A multi-site trial of a novel nutritional supplement (taurine, omega-3 fatty acids, zinc, antioxidants, and lutein) and micro-current stimulation in the treatment of atrophic (dry) age-related macular degeneratio

Completed

• Conditions: Atrophic (dry) age-related macular degeneration; Eye Diseases; Macular degeneration

• Registration Number: ISRCTN57556290
• Lead Sponsor: Atlantic Medical, Inc. (USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-28
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

1. Signed written consent
2. Between the ages of 50 and 90, inclusive
3. Any race or gender
4. Diagnosis of nonexudative (dry) Age-related Macular Degeneration (AMD) in at least one eye having more than ten large soft drusen 63 um in diameter, within 3,000 um of the fovea centre, documented on macular exam, retinal angiography and fundus photographs
5. Able to understand and comply with the requirements of the trial
6. Best Corrected Visual Acuity (BCVA) in the trial eye(s) of 20/32 to 20/125 inclusive as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) (logMAR)
7. Subjects must not have conditions that limit the view to the fundus (e.g. vitreous haemorrhage, cataracts, an epiretinal membrane). All subjects with more than or equal to 2+ nuclear opacities and/or significant central opacity (Posterior SubCapsular opacity [PSC] or Anterior SubCapsular opacity [ASC]) more than 1+ will undergo Potential Acuity Meter (PAM) testing. If the vision is more than or equal to two lines improved on PAM over standard acuity measurement then the subject will not be eligible for the trial
8. Subjects must be available for a minimum trial duration of approximately six months
9. Subjects must agree to take only the nutritional supplement that is provided during this study
10. Subjects or eyes must not meet any of the exclusion criteria

Exclusion Criteria

Any of the following excluded a subject from the trial:
1. Currently enrolled in an ophthalmic clinical trial
2. Eyes with concomitant macular or choroidal disorders other than AMD and with indefinite signs of AMD
3. Eyes with a diagnosis of exudative (wet) AMD with active SubRetinal NeoVascularisation (SRNV) or Choroidal NeoVascularisation (CNV) lesions requiring laser photocoagulation in the study eye
4. Subjects with significant ocular lens opacities causing vision decrease
5. Subjects with amblyopia
6. Subjects with optic nerve disease (neuropathy, atrophy, papilledema), unstable glaucoma as defined by intraocular pressures greater than 25 mmHg, three 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
7. Subjects with demand type pacemakers or epilepsy
8. Subjects with uncontrolled hypertension (defined as diastolic of 90 or greater and systolic of 150 or greater)
9. Subjects with recent history (within the previous year) of cerebral vascular disease manifested with Transient Ischaemic Attacks (TIA?s) or cerebral vascular accidents (CVA?s)
10. Subjects with a history of Acquired Immune Deficiency Syndrome (AIDS)
11. 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
12. Subjects who have had intraocular surgery in trial eye within three months prior to enrolling in the trial
13. Smokers or any tobacco use

Study & Design

• Study Type: Interventional
• Study Design: Not specified