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Pilot Study Reduced Fluence PDT /Visudyne With Ranibizumab vs Ranibizumab Monotherapy for Exudative Age-related Macular Degeneration (AMD)

9. maj 2012 opdateret af: Lahey Clinic

A Pilot Study With Reduced Fluence Photodynamic Therapy With Visudyne Ranibizumab VS. Ranibizumab Only to Treat Exudative AMD

The purposes of this study is to determine if combination reduced fluence photodynamic therapy and Ranibizumab has:

Similar efficacy to Ranibizumab (Lucentis) alone. The ability to reduce the number of intravitreal injection of Ranibizumab or a 13 month period The ability to reduce the number of PDT treatments. The study will also collect information on the safety of combination therapy and single therapy.

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This will be a 13 month prospective, blinded, randomized sham controled parallel safety study. There will be 2 treatment arms.

Arm 1 will receive reduced fluence PDT at baseline followed immediately by an intravitreal injection of Lucentis. Subjects in arm 1 will receive 2 additional injections of Ranibizumab (Lucentis) over the next 2 months. Starting at month 3, they will receive combination reduced fluence PDT and intravitreal Ranibizumab (Lucentis) if they develop recurrence of the subretinal fluid, cystoid macular edema, increased pigment epithelial detachment (PED), or increased retinal thickness > 100 microns compared to the best prior thickness measure on OCT. Patients will be eligible for repeat combination reduced fluence PDT + intravitreal Ranibizumab (Lucentis) every 3 months thereafter. Group 1 patients are eligible for treatment with combination reduced fluence PDT and Ranibizumab (Lucentis) at any point at the 3 month time point or thereafter. After month 3, if patients were not eligible for combined therapy (<3 months since the last combination therapy) and have >2 lines of vision loss or > 100 microns of increased retinal thickness on OCT compared to most recent measure at their monthly visit, they would be eligible for an injection of Ranibizumab (Lucentis) as monotherapy. Thereafter, subjects will have combination therapy if retreatment criteria were met and it has been >3 months since the last PDT treatment.

Study arm 2 will receive 3 monthly intravitreal injections of Ranibizumab (Lucentis). Following month 2, they will be eligible for re-treatment with Ranibizumab (Lucentis) if retreatment criteria are met (same criteria as study arm 1). At intervals of no less than 3 months from the previous sham PDT, they will receive sham PDT if retreatment criteria are met.

Undersøgelsestype

Interventionel

Fase

  • Ikke anvendelig

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 / Female > 50 years of age
  • FA diagnosis of CNV lesions as described above
  • Have a best corrected visual acuity letter score in the study eye between 72-24 letters (approximately 20/40 to 20/320) using ETDRS chart measured at 4 meters
  • Central retinal (including lesion) thickness greater than or equal to 250 microns as measured by OCT
  • Subretinal hemorrhage making up less than 50% of total lesion size and sparing the fovea
  • Sufficiently clear ocular media including the lens to allow photography of the retina
  • Written informed consent has been obtained.

Exclusion Criteria:

  • Dense subfoveal hemorrhage (>50% of the lesion)
  • Tear or rip of the retina pigment epithelium, idiopathic parafoveal telangiectasis or serous pigment epithelial detachment without CNV
  • Geographic atrophy involving the foveal center
  • Subretinal fibrotic scar in the study eye greater than 25% of the lesion
  • Presence of any condition in study eye other than AMD known to be associated with CNV
  • History diabetic retinopathy or diabetic macular edema
  • Previous pars plana vitrectomy
  • Previous photodynamic therapy in the study eye
  • Previous photodynamic therapy in the fellow eye with resultant choroidal hypoperfusion
  • Previous intravitreal anti-VEGF or steroid injection in the study eye
  • Previous thermal subfoveal laser treatment in study eye
  • Anticipated need for ocular surgery in the study eye during the 13 month study period
  • Known allergy or sensitivity to the study medication(s) its components, diagnostic agents used during the study (Fluorescein, dilation drops) or other agents required for the study procedures (ie: povidone iodine)
  • Porphyria or other porphyrin sensitivity

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1
Reduced fluence (3300mW/cm2-50% standard fluence) PDT + ranibizumab
Medicin: Ranibizumab
Ranibizumab, and reduced fluence PDT or sham PDT and Ranibizumab. For 2 months injected intravitreal Ranibizumab will be given. At month 3 subjects will receive combination reduced fluence PDT and intravitreal Ranibizumab. If they develop recurrence of subretinal fluid, cystoid macular edema, increased pigment epithelial detachment (PED), or increased retinal thickness >100 microns compared to best thickness measure of OCT, subjects will be eligible for repeat combination reduced fluence PDT + intravitreal Ranibizumab every 3 months thereafter.
Andre navne:
  • Lucentis
Aktiv komparator: 2
Ranibizumab monotherapy
Medicin: Ranibizumab monotherapy
3 monthly intravitreal injections of Ranibizumab monotherapy. After month 2 they are eligible for retreatment with Ranibizumab if retreatment criteria are met (same as arm 1) At intervals of no less than 3 months from the previous sham PDT they will receive sham PDT if retreatment criteria are met.
Andre navne:
  • lucentis

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Primary efficacy will be proportion of subjects with best corrected visual acuity improvement of 15 or more letters from baseline and wil visual acuity stabilization, less than 15 letter loss from baseline at 13 months
Tidsramme: at conclusion of subject enrollment
at conclusion of subject enrollment

Sekundære resultatmål

Resultatmål
Tidsramme
Mean change in ETDRS from baseline, number of Ranibizumab treatments w/reduced fluence PDT, proportion of patients with 6 lines of vision loss
Tidsramme: at conclusion of subject enrollment
at conclusion of subject enrollment

Samarbejdspartnere og efterforskere

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

Sponsor

Lahey Clinic

Efterforskere

  • Ledende efterforsker: Jeffrey L Marx, M.D., Lahey Clinic Medical Center

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. december 2006

Primær færdiggørelse (Forventet)

1. juli 2012

Studieafslutning (Forventet)

1. juli 2012

Datoer for studieregistrering

Først indsendt

30. juli 2008

Først indsendt, der opfyldte QC-kriterier

31. juli 2008

Først opslået (Skøn)

1. august 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

10. maj 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. maj 2012

Sidst verificeret

1. maj 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2006-085

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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