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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. maj 2019 opdateret af: 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).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1049

Fase

  • Fase 4

Kontakter og lokationer

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

Studiesteder

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

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

50 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Ranibizumab
Administered as an Intravitreal injection
Medicin: 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).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

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

Sponsor

Novartis Pharmaceuticals

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)

4. marts 2014

Primær færdiggørelse (Faktiske)

15. juni 2016

Studieafslutning (Faktiske)

15. juni 2016

Datoer for studieregistrering

Først indsendt

12. november 2013

Først indsendt, der opfyldte QC-kriterier

12. november 2013

Først opslået (Skøn)

19. november 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. juli 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. maj 2019

Sidst verificeret

1. maj 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

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 .

Kliniske forsøg med ranibizumab

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Benin

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner