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Safety and Tolerability of Ranibizumab in Mono/Bilateral Wet Age Related Macular Degeneration (w-AMD) Patients in Eyes With BCVA<2/10 and/or 2nd Affected Eye (TWEYES)

11. mai 2019 oppdatert av: Novartis Pharmaceuticals

A 12 Months, Prospective, Multicenter, Open-label, Single Arm Interventional Study Assessing the Safety and Tolerability of 0.5 mg Ranibizumab in Mono/Bilateral Wet AMD Patients in Eyes With (Best-Corrected Distance Visual Acuity) BCVA Below 2/10 and/or Second Affected Eye

The purpose of this study is to evaluate the safety and efficacy of ranibizumab in patients affected by wet age related macular degeneration (wAMD).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

1049

Fase

  • Fase 4

Kontakter og plasseringer

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

Studiesteder

  • Italia
      • Borgomanero, Italia, 28021
        • Novartis Investigative Site
      • Galliate, Italia, 28066
        • Novartis Investigative Site
      • Napoli, Italia, 80131
        • Novartis Investigative Site
      • Napoli, Italia, 80132
        • Novartis Investigative Site
      • Napoli, Italia, 80138
        • Novartis Investigative Site
      • Pozzuoli, Italia, 80078
        • Novartis Investigative Site
    • AL
      • Alessandria, AL, Italia, 15100
        • Novartis Investigative Site
      • Casale Monferrato, AL, Italia, 15033
        • Novartis Investigative Site
    • AN
      • Ancona, AN, Italia, 60126
        • Novartis Investigative Site
    • BA
      • Acquaviva delle Fonti, BA, Italia, 70021
        • Novartis Investigative Site
      • Putignano, BA, Italia, 70017
        • Novartis Investigative Site
      • Terlizzi, BA, Italia, 70038
        • Novartis Investigative Site
    • BG
      • Bergamo, BG, Italia, 24127
        • Novartis Investigative Site
    • BL
      • Belluno, BL, Italia, 32100
        • Novartis Investigative Site
    • BO
      • Bologna, BO, Italia, 40138
        • Novartis Investigative Site
    • BS
      • Brescia, BS, Italia, 25123
        • Novartis Investigative Site
      • Desenzano del Garda, BS, Italia, 25015
        • Novartis Investigative Site
    • BZ
      • Bolzano, BZ, Italia, 39100
        • Novartis Investigative Site
    • CA
      • Cagliari, CA, Italia, 09124
        • Novartis Investigative Site
    • CB
      • Larino, CB, Italia
        • Novartis Investigative Site
    • CE
      • Caserta, CE, Italia, 81100
        • Novartis Investigative Site
    • CH
      • Chieti, CH, Italia, 66100
        • Novartis Investigative Site
    • CN
      • Ceva, CN, Italia, 12073
        • Novartis Investigative Site
      • Cuneo, CN, Italia, 12100
        • Novartis Investigative Site
    • CO
      • Como, CO, Italia, 22100
        • Novartis Investigative Site
      • San Feramo Della Battaglia, CO, Italia, 22020
        • Novartis Investigative Site
    • CT
      • Acireale, CT, Italia, 95024
        • Novartis Investigative Site
      • Catania, CT, Italia, 95124
        • Novartis Investigative Site
      • Catania, CT, Italia, 95123
        • Novartis Investigative Site
    • CZ
      • Catanzaro, CZ, Italia, 88100
        • Novartis Investigative Site
    • FC
      • Forlì, FC, Italia, 47100
        • Novartis Investigative Site
    • FE
      • Cona, FE, Italia, 44100
        • Novartis Investigative Site
    • FG
      • Foggia, FG, Italia, 71100
        • Novartis Investigative Site
      • San Giovanni Rotondo, FG, Italia, 71013
        • Novartis Investigative Site
    • GE
      • Genova, GE, Italia, 16132
        • Novartis Investigative Site
      • Genova, GE, Italia, 16153
        • Novartis Investigative Site
      • Rapallo, GE, Italia, 16035
        • Novartis Investigative Site
    • KR
      • Crotone, KR, Italia, 88074
        • Novartis Investigative Site
    • LE
      • Tricase, LE, Italia, 73039
        • Novartis Investigative Site
    • LT
      • Terracina, LT, Italia, 04019
        • Novartis Investigative Site
    • ME
      • Messina, ME, Italia, 98125
        • Novartis Investigative Site
      • Milazzo, ME, Italia, 98057
        • Novartis Investigative Site
    • MI
      • Cinisello Balsamo, MI, Italia, 20092
        • Novartis Investigative Site
      • Legnano, MI, Italia, 20025
        • Novartis Investigative Site
      • Milano, MI, Italia, 20132
