Age-related Macular Degeneration: Detection of Onset of New Choroidal Neovascularization (AMD DOC Study)
2 de outubro de 2009 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Descrição detalhada
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.
Tipo de estudo
Observacional
Inscrição (Real)
98
Contactos e Locais
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Locais de estudo
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California
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Beverly Hills, California, Estados Unidos, 90211
- Retina Vitreous Associates
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Maryland
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Baltimore, Maryland, Estados Unidos, 21287
- The Wilmer Eye Institute at Johns Hopkins
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02114
- Ophthalmic Consultants of Boston
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Ohio
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Beachwood, Ohio, Estados Unidos, 44122
- Retina Associates of Cleveland
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
50 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
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.
Descrição
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
Plano de estudo
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Como o estudo é projetado?
Detalhes do projeto
Colaboradores e Investigadores
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Patrocinador
Investigadores
- Cadeira de estudo: Diana V. Do, M.D., Johns Hopkins Medical Institutes
- Diretor de estudo: Neil M. Bressler, M.D., Johns Hopkins Medical Institutes
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de janeiro de 2007
Conclusão Primária (Real)
1 de agosto de 2009
Conclusão do estudo (Real)
1 de agosto de 2009
Datas de inscrição no estudo
Enviado pela primeira vez
3 de janeiro de 2007
Enviado pela primeira vez que atendeu aos critérios de CQ
3 de janeiro de 2007
Primeira postagem (Estimativa)
4 de janeiro de 2007
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
5 de outubro de 2009
Última atualização enviada que atendeu aos critérios de controle de qualidade
2 de outubro de 2009
Última verificação
1 de outubro de 2009
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- NA_00006147
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