibercept injection
  • AMD patient who is good response to the treatment of ranibizumab (control group)

Exclusion Criteria:

  • Any evidence of good response in treatment of ranibizumab,
  • Uncooperative patients to intravitreal treatment
  • Patients who have clinically active ocular inflammation
  • Patients who have previous PDT treatment within 6 months
  • Patient who previously have ocular treatment of immunosuppressive agent within 3 months
  • Patient who previously have ocular treatment of steroid with in 3 months
  • Patients who are currently on systemic treatment of anti-VEGF medication or immunosuppressive agents.

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
Non-responders receiving aflibercept therapy
Non-responders to ranibizumab who are now receiving aflibercept therapy
Medicin: Aflibercept
anti-VEGF treatment for wet age related macular degeneration
Andre navne:
  • Eylea (R)
Non-responders receiving PDT combo therapy
patients who are non-responders to ranibizumab who have been switched to combination photodynamic therapy (PDT)
Procedure: Combination Photodynamic Therapy
Use of cold laser with an intravitreal injection of dexamethasone to treat wet age related macular degeneration
Responders to ranibizumab
Patients who are responders to ranibizumab and are continuing monthly injections.
Medicin: Ranibizumab
anti-VEGF treatment for wet age related macular degeneration
Andre navne:
  • Lucentis

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Aqueous Humour Cytokine Levels
Tidsramme: At time of Intravitreal Injection
At time of Intravitreal Injection

Sekundære resultatmål

Resultatmål
Tidsramme
Demographic Data
Tidsramme: At time of appointment
At time of appointment
Number of anti-VEGF injections before developing non-responder characteristics
Tidsramme: At time of appointment
At time of appointment
History of Previous Treatment
Tidsramme: At time of appointment
At time of appointment
Optical Coherence Tomography (OCT) results
Tidsramme: At time of appointment
At time of appointment
Fluorescein Angiography Results and Indocyanine Green Angiography Results
Tidsramme: At time of appointment
At time of appointment

Samarbejdspartnere og efterforskere

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

Sponsor

University Health Network, Toronto

Efterforskere

  • Ledende efterforsker: Wai-Ching Lam, MD, Toronto Western Hospital, University Health Network, University of Toronto

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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

1. august 2014

Primær færdiggørelse (Faktiske)

1. august 2016

Studieafslutning (Faktiske)

1. december 2016

Datoer for studieregistrering

Først indsendt

13. august 2014

Først indsendt, der opfyldte QC-kriterier

13. august 2014

Først opslået (Skøn)

18. august 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. oktober 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. oktober 2018

Sidst verificeret

1. oktober 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • VEGF wAMD cytokine study

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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