Clinical trial NCT01527435: Addition of 20mg/Day Zeaxanthin to Triple Therapy Treatment Options for Age Related Macular Degeneration (ARMD)
Official title: Zeaxanthin as an Adjuvant to Combination Therapy for Treatment of Choroidal Neovascularization (CNV) in Exudative Age Related Macular Degeneration (ARMD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exudative Age-Related Macular Degeneration
Keywords: Best corrected visual acuity
Slit lamp examination
Ophthalmoscopy with contact lens/indirect ophthalmoscope
OCT assessment
Fundus photos, fluorescein angiogram, ICG angiogram
Lead sponsor: The Retina Center of St. Louis County, PC
Sponsor class: OTHER
Collaborators: name: ZeaVision, Inc.
First posted: 2012-02-07
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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 AREDS(PreserVision) 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 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.

Eligibility 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.

Primary outcomes:
measure: BEST CORRECTED VISUAL ACUITY AFTER TREATMENTS
timeFrame: 3, 6 12, 15, 18 AND 24 MONTHS AFTER ENTRY
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: The Retina Center
state: Missouri
Study officials:
affiliation: The Retina Center
name: Robert J Olk, MD
role: PRINCIPAL_INVESTIGATOR
References: