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Sponsored by: |
Notal Vision Ltd |
Information provided by: | Notal Vision Ltd |
ClinicalTrials.gov Identifier: | NCT00359008 |
The primary objective of this study is to assess the ability of the PHP & HPHP to detect newly diagnosed non treated Chorodial neovascularization (CNV) lesion associate with advanced age related Macular Degeneration (AMD) and differentiate them from Early/intermediate/GA AMD
Condition | Phase |
Age Related Macular Degeneration |
Phase III |
Genetics Home Reference related topics: | X-linked juvenile retinoschisis |
MedlinePlus related topics: | Macular Degeneration |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | PHP Preferential Hyperacuity Perimeter for the Detection of Choroidal Neovascularization (CNV) |
Enrollment: | 336 |
Study Start Date: | July 2006 |
Study Completion Date: | September 2007 |
Groups/Cohorts |
1
Intermediate AMD
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2
New untreated CNV subject
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the study is prospective, multi-center, comparative
The PHP is a class I FDA approved Device ( K050350 )
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
At least 200 subjects with intermediate AMD in at least one (1) eye based on medical record review and/or clinical diagnosis and at least 200 subjects with neovascular AMD in at least one (1) eye in all sites.
Inclusion Criteria:
Newly diagnosed (up to 6 months) non-treated CNV patients secondary to AMD in the study eye, or GA patients or Early and Intermediate AMD patients.
Exclusion Criteria:
Evidence of macular disease other than AMD or Glaucoma in the study eye.
Company Site 
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Responsible Party: | NotalVision ( Osnat Ehrman ) |
Study ID Numbers: | PHP V3 |
First Received: | July 30, 2006 |
Last Updated: | January 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00359008 |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
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