Addition of 20mg/Day Zeaxanthin to Triple Therapy Treatment Options for Age Related Macular Degeneration (ARMD) (ARMD)
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|ClinicalTrials.gov Identifier: NCT01527435|
Recruitment Status : Completed
First Posted : February 7, 2012
Last Update Posted : April 6, 2016
|Condition or disease|
|Exudative Age-Related Macular Degeneration|
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 mg/kg body weight/day 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 Type :||Observational|
|Actual Enrollment :||200 participants|
|Observational Model:||Case Control|
|Official Title:||Zeaxanthin as an Adjuvant to Combination Therapy for Treatment of Choroidal Neovascularization (CNV) in Exudative Age Related Macular Degeneration (ARMD)|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
- BEST CORRECTED VISUAL ACUITY AFTER TREATMENTS [ Time Frame: 3, 6 12, 15, 18 AND 24 MONTHS AFTER ENTRY ]BEST CORRECTED VISUAL ACUITY AFTER TREATMENTS WITH THOSE ON SUPPLEMENTS VERSUS BEST CORRECTED VISUAL ACUITY OF THOSE WHO JUST RECEIVED TREATMENTS
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01527435
|United States, Missouri|
|The Retina Center|
|St. Louis, Missouri, United States, 63141|
|Principal Investigator:||Robert J Olk, MD||The Retina Center|