Recruiting

Carotenoids & Anti-oxidants

Sponsor:

ZeaVision, LLC

Code:

NCT03866005

Conditions

Center-involved Diabetic Macular Edema (CI-DME)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Diabetes Visual Function Study (DiVFuSS) softgels

canola oil placebo softgels, 2 per day

Study Details

Brief 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)

Study ID

NCT03866005

Start date

Nov 1, 2019

Status verified date

Jun, 2020

Completion date

Nov 1, 2021

Anticipated

Primary completion date

Nov 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosed diabetes mellitus and treatment-naïve CI-DME requiring anti-VEGF therapy per retinal specialist's customary treatment regimen will be recruited to participate in the study. CI-DME will be defined as a central subfield thickness (CST) > 300 microns on spectral domain optical coherence tomography (SD-OCT) or CST > 250 microns with definite intra-retinal cystic fluid accumulation. Additional inclusion criteria are age > 18 years, and ability to give informed consent.

Exclusion Criteria:

  • Age < 18 years, inability to give informed consent, evidence of proliferative diabetic retinopathy, evidence of other serious ocular disease (age-related macular degeneration, glaