ISRCTN94557601CompletedNot Applicable
The putative beneficial effects of supplemental Lutein (L) and Zeaxanthin (Z) with co-antioxidants in patients with age-related maculopathy: A pilot short term randomised controlled clinical trial of antioxidant supplementatio
Dr. Mann Pharma GmbH, Bausch & Lomb Group (Germany)0 sites360 target enrollmentStarted: July 25, 2005Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 360
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Patient must be willing to give written informed consent, make the required study visits, and follow instructions
- •2. Patient must be at least 50 years of age
- •3. Patients may be of any race or sex
- •4. Two groups of ARM patients may be included
- •Group 1: If there is choroidal neovascularisation (CNV) or geographic atrophy (GA) in one eye, any level of ARM is permissible in the fellow eye provided visual acuity (VA) is equal to or better than logarithm of the minimum angle of resolution (logMAR) 0.3
- •Group 2: Clinical diagnosis of severe early ARM in at least one eye.
- •=20 soft distinct or soft indistinct drusen or if fewer that 20 soft drusen, focal hyper pigmentation must be present.
- •Visual acuity greater than or equal to 6/12 or 0.3 logMAR in the study eye (which may be both eyes).
Exclusion Criteria
- •1. Any retinal laser therapy in the study eye
- •2. In Group 1 there should be no visible choroidal neovascularisation or geographic atrophy
- •3. History of any unstable medical condition or life threatening conditions, for example, cancer or renal failure, that would preclude scheduled study visits or completion of the study
- •4. History of ophthalmic disease in the study eye (other than ARM) that would compromise the visual acuity of the study eye
- •5. Patients currently on supplements containing the antioxidants C, E, Zn, L and Z will be asked to discontinue them and may, after a washout period of three months, be eligible for randomisation into the study
- •6. History of malabsorption
- •7. History of psychiatric disorder, which may interfere with compliance in taking study medication or attendance for study visits
- •8. Patients with known allergy against one of the active ingredients or the other excipients in the study medications
Investigators
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