Addition of 20mg/Day Zeaxanthin to Triple Therapy Treatment Options for Age Related Macular Degeneration (ARMD)
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 AREDS(PreserVision) and multivitamins (Centrum Silver); in addition one-half of the patients will receive 20mg of oral Zeaxanthin.
Exudative Age-Related Macular Degeneration
|Study Design:||Observational Model: Case Control
Time Perspective: Retrospective
|Official Title:||Zeaxanthin as an Adjuvant to Combination Therapy for Treatment of Choroidal Neovascularization (CNV) in Exudative Age Related Macular Degeneration (ARMD)|
- BEST CORRECTED VISUAL ACUITY AFTER TREATMENTS [ Time Frame: 3, 6 12, 15, 18 AND 24 MONTHS AFTER ENTRY ] [ Designated as safety issue: No ]BEST CORRECTED VISUAL ACUITY AFTER TREATMENTS WITH THOSE ON SUPPLEMENTS VERSUS BEST CORRECTED VISUAL ACUITY OF THOSE WHO JUST RECEIVED TREATMENTS
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01527435
|Contact: Robert J Olk, MDfirstname.lastname@example.org|
|Contact: Jamie Conners||314-569-2020 ext email@example.com|
|United States, Missouri|
|The Retina Center||Recruiting|
|St. Louis, Missouri, United States, 63141|
|Contact: Jamie Conners 314-569-2020 ext 13 firstname.lastname@example.org|
|Contact: Kim A Thompson 314-569-2020 ext 12 email@example.com|
|Principal Investigator: Robert J Olk, MD|
|Sub-Investigator: Enrique Peralta, MD|
|Principal Investigator:||Robert J Olk, MD||The Retina Center|