Intraocular Cytokines in Non-responders to Ranibizumab Treatment for Neovascular AMD
Neovascular Age-related Macular Degeneration: Intraocular Inflammatory Cytokines in the Non-responder to Ranibizumab Treatment
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Ontario
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Toronto, Ontario, Canada, M2N4H3
- Toronto Western Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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Non-responders receiving aflibercept therapy
Non-responders to ranibizumab who are now receiving aflibercept therapy
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anti-VEGF treatment for wet age related macular degeneration
Altri nomi:
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Non-responders receiving PDT combo therapy
patients who are non-responders to ranibizumab who have been switched to combination photodynamic therapy (PDT)
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Use of cold laser with an intravitreal injection of dexamethasone to treat wet age related macular degeneration
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Responders to ranibizumab
Patients who are responders to ranibizumab and are continuing monthly injections.
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anti-VEGF treatment for wet age related macular degeneration
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Aqueous Humour Cytokine Levels
Lasso di tempo: At time of Intravitreal Injection
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At time of Intravitreal Injection
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Demographic Data
Lasso di tempo: At time of appointment
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At time of appointment
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Number of anti-VEGF injections before developing non-responder characteristics
Lasso di tempo: At time of appointment
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At time of appointment
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History of Previous Treatment
Lasso di tempo: At time of appointment
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At time of appointment
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Optical Coherence Tomography (OCT) results
Lasso di tempo: At time of appointment
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At time of appointment
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Fluorescein Angiography Results and Indocyanine Green Angiography Results
Lasso di tempo: At time of appointment
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At time of appointment
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Wai-Ching Lam, MD, Toronto Western Hospital, University Health Network, University of Toronto
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- VEGF wAMD cytokine study
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .