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Prospective Study of Adjunctive Carotenoids Plus Anti-oxidants in Anti-VEGF Treated Diabetic Macular Edema

NCT03866005 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2020-07-02

No results posted yet for this study

Summary

This study will evaluate the effects of add-on carotenoid plus anti-oxidant nutritional supplementation to standard anti-vascular endothelial growth factor therapy for subjects with center-involved diabetic macular edema

Conditions

  • Center-involved Diabetic Macular Edema (CI-DME)

Interventions

DIETARY_SUPPLEMENT

Diabetes Visual Function Study (DiVFuSS) softgels

The adjunctive nutritional supplement will be the multi-component formula used in the Diabetes Visual Function Supplement Study (Western IRB number 1129944 Olympia, WA), containing the macular carotenoids lutein and zeaxanthin, as well as antioxidants (vitamins B1, B12, C, D, E, lipoic acid, coenzyme Q10, resveratrol), omega3 fatty acids (EPA/DHA) and botanical extracts (Pycnogenol™ \[patented extract of French maritime pine bark, Pinus pinaster\], grape seed and green tea extracts, curcumin).

OTHER

canola oil placebo softgels, 2 per day

Placebo containing canola oil, 2 softgels per day

Sponsors & Collaborators

  • Sound Retina

    collaborator OTHER

  • ZeaVision, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2021-11-01
Completion
2021-11-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03866005 on ClinicalTrials.gov