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

NCT01527435 | Completed

• 1 other identifier: 11-06-0044
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• BEST CORRECTED VISUAL ACUITY AFTER TREATMENTS

  BEST CORRECTED VISUAL ACUITY AFTER TREATMENTS WITH THOSE ON SUPPLEMENTS VERSUS BEST CORRECTED VISUAL ACUITY OF THOSE WHO JUST RECEIVED TREATMENTS

  3, 6 12, 15, 18 AND 24 MONTHS AFTER ENTRY

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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.

Sponsors & Collaborators

• The Retina Center of St. Louis County, PC: lead
• ZeaVision, Inc.: collaborator

Study Sites (1)

The Retina Center

St Louis, Missouri, 63141, United States

Location

Related Publications (1)

• Brown GC, Brown MM, Gierhart D, Olk RJ. Prevention Surpasses Treatment: 5-year Follow-Up, Cost-Utility, and Cost-Benefit of Zeaxanthin Therapy for Neovascular Age-Related Macular Degeneration. Ophthalmol Ther. 2023 Oct;12(5):2583-2608. doi: 10.1007/s40123-023-00742-9. Epub 2023 Jul 10.

  PMID: 37430077 DERIVED

Study Officials

• Robert J Olk, MD

  The Retina Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2012
• First Posted: February 7, 2012
• Study Start: December 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 6, 2016

Record last verified: 2016-04

Locations

US (1)