        • Novartis Investigative Site
      • Milano, MI, Italia, 20122
        • Novartis Investigative Site
      • Milano, MI, Italia, 20123
        • Novartis Investigative Site
      • Milano, MI, Italia, 20100
        • Novartis Investigative Site
      • Milano, MI, Italia, 20142
        • Novartis Investigative Site
      • Rozzano, MI, Italia, 20089
        • Novartis Investigative Site
      • Vizzolo Predabissi, MI, Italia, 20070
        • Novartis Investigative Site
    • NU
      • Nuoro, NU, Italia, 08100
        • Novartis Investigative Site
    • PA
      • Palermo, PA, Italia, 90127
        • Novartis Investigative Site
      • Palermo, PA, Italia, 90146
        • Novartis Investigative Site
    • PC
      • Piacenza, PC, Italia, 29100
        • Novartis Investigative Site
    • PD
      • Camposampiero, PD, Italia, 35012
        • Novartis Investigative Site
      • Monselice, PD, Italia, 35043
        • Novartis Investigative Site
      • Padova, PD, Italia, 35128
        • Novartis Investigative Site
      • Padova, PD, Italia, 35100
        • Novartis Investigative Site
    • PE
      • Pescara, PE, Italia, 65124
        • Novartis Investigative Site
    • PG
      • Citta' di Castello, PG, Italia, 06012
        • Novartis Investigative Site
      • Foligno, PG, Italia, 06034
        • Novartis Investigative Site
      • Perugia, PG, Italia, 06100
        • Novartis Investigative Site
    • PN
      • Pordenone, PN, Italia, 33170
        • Novartis Investigative Site
    • PR
      • Parma, PR, Italia, 43100
        • Novartis Investigative Site
    • PV
      • Pavia, PV, Italia, 27100
        • Novartis Investigative Site
    • RC
      • Reggio Calabria, RC, Italia, 89124
        • Novartis Investigative Site
    • RE
      • Correggio, RE, Italia, 42015
        • Novartis Investigative Site
      • Reggio Emilia, RE, Italia, 42123
        • Novartis Investigative Site
    • RM
      • Civitavecchia, RM, Italia, 00053
        • Novartis Investigative Site
      • Roma, RM, Italia, 00168
        • Novartis Investigative Site
      • Roma, RM, Italia, 00161
        • Novartis Investigative Site
      • Roma, RM, Italia, 00133
        • Novartis Investigative Site
      • Roma, RM, Italia, 00184
        • Novartis Investigative Site
      • Roma, RM, Italia, 00189
        • Novartis Investigative Site
      • Roma, RM, Italia, 00186
        • Novartis Investigative Site
    • RN
      • Riccione, RN, Italia, 47838
        • Novartis Investigative Site
    • SA
      • Eboli, SA, Italia, 84025
        • Novartis Investigative Site
      • Salerno, SA, Italia, 84131
        • Novartis Investigative Site
    • SO
      • Sondrio, SO, Italia, 23100
        • Novartis Investigative Site
    • SP
      • Sarzana, SP, Italia, 19038
        • Novartis Investigative Site
    • SS
      • Sassari, SS, Italia, 07100
        • Novartis Investigative Site
    • SV
      • Savona, SV, Italia, 17100
        • Novartis Investigative Site
    • TA
      • Taranto, TA, Italia, 74100
        • Novartis Investigative Site
    • TE
      • Teramo, TE, Italia, 64100
        • Novartis Investigative Site
    • TO
      • Torino, TO, Italia, 10122
        • Novartis Investigative Site
      • Torino, TO, Italia, 10153
        • Novartis Investigative Site
      • Torino, TO, Italia, 10152
        • Novartis Investigative Site
    • TR
      • Terni, TR, Italia, 05100
        • Novartis Investigative Site
    • TS
      • Trieste, TS, Italia, 34129
        • Novartis Investigative Site
    • TV
      • Conegliano, TV, Italia, 31015
        • Novartis Investigative Site
      • Treviso, TV, Italia, 31100
        • Novartis Investigative Site
    • UD
      • Udine, UD, Italia, 33100
        • Novartis Investigative Site
    • VA
      • Busto Arsizio, VA, Italia, 21052
        • Novartis Investigative Site
      • Somma Lombardo, VA, Italia, 21019
        • Novartis Investigative Site
      • Varese, VA, Italia, 21100
        • Novartis Investigative Site
    • VI
      • Santorso, VI, Italia, 36014
        • Novartis Investigative Site
      • Vicenza, VI, Italia, 36100
        • Novartis Investigative Site
    • VR
      • Legnago, VR, Italia, 37045
        • Novartis Investigative Site
      • Negrar, VR, Italia, 37024
        • Novartis Investigative Site
      • Verona, VR, Italia, 37126
        • Novartis Investigative Site

