Addition of 20mg/Day Zeaxanthin to Triple Therapy Treatment Options for Age Related Macular Degeneration (ARMD)

Completed

Conditions studied: Exudative Age-Related Macular Degeneration

In brief

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.

Key facts

Study ID

NCT01527435

Run by

The Retina Center of St. Louis County, PC

People needed

200

Starts

2011-12-01

Expected to finish

2015-12-01

Last updated by the study team

2016-04-06

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female at least 50 years of age.
• Subjects must have age related macular degeneration with a choroidal neovascular membrane either classic or occult in at least one eye.
• Preoperative best corrected visual acuity (BCVA) equal to or greater to 19 letters on the ETDRS diabetic retinopathy study chart (20/400 Snellen).
• Media clarity, pupillary dilation and subject cooperation sufficient for accurate OCT and angiographic assessment.
• Written and informed consent has been obtained.
• Written authorization for the use and release of the health and research study information in the United States of America USA.
• Ability to understand the informed consent and willingness to follow study instruction and likely to complete all required visits and procedures.

You may not qualify if…

• Evidence of diabetic retinopathy or other retinal disease other than age related macular degeneration.
• 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.
• Any presumed ocular infections, i.e. bacterial, viral, parasitic, or fungal in either eye at the baseline visit.
• Contraindication to pupillary dilation in either eye.
• Uncontrolled systemic disease.
• 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.
• 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.

Where it is running

• The Retina Center — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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