Antioxidant Systems and Age-Related Macular Degeneration
Keywords
Abstract
Description
Inclusion Criteria
- Age 55-80
- 70 Participants with Intermediate or Advanced AMD
- 70 participants with no ocular signs of AMD
- Willing to give written informed consent, make the required study visits, and follow instructions
- Any race and either sex
Exclusion Criteria
- Current history of a medical condition that would preclude scheduled study visits or completion of the study (e.g., unstable cardiovascular disease, unstable pulmonary disease, chronic hepatitis, or AIDS).
- Current or history of an ophthalmic disease in the study eye (other than AMD) that would likely compromise or during follow-up could likely compromise the visual acuity of the study eye (e.g., amblyopia, uncontrolled glaucoma with an IOP > 30mmHg, ischemic optic neuropathy, proliferative diabetic retinopathy, clinically relevant nonproliferative diabetic retinopathy, clinically relevant diabetic macular edema, significant active uveitis).
- Clinical signs of myopic retinopathy, or a refraction of > -8 diopter power in current prescription
- Aphakic or psuedophakic patients may be enrolled if there is no funduscopic evidence of degenerative myopia present and if there is no medical history prior to the patient's cataract surgery of either myopic retinopathy or a refraction of > -8 diopters.
- Intraocular surgery in study eye (eye to be treated) within 60 days prior to enrollment
- Presence of a scleral buckle in the study eye
- Currently participating or has participated in a clinical trial that utilized an investigational drug or treatment within 30 days prior to administration of study medication. Daily vitamins and/or mineral therapy are allowed.
- Known medical history of allergy or sensitivity to any component of the drug formulation and/or fluorescein dye that is clinically significant in the investigator's opinion.
- Patient is on oral anticoagulant therapy of Coumadin
Dates
| Last Verified: | 12/31/2013 |
| First Submitted: | 04/23/2008 |
| Estimated Enrollment Submitted: | 04/27/2008 |
| First Posted: | 04/28/2008 |
| Last Update Submitted: | 01/07/2014 |
| Last Update Posted: | 01/09/2014 |
| Actual Study Start Date: | 05/31/2006 |
| Estimated Primary Completion Date: | 05/31/2010 |
| Estimated Study Completion Date: | 05/31/2010 |
Condition or disease
Phase
Eligibility Criteria
| Ages Eligible for Study | 55 Years To 55 Years |
| Sexes Eligible for Study | All |
| Sampling method | Probability Sample |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - Age 55-80 - 70 Participants with Intermediate or Advanced AMD - 70 participants with no ocular signs of AMD - Willing to give written informed consent, make the required study visits, and follow instructions - Any race and either sex Exclusion Criteria: - Current history of a medical condition that would preclude scheduled study visits or completion of the study (e.g., unstable cardiovascular disease, unstable pulmonary disease, chronic hepatitis, or AIDS). - Current or history of an ophthalmic disease in the study eye (other than AMD) that would likely compromise or during follow-up could likely compromise the visual acuity of the study eye (e.g., amblyopia, uncontrolled glaucoma with an IOP > 30mmHg, ischemic optic neuropathy, proliferative diabetic retinopathy, clinically relevant nonproliferative diabetic retinopathy, clinically relevant diabetic macular edema, significant active uveitis). - Clinical signs of myopic retinopathy, or a refraction of > -8 diopter power in current prescription - Aphakic or psuedophakic patients may be enrolled if there is no funduscopic evidence of degenerative myopia present and if there is no medical history prior to the patient's cataract surgery of either myopic retinopathy or a refraction of > -8 diopters. - Intraocular surgery in study eye (eye to be treated) within 60 days prior to enrollment - Presence of a scleral buckle in the study eye - Currently participating or has participated in a clinical trial that utilized an investigational drug or treatment within 30 days prior to administration of study medication. Daily vitamins and/or mineral therapy are allowed. - Known medical history of allergy or sensitivity to any component of the drug formulation and/or fluorescein dye that is clinically significant in the investigator's opinion. - Patient is on oral anticoagulant therapy of Coumadin |
Outcome
Primary Outcome Measures
1. The purpose of this study is to find out if there are changes in the blood that would make you at risk for having age related macular degeneration. [5 years]
