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

NCT00417846 | Completed DMC

• 1 other identifier: NA_00006147
• Study Type: observational
• Target: 98
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Maculopathy, Age-Related; Choroidal Neovascularization

Keywords

Age-Related Macular Degeneration; Optical Coherence Tomography, OCT; Preferential Hyperacuity Perimeter, PHP; Amsler Grid

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (4)

Retina Vitreous Associates

Beverly Hills, California, 90211, United States

Location

The Wilmer Eye Institute at Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

Retina Associates of Cleveland

Beachwood, Ohio, 44122, United States

Location

MeSH Terms

Conditions

Macular Degeneration; Choroidal Neovascularization; Ornithine Carbamoyltransferase Deficiency Disease

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Choroid Diseases; Uveal Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urea Cycle Disorders, Inborn; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Diana V. Do, M.D.

  Johns Hopkins Medical Institutes

  STUDY CHAIR

• Neil M. Bressler, M.D.

  Johns Hopkins Medical Institutes

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 3, 2007
• First Posted: January 4, 2007
• Study Start: January 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: October 5, 2009

Record last verified: 2009-10

Locations

US (4)