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

2. oktober 2009 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Detaljert 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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

98

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • California
      • Beverly Hills, California, Forente stater, 90211
        • Retina Vitreous Associates
    • Maryland
      • Baltimore, Maryland, Forente stater, 21287
        • The Wilmer Eye Institute at Johns Hopkins
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02114
        • Ophthalmic Consultants of Boston
    • Ohio
      • Beachwood, Ohio, Forente stater, 44122
        • Retina Associates of Cleveland

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

50 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Johns Hopkins University

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2007

Primær fullføring (Faktiske)

1. august 2009

Studiet fullført (Faktiske)

1. august 2009

Datoer for studieregistrering

Først innsendt

3. januar 2007

Først innsendt som oppfylte QC-kriteriene

3. januar 2007

Først lagt ut (Anslag)

4. januar 2007

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

5. oktober 2009

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. oktober 2009

Sist bekreftet

1. oktober 2009

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NA_00006147

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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