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

50 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria

Male or female patients aged 50 years or above Willing and capable to provide informed written consent Eye(s) eligible for ranibizumab treatment, with a BCVA below 2/10 due to wet AMD and/or Second eye eligible for ranibizumab treatment, with first eye treated (currently or previously) with ranibizumab, whichever BCVA. In bilateral wAMD patients, the second eye can be included only if the first eye has been treated at least 14 days before with ranibizumab

Exclusion Criteria:

Active intraocular inflammation (grade trace or above) in either eye Any ocular or periocular active infection (current or suspected), e.g. conjunctivitis, keratitis, scleritis, uveitis, endophtalmitis, in either eye Risk factors for retinal pigment epithelial tear (including pigment epithelial retinal detachment) Ocular disorders that may confound interpretation of results compromise visual acuity or require medical or surgical intervention during the study period including cataract, retinal vascular occlusion, retinal detachment or macular hole Uncontrolled glaucoma in either eye (IOP ≥ 30 mmHg on medication or according to investigator's judgment) History of vitrectomy in the study eye History of stroke or transient ischemic attack Systemic treatment with any VEGF inhibitor in the 90 days prior to study enrollment Ocular treatment of the study eye with any anti-angiogenic drugs within 1 month prior to study enrollment Any intraocular surgery in the study eye within 28 days prior to enrollment Women of childbearing potential UNLESS using effective contraception during treatment Pregnant or lactating women Simultaneous participation in a study that includes administration of any investigational drug Known hypersensitivity to ranibizumab or any component of the ranibizumab formulation Inability to comply with study procedures.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Ranibizumab
Administered as an Intravitreal injection
Legemiddel: ranibizumab
All patients will receive ranibizumab 0.5 mg/0.05 ml according to approved label: treatment is given monthly until maximum VA is achieved (i.e. stable VA for three consecutive monthly assessments performed while on ranibizumab treatment). Thereafter according to approved label, patients should be monitored monthly for visual acuity and treatment is to be resumed when monitoring indicates loss of visual acuity due to disease activity. Monthly injections should then be administered until stable visual acuity is reached again for three consecutive monthly assessments (implying a minimum of two injections).

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants With Systemic Drug-related Adverse Events
Tidsramme: Baseline to Month 12
Monitoring and recording all adverse events, including serious adverse events.
Baseline to Month 12
Number of Eyes With Ocular Drug-related Adverse Events
Tidsramme: Baseline to Month 12
Monitoring and recording all adverse events, including serious adverse events.
Baseline to Month 12

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall Number of Ranibizumab Injections
Tidsramme: Baseline to month 12
Baseline to month 12
Time Interval Between Injections in Bilateral Disease
Tidsramme: Baseline to month 12
Mean number of days between two consecutive injections per eye
Baseline to month 12
Mean Number of Injections Per Patient
Tidsramme: Baseline to month 12
Number of injections per patient
Baseline to month 12

Samarbeidspartnere og etterforskere

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

Sponsor

Novartis Pharmaceuticals

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)

4. mars 2014

Primær fullføring (Faktiske)

15. juni 2016

Studiet fullført (Faktiske)

15. juni 2016

Datoer for studieregistrering

Først innsendt

12. november 2013

Først innsendt som oppfylte QC-kriteriene

12. november 2013

Først lagt ut (Anslag)

19. november 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

19. juli 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. mai 2019

Sist bekreftet

1. mai 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CRFB002AIT02
  • 2013-003333-15 (EudraCT-nummer)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

IPD-planbeskrivelse

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

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. .

Kliniske studier på ranibizumab

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Panama

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

Abonnere