Ignite Creation Date:
2024-05-06 @ 12:15 AM
Last Modification Date:
2024-10-26 @ 10:47 AM
Study NCT ID:
NCT01527435
Status:
COMPLETED
Last Update Posted:
2016-04-06
First Post:
2012-01-27
Brief Title:
Addition of 20mgDay Zeaxanthin to Triple Therapy Treatment Options for Age Related Macular Degeneration ARMD
Sponsor:
The Retina Center of St Louis County PC
Organization:
The Retina Center of St Louis County PC
Study Overview
Official Title:
Zeaxanthin as an Adjuvant to Combination Therapy for Treatment of Choroidal Neovascularization CNV in Exudative Age Related Macular Degeneration ARMD
Status:
COMPLETED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARMD
Brief Summary:
The purpose of this study is to evaluate the fact that 20 milligrams per day of oral Zeaxanthin as a supplement to patients with Choroidal neovascularization CNV and exudative age related macular degeneration ARMD undergoing combination therapy with intravitreal Bevacizumab Avastin intravitreal Dexamethasone and PDT laser photocoagulation and improves anatomic and visual outcome compared to patients not receiving oral Zeaxanthin Study patients will be taking AREDSPreserVision and multivitamins Centrum Silver in addition one-half of the patients will receive 20mg of oral Zeaxanthin
Detailed Description:
One of the current treatments for choroidal neovascularization in exudative age related macular degeneration ARMD involves a combination of laser photocoagulation PDT and injections of an anti-inflammatory Dexamethasone and an anti-angiogenic Bevacizumab This combination therapy is designed to stabilize vision improve vision in selected cases and reduce the total number of treatment cycles overall compared to other methods of treatment presently in use Many retinal physicians are treating exudative ARMD with an ocular injection every 4 weeks for a number of years Combination therapy has reduced the number of treatment cycles to less than 3 for many patients and in preliminary studies patients taking 20 milligrams of dietary oral zeaxanthin required even less treatment cycles to achieve stability In this trial the only variable will be the oral consumption of 20 milligrams of zeaxanthin daily taken in half of the patients randomized to this group The remaining half patients with still undergo combination therapy but without taking 20 milligrams of oral dietary Zeaxanthin
Zeazanthin is found in many foods and low doses of zeazanthin are commonly added to many multivitamins already on the market All products with Zeazanthin is a constituent including EyePromise Ten have excellent safety profiles and no side effects or adverse events have been reported thus far with this supplement
Zeazanthin is in many eye supplements and is being studied by the NEI National Eye Institute as part of the AREDS-2 study looking at the benefits of Lutein Zeazanthin and Omega 3 Fish Oils on AMD progression The patients will be taking 20 milligrams a day of Zeazanthin The United States and global safety organization have established an ADI acceptable daily intake of 2 mgkg body weightday of Zeazanthin This equates to 155 mg per day for 177 pound person
Millions of doses of EyePromise Ten have been taken without side effects The new part of this trial again is taking 20 milligrams of Zeazanthin while being combined with medical injections and laser treatments Zeazanthin is one of the two pigments obtained from the diet that deposit in the macula and give it the yellow color While obtained from the diet the retina accumulates it up to 1000 times higher levels than anywhere else in the body Numerous scientific and clinical trials suggest that it is critical to the protection of the retina and in reducing risks and progression of age related macular degeneration
Zeazanthin is found in many foods and low doses of zeazanthin are commonly added to many multivitamins already on the market All products with Zeazanthin is a constituent including EyePromise Ten have excellent safety profiles and no side effects or adverse events have been reported thus far with this supplement
Zeazanthin is in many eye supplements and is being studied by the NEI National Eye Institute as part of the AREDS-2 study looking at the benefits of Lutein Zeazanthin and Omega 3 Fish Oils on AMD progression The patients will be taking 20 milligrams a day of Zeazanthin The United States and global safety organization have established an ADI acceptable daily intake of 2 mgkg body weightday of Zeazanthin This equates to 155 mg per day for 177 pound person
Millions of doses of EyePromise Ten have been taken without side effects The new part of this trial again is taking 20 milligrams of Zeazanthin while being combined with medical injections and laser treatments Zeazanthin is one of the two pigments obtained from the diet that deposit in the macula and give it the yellow color While obtained from the diet the retina accumulates it up to 1000 times higher levels than anywhere else in the body Numerous scientific and clinical trials suggest that it is critical to the protection of the retina and in reducing risks and progression of age related macular degeneration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None