Status:
COMPLETED
Addition of 20mg/Day Zeaxanthin to Triple Therapy Treatment Options for Age Related Macular Degeneration (ARMD)
Lead Sponsor:
The Retina Center of St. Louis County, PC
Collaborating Sponsors:
ZeaVision, Inc.
Conditions:
Exudative Age-Related Macular Degeneration
Eligibility:
All Genders
50+ years
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 de...
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-inf...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01527435
Start Date
December 1 2011
End Date
December 1 2015
Last Update
April 6 2016
Active Locations (1)
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1
The Retina Center
St Louis, Missouri, United States, 63141