View Clinical Trial (Medical Research Study)
Zeaxanthin as an Adjuvant to Combination Therapy for Treatment of Choroidal Neovascularization (CNV) in Exudative Age Related Macular Degeneration (ARMD)
| City: |
|
St. Louis |
| State: |
|
Missouri |
| Zip Code: |
|
63141 |
| Conditions: |
|
Exudative Age-Related Macular Degeneration |
| Purpose: |
|
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.
|
| Study Summary: |
|
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.
|
| Criteria: |
|
Inclusion Criteria:
1. Male or female at least 50 years of age.
2. Subjects must have age related macular degeneration with a choroidal neovascular
membrane either classic or occult in at least one eye.
3. Preoperative best corrected visual acuity (BCVA) equal to or greater to 19 letters on
the ETDRS diabetic retinopathy study chart (20/400 Snellen).
4. Media clarity, pupillary dilation and subject cooperation sufficient for accurate OCT
and angiographic assessment.
5. Written and informed consent has been obtained.
6. Written authorization for the use and release of the health and research study
information in the United States of America USA.
7. Ability to understand the informed consent and willingness to follow study
instruction and likely to complete all required visits and procedures.
Exclusion Criteria:
1. Evidence of diabetic retinopathy or other retinal disease other than age related
macular degeneration.
2. Any severe active ocular disease or condition that in the opinion of the investigator
is severe enough to prevent a 3 line improvement in visual acuity or to compromise
the study results.
3. Any presumed ocular infections, i.e. bacterial, viral, parasitic, or fungal in either
eye at the baseline visit.
4. Contraindication to pupillary dilation in either eye.
5. Uncontrolled systemic disease.
6. Any condition (including inability to read visual acuity charts and language
barriers) which precludes subjects ability to comply with the study requirements
including the completion of the study.
7. Subject has a condition or is in a situation which the investigator's opinion may
put the subject at significant risk, may confound the study results or may interfere
significantly with the subjects participation in the study.
|
| NCT ID: |
|
NCT01527435 |
| Primary Contact: |
|
Principal Investigator
Robert J Olk, MD
The Retina Center
Robert J Olk, MD
Phone: 314-569-2020
Email: rjolk@retina-stl.com
|
| Backup Contact: |
|
Email: jamiehickerson@retina-stl.com
Jamie Conners
Phone: 314-569-2020 ext. 13
|
| Location Contact: |
|
St. Louis, Missouri 63141
United States
Jamie Conners
Phone: 314-569-2020
Email: jamiehickerson@retina-stl.com
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
June 19, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|