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Age-related Macular Degeneration: Detection of Onset of New Choroidal Neovascularization (AMD DOC Study)

2. oktober 2009 opdateret af: Johns Hopkins University
The purpose of this study is to determine the sensitivity of the optical coherence tomography (OCT) test in detecting neovascular AMD in eyes at high risk for CNV development. In order to test this hypothesis, we are conducting a multi-center clinical study at four participating clinical centers. A total of 227 participants will be enrolled. Participants will be followed-up for a period of two years, or until CNV develops in the study eye for which treatment is recommended, to determine the occurrence of CNV. The fundamental design principles of the study are simplicity and parsimony.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Primary Objective:

The purpose of this study is to determine the sensitivity of the OCT in detecting conversion to neovascular AMD by two years in eyes at high risk for CNV, with FA serving as the gold standard.

Secondary Objectives:

  • To determine the specificity, positive predictive value, and negative predictive value of the OCT in detecting conversion to neovascular AMD by two years in eyes at high risk for CNV, with FA serving as the gold standard.
  • To compare the sensitivity, specificity, positive predictive value, and negative predictive value of the OCT to the PHP or the supervised Amsler Grid in subjects who had either negative PHP and/or negative supervised Amsler grid at baseline for detection of neovascular AMD by two years in eyes at high risk for CNV
  • To describe features of false positives and false negatives with respect to baseline characteristics seen on PHP testing, supervised Amsler grid testing, and OCT imaging
  • To describe the relationship between new visual symptoms experienced by participants prompting an interim evaluation where treatment for CNV was recommended and findings seen at the previous study visit (PHP testing, supervised Amsler grid testing, OCT imaging, other findings on exam, or fluorescein angiography) as well as findings from the baseline visit
  • To determine the physician's detection of CNV development on return study visits including slit lamp biomicroscopy before viewing ancillary tests from that visit (supervised Amsler grid, PHP, OCT, fundus photographs, fluorescein angiogram)

All participants will be examined upon enrollment and then followed every three months after enrollment for two years or until conversion to CNV is positive and treatment is recommended. Specifically, follow-up visits will occur at 3, 6, 9, 12, 15, 18, 21, and 24 months from the date of the Initial Visit.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

98

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • California
      • Beverly Hills, California, Forenede Stater, 90211
        • Retina Vitreous Associates
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21287
        • The Wilmer Eye Institute at Johns Hopkins
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Ophthalmic Consultants of Boston
    • Ohio
      • Beachwood, 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

50 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Participants will have neovascular AMD in the fellow eye and non-neovascular AMD in the candidate study eye to be eligible for this study. Additional inclusion and exclusion criteria are listed below.

Beskrivelse

Inclusion Criteria:

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study
  • Age 50 years or greater
  • Best corrected visual acuity letter score = 65 or greater (approximate Snellen equivalent of 20/50 or better in the candidate study eye)
  • Neovascular AMD in the fellow eye and no CNV in the candidate study eye (absence of CNV confirmed by FA which will be graded in a masked fashion by the AMD DOC Study Reading Center)
  • Candidate study eye must have evidence of at least one large druse (≥ 125µm) and focal hyperpigmentation within 3600μm of the fovea and visible on color fundus photography, red-free photograph, or fluorescein angiography
  • Participant must have media clear enough in the candidate study eye to permit fundus photography, fluorescein angiography, and optical coherence tomography and absence of any fluorescein allergies
  • Results of the baseline PHP and supervised Amsler grid will not affect eligibility of the participant. Subjects can be eligible for further follow-up even if they have positive PHP and Amsler grid
  • Eligible participants who have a positive PHP or supervised Amsler grid for that eye at the initial screening visit should have a second PHP or supervised Amsler grid screening visit within 2 weeks in order to repeat the PHP or Amsler test or the participant may repeat the PHP or Amsler grid that day before pupillary dilation. Participants with a 2nd positive PHP or supervised Amsler grid are still eligible for further follow-up
  • All tests (supervised Amsler grid, PHP, OCT, FA) must be performed within 2 weeks of each other
  • Participants with non-foveal geographic atrophy in the candidate study eye are still eligible for enrollment in the study

Exclusion Criteria:

  • Known allergy to fluorescein angiography or allergic reaction during screening
  • Advanced AMD with CNV in both eyes confirmed on FA graded by the AMD DOC Study Reading Center
  • Foveal geographic atrophy in the study eye
  • Positive OCT test for the candidate study eye, as read by the AMD DOC Study Reading Center, for subretinal fluid, intraretinal edema, or retinal thickening that falls within the top 1% of the normative data base for the Stratus OCT
  • Significant media opacity that precludes reasonable quality retinal imaging including color fundus photographs, fluorescein angiography, or OCT in the candidate study eye to assess the presence of CNV
  • Evidence of macular disease (e.g., pattern dystrophy, diabetic macular edema, vitreomacular traction) other than AMD in the study eye
  • Previous surgical or laser treatment to the macula of the study eye
  • Diabetic retinopathy

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Samarbejdspartnere og efterforskere

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

Sponsor

Johns Hopkins University

Efterforskere

  • Studiestol: Diana V. Do, M.D., Johns Hopkins Medical Institutes
  • Studieleder: Neil M. Bressler, M.D., Johns Hopkins Medical Institutes

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 2007

Primær færdiggørelse (Faktiske)

1. august 2009

Studieafslutning (Faktiske)

1. august 2009

Datoer for studieregistrering

Først indsendt

3. januar 2007

Først indsendt, der opfyldte QC-kriterier

3. januar 2007

Først opslået (Skøn)

4. januar 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

5. oktober 2009

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. oktober 2009

Sidst verificeret

1. oktober 2009

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NA_00006147

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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