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Safety and Efficacy Study of Small Interfering RNA Molecule (Cand5) to Treat Diabetic Macular Edema

24. juli 2008 opdateret af: OPKO Health, Inc.

A Phase II, Pharmacokinetic, Randomized, Double-Masked, Controlled, Dose Comparison Study of Cand5 for Intravitreal Injection for the Treatment of Diabetic Macular Edema

The purpose of this study is to evaluate the pharmacokinetics, safety and preliminary efficacy of 3 doses of Cand5. Cand5 is a small interfering RNA molecule that selectively silences the mRNA encoding for VEGF. The target population are patients with diabetic macular edema.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Diabetic retinopathy is the leading cause of newly diagnosed blindness in the working age (20-74) population in the United States1 and diabetic macular edema (DME) is the leading cause of vision loss in diabetic retinopathy. DME is the result of the breakdown of the retinal capillary endothelium in patients with diabetes mellitus (Type I and II).

A key factor in the development of DME is the permeability of the blood-retinal barrier. The breakdown of the endothelial tight junctions of the capillary walls in the retinal vasculature leads to increased permeation of salts, proteins, and water from the capillary luminal side of the barrier and the accumulation of fluid in the extracellular space. Multiple agents appear to contribute to the disruption of the blood-retina barrier,including vasoactive agents, prostaglandin and vascular endothelial growth factor (VEGF). VEGF is a peptide that promotes neovascularization and increases vascular permeability. If the resulting fluid is more than the amount that can be removed through the active pump mechanism (retinal pigmented epithelium), fluids continue to accumulate and edema develops. When thickening evolves or threatens the center of the fovea there is a high risk of visual loss.

Cand5 is a synthetic double stranded RNA (dsRNA) oligonucleotide. The molecule is a duplex formed by the hybridization of two partially complementary single strand RNAs in which the 3' end are capped with 2 deoxyribose (dT) units. Hybridization occurs across 19 ribose base pairs to yield the Cand5 molecule. Cand5 has a molecular weight of 13,345 grams/mole. Cand5 selectively silences the mRNA encoding for VEGF.

A comparison will be made between the three (3) treatment arms with regard to safety, efficacy, and duration of effect to determine a safe and efficacious dose of Cand5 appropriate for evaluation in future pivotal trials.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

48

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
    • Ohio
      • Beechwood, Ohio, Forenede Stater, 44122
        • Retina Associates of Cleveland

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

21 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Patients must be male or female age 21 or older.
  2. Patient must sign (and be given) a copy of the written informed consent form.

  3. Patients must have the diagnosis of diabetes mellitus (type 1 or type 2). Patients with the following will be considered to be sufficient evidence that diabetes is present:

    • Current regular use of insulin for the treatment of diabetes mellitus OR
    • Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes OR
    • Documented diabetes by WHO criteria
  4. Patients must have ETDRS best corrected visual acuity of 69 to 24 letters (20/40 to 20/320 Snellen Equivalent) in the study eye.
  5. Patients must have a mean retinal thickness on OCT ≥ 250 microns in the central subfield.

Exclusion Criteria:

  1. Patients with a history of chronic renal failure requiring dialysis or kidney transplant.

  2. 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), including:

    • Patients in poor glycemic control who, within the last 4 months, initiated intensive insulin treatment (a pump or multiple daily injections) or plan to do so in the next 4 months should not be enrolled.
    • Patients with HbA1C > 10%OR
    • Patients with systolic blood pressure greater than 170 mmHg and/or diastolic blood pressure greater than 100 mmHg (Note: If blood pressure is brought below 170/100 mmHg by anti-hypertensive treatment, patient can become eligible).
  3. Past panretinal photocoagulation (PRP) for diabetes within 12 weeks of screening or PRP expected to be needed in the next three months in the study eye.
  4. Focal laser therapy to the retina of the study eye within 12 weeks of screening.
  5. Any intraocular surgery or ocular laser procedures in the study eye within 12 weeks of screening.
  6. Participation in an investigational trial within 30 days of study entry that involved treatment with any drug that has not received regulatory approval at the time of study entry.

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: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 1
3.0 mg/eye dose group
Medicin: bevasiranib
Andre navne:
  • Cand5
Eksperimentel: 2
1.5 mg/eye dose group
Medicin: bevasiranib
Andre navne:
  • Cand5
Eksperimentel: 3
0.2 mg/eye dose group
Medicin: bevasiranib
Andre navne:
  • Cand5

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Change from baseline at the 12-week evaluation in macular edema as measured by optical coherence tomography.

Sekundære resultatmål

Resultatmål
Mean BCVA line/letters change from baseline at the 12-week evaluation.

Samarbejdspartnere og efterforskere

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

Sponsor

OPKO Health, Inc.

Efterforskere

  • Studieleder: Christine Du Castel, MD, Chiltern International

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. januar 2006

Primær færdiggørelse (Faktiske)

1. september 2007

Studieafslutning (Faktiske)

1. december 2007

Datoer for studieregistrering

Først indsendt

23. marts 2006

Først indsendt, der opfyldte QC-kriterier

23. marts 2006

Først opslået (Skøn)

27. marts 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

25. juli 2008

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. juli 2008

Sidst verificeret

1. juli 2008

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ACU211

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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