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

2 oktober 2009 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Gedetailleerde beschrijving

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

Observationeel

Inschrijving (Werkelijk)

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

50 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Johns Hopkins University

Onderzoekers

Studie stoel: Diana V. Do, M.D., Johns Hopkins Medical Institutes
Studie directeur: Neil M. Bressler, M.D., Johns Hopkins Medical Institutes

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 januari 2007

Primaire voltooiing (Werkelijk)

1 augustus 2009

Studie voltooiing (Werkelijk)

1 augustus 2009

Studieregistratiedata

Eerst ingediend

3 januari 2007

Eerst ingediend dat voldeed aan de QC-criteria

3 januari 2007

Eerst geplaatst (Schatting)

4 januari 2007

Updates van studierecords

Laatste update geplaatst (Schatting)

5 oktober 2009

Laatste update ingediend die voldeed aan QC-criteria

2 oktober 2009

Laatst geverifieerd

1 oktober 2009

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

NA_00006147

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