50 subjects with center-involved diabetic macular edema (CI-DME) and scheduled for treatment with intravitreal injection of anti-VEGF agents will receive softgel placebo containing canola oil, 2 capsules per day during the study duration

50 subjects receiving two DiVFuSS softgels per day

50 subjects receiving 4 DiVFuss softgels per day

Center-involved Diabetic Macular Edema (CI-DME)

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).

Diabetes Visual Function Study (DiVFuSS) softgels

Placebo containing canola oil, 2 softgels per day

canola oil placebo softgels, 2 per day

Sound Retina

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

Best-corrected visual acuity at entry and conclusion of study

Change in macular subfield thicknesses from baseline to study conclusion

The number of intravitreal anti-VEGDF injections required for treatment of center-involved diabetic macular edema

The number of subjects in each arm requiring adjunctive laser photocoagulation or intravitreal steroids for treatment of CI-DME

ZeaVision, LLC

This will be an investigator initiated, single-clinic/two location, double-blinded prospective study of 150 adult subjects with newly diagnosed CI-DME receiving anti-VEGF injections, with add-on laser and/or steroid as required on follow-up examination (Standard Treatment) versus standard treatment plus adjunctive DiVFuSS supplementation in one of two doses (2 softgels per day - Supplement Treatment Group 1; and 4 softgels per day - Supplement Treatment Group 2). Subjects will be identified and enrolled with informed consent from two retinal specialty practice sites in Washington State (Sound Retina; Tacoma, WA and Olympia, WA). Subjects will be randomized to Standard Treatment; Supplement Treatment Group 1, or Supplement Treatment Group 2.

After enrollment by the study Primary Investigator, a single retinal specialist from each site, masked to subjects' supplement status, will deliver all treatments per his/her usual protocol for treatment of CI-DME based on individual examination findings. Supplements and identically-appearing placebo will be provided by ZeaVision, LLC of Chesterfield, MO.

zeaxanthin/péine

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

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