|
Inclusion and exclusion criteria |
| Inclusion Criteria |
| • Signed written consent • Between the ages of 50 and 90, inclusive • Any race or gender • Diagnosis of nonexudative (dry) AMD in at least 1 eye having > 10 large soft drusen 63 μm in diameter, within 3,000 um of the fovea center, documented on macular exam, retinal angiography and fundus photographs • Able to understand and comply with the requirements of the trial • BCVA in the trial eye(s) of 20/32 to 20/125 inclusive as measured by ETDRS (logMAR) • Subjects must not have conditions that limit the view to the fundus (eg vitreous hemorrhage, cataracts, an epiretinal membrane). All subjects with = 2+ nuclear opacities and/or significant central opacity (PSC or ASC) > 1+ will undergo Potential Acuity Meter (PAM) testing. If the vision is = 2 lines improved on PAM over standard acuity measurement then the subject will not be eligible for the trial • Subjects must be available for a minimum trial duration of approximately 6 months • Subjects must agree to take only the nutritional supplement that is provided during this study • Subjects or eyes must not meet any of the exclusion criteria |
| Exclusion Criteria |
| Any of the following excluded a subject from the trial: • Currently enrolled in an ophthalmic clinical trial • Eyes with concomitant macular or choroidal disorders other than AMD and with indefinite signs of AMD • Eyes with a diagnosis of exudative (wet) AMD with active subretinal neovascularization (SRNV) or CNV lesions requiring laser photocoagulation in the study eye • Subjects with significant ocular lens opacities causing vision decrease • Subjects with amblyopia • Subjects with optic nerve disease (neuropathy, atrophy, papilledema), unstable glaucoma as defined by intraocular pressures greater than 25 mm Hg, 3 or more glaucoma medications, C/D of 0.8 or greater and visual fields consistent with glaucoma; history of retina-vitreous surgery, degenerative myopia, active posterior intraocular inflammatory disease, chronic use of topical ocular steroid medications, vasoproliferative retinopathies (other than AMD), rhegmatogenous retinal detachment, and inherited macular dystrophies • Subjects with demand type pacemakers or epilepsy • Subjects with uncontrolled hypertension (defined as diastolic of 90 or greater and systolic of 150 or greater) • Subjects with recent history (within the previous year) of cerebral vascular disease • manifested with transient ischemic attacks (TIA's) or cerebral vascular accidents (CVA's) • Subjects with a history of AIDS • Subjects who have received any previous experimental procedure in either eye or the use of any investigational drug or treatment within 30 days prior to enrolling in the trial • Subjects who have had intraocular surgery in trial eye within 3 months prior to enrolling in the trial • Smokers or any tobacco use |
Cangemi BMC Ophthalmology 2007 7:3 doi:10.1186/1471-2415-7-3 |