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Dosing Study of Ranibizumab for Diabetic Retinal and Macular Edema

23. april 2019 opdateret af: Retina Vitreous Associates of Florida

Monthly Ranibizumab Versus Treat and Extend Ranibizumab for Diabetic Macular Edema

This study is to see whether treating diabetic retinal swelling with ranibizumab injections into the eye monthly is better than treating diabetic retinal swelling with ranibizumab injections into the eye less frequently.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a prospective randomized study comparing two groups of patients with diabetic macular edema. One group will receive injections of ranibizumab monthly and the other group will have the option to receive injections of ranibizumab less frequently. That is eligible to receive the injections less frequently will have fewer injections given if the patients in that group are doing well.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

20

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Florida
      • Clearwater, Florida, Forenede Stater, 33756
        • Retina Vitreous Associates of Florida
      • Saint Petersburg, Florida, Forenede Stater, 33711
        • Retina Vitreous Associates of Florida

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

Beskrivelse

Inclusion Criteria:

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Age > 18 years
  • Patient related considerations
  • Phakic or pseudophakic patients with a known history of diabetes will be eligible.
  • Women of reproductive age will be required to take a urine pregnancy test prior to administration of the study drug.
  • Disease related considerations:
  • Patients will have met standard, accepted diagnostic criteria for diabetes and will be currently treated with at least one systemic antihyperglycemic or insulin medication.
  • Patients will have a BCVA ETDRS Snellen-equivalent less than or equal to 20/40
  • Central foveal thickness on SD-OCT of >300um

Exclusion Criteria:

  • Pregnancy (positive pregnancy test) or lactation Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
  • Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
  • Participation in another simultaneous medical investigation or trial
  • Foveal ischemia on IVFA
  • Intraocular surgery less than 6 months ago
  • Epiretinal membrane of clinical significance
  • Prior vitrectomy
  • Uncontrolled glaucoma
  • Macular or peripheral laser within 90 Days from Day 0 injection
  • Intravitreal steroid injection within 90 days from Day 0 injection
  • Intravitreal or systemic anti-VEGF within 30 days from Day 0 injection

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: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Monthly Ranibizumab
Patients randomized to the Monthly Ranibizumab arm of the study will be administered intravitreal injections each month for their diabetic macular edema for the duration of the study.
Medicin: Ranibizumab
Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.
Andre navne:
  • Lucentis
Eksperimentel: Treat and Extend Ranibizumab
Patients randomized to this arm of the study will receive intravitreal injections of ranibizumab until their maculae are anatomically "dry," at which point the evaluation and injection interval will be extended.
Medicin: Ranibizumab
Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.
Andre navne:
  • Lucentis

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Change in Early Treatment for Diabetic Retinopathy Study (ETDRS) Eye Chart Vision.
Tidsramme: Baseline through 24 months
The ETDRS eye chart was used to assess vision at each visit, with the change through month 24 reported.
Baseline through 24 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Number of Injections.
Tidsramme: 24 months
The average number of intravitreal ranibizumab injections in each arm of the study will be recorded.
24 months
Mean Change in Spectral Domain Optical Coherence Tomography (SD-OCT) Central Foveal Thickness (CFT).
Tidsramme: 24 months
Evaluate the average change in the swelling from diabetic macular edema measured with the optical coherence tomography machine.
24 months
Percentage of Patients With Best Corrected Visual Acuity (BCVA) Snellen-equivalent of 20/40 or Better.
Tidsramme: 24 months
The percentage of patients with 20/40 vision as assessed by the number of letters read correctly on the ETDRS eye chart at a starting test distance of 20 feet.
24 months
Percentage of Patients Anatomically "Dry."
Tidsramme: 24 Months
Spectral domain OCT will be used to check the patients' central foveal thickness at each visit and the percentage with "dry" maculas at months 3,6, and 12 based on spectral domain OCT measurements per the study protocol will be recorded.
24 Months

Samarbejdspartnere og efterforskere

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

Sponsor

Retina Vitreous Associates of Florida

Samarbejdspartnere

Genentech, Inc.

Efterforskere

  • Ledende efterforsker: David Eichenbaum, MD, Retina Vitreous Associates of Florida

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.

Hjælpsomme links

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. november 2011

Primær færdiggørelse (Faktiske)

1. september 2016

Studieafslutning (Faktiske)

1. september 2016

Datoer for studieregistrering

Først indsendt

13. november 2011

Først indsendt, der opfyldte QC-kriterier

17. november 2011

Først opslået (Skøn)

22. november 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. maj 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. april 2019

Sidst verificeret

1. april 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1127228

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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