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Pilot Study for the Evaluation of Intravitreal Infliximab in the Treatment of Uveitic Macular Edema

21. juni 2011 opdateret af: Icahn School of Medicine at Mount Sinai
The purpose of this study is to determine if intravitreal infliximab is a safe and effective treatment for macular edema secondary to uveitis.

Studieoversigt

Detaljeret beskrivelse

Participants with uveitic macular edema will be treated with one injection of intravitreal infliximab (2.0mg/0.05ml) and followed for three months. Outcomes that be assessed include best-corrected visual acuity, macular thickness as measured by optical coherence tomography, and electroretinogram responses.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

10

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

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

Studiesteder

    • New York
      • New York, New York, Forenede Stater, 10029
        • Department of Ophthalmology, Mount Sinai School of Medicine

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:

  1. Participant must be 18 years of age or older.
  2. Participant must understand and sign the protocol's informed consent document.
  3. Participants must have uveitic macular edema in one eye as defined by all of the following criteria:

    1. Presence of active intermediate uveitis or posterior uveitis.
    2. Macular edema defined as a central macular thickness of ≥ 250 μm on OCT.
    3. Uveitis must be noninfectious as determined by standard investigations used in the diagnostic investigation of uveitis.
  4. Participant must have visual acuity between 20/40 and hand motions in the study eye.
  5. Participant must have a steady fixation in the study eye and media clear enough for good quality imaging.
  6. Female participants of childbearing potential must not be pregnant or breast-feeding, must have a negative pregnancy test at screening and must practice an adequate method of birth control. Males able to father a child must agree to practice birth control. Acceptable methods of birth control include hormonal contraception (birth control pills, injected hormones or vaginal ring), intrauterine device, barrier methods with spermicide (diaphragm with spermicide, condom and spermicide) or surgical sterilization (hysterectomy, tubal ligation or vasectomy in a partner). If a participant is of childbearing potential, she must be willing to undergo monthly urine pregnancy tests. Both males and females must agree to use adequate birth control for three months after the intravitreal infliximab injection.

Exclusion Criteria:

  1. Participant is in another investigational study and actively receiving study therapy.
  2. Participant is unable to comply with study procedures or follow-up visits.
  3. Participant has uveitic macular edema (as defined above) in both eyes.
  4. Participant has multiple sclerosis or symptoms suggestive of multiple sclerosis.
  5. Participant has evidence of ocular disease other than uveitis in either eye that may confound the outcome of the study (e.g., diabetic retinopathy, age-related macular degeneration, vitreomacular traction, moderate/severe myopia, etc.).
  6. Participant is expected to need ocular surgery in the study eye during the course of the study.
  7. Participant has undergone ocular surgery or an intravitreal/periocular steroid injection in the study eye within the past 3 months.
  8. Participant has had a YAG laser capsulotomy or intravitreal anti-VEGF treatment in the study eye within the past 6 weeks.
  9. Participant has had a pars plana vitrectomy in the study eye.
  10. Participant is on ocular or systemic medications known to be toxic to the lens, retina, or optic nerve.
  11. Participant with a history of ocular herpes simplex virus infection in the study eye.
  12. A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control).
  13. There are no criteria for inclusion/exclusion for the fellow eye. Only one eye can have macular edema in order for the potential participant to be considered for enrollment.

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intravitreal infliximab
Én injektion af intravitreal infliximab (2,0 mg/0,05 ml).
Andre navne:
  • Remicade™

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Bedst korrigeret synsstyrke
Tidsramme: Tre måneder
Tre måneder

Sekundære resultatmål

Resultatmål
Tidsramme
Makula tykkelse
Tidsramme: En, to og tre måneder
En, to og tre måneder

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Farzin Forooghian, MD, Icahn School of Medicine at Mount Sinai

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.

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. august 2009

Studieafslutning (Faktiske)

1. oktober 2009

Datoer for studieregistrering

Først indsendt

11. august 2009

Først indsendt, der opfyldte QC-kriterier

12. august 2009

Først opslået (Skøn)

13. august 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

23. juni 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. juni 2011

Sidst verificeret

1. juni 2011

Mere information

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 Uveitisk makulært ødem

Kliniske forsøg med Infliximab (intravitreal, 2,0 mg/0,05 ml)

Abonner