Choroidal Neovascularization Clinical Trial
Official title:
Age-related Macular Degeneration: Detection of Onset of New Choroidal Neovascularization (AMD DOC Study)
Verified date | October 2009 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 98 |
Est. completion date | August 2009 |
Est. primary completion date | August 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 50 Years and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | The Wilmer Eye Institute at Johns Hopkins | Baltimore | Maryland |
United States | Retina Associates of Cleveland | Beachwood | Ohio |
United States | Retina Vitreous Associates | Beverly Hills | California |
United States | Ophthalmic Consultants of Boston | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University |
United States,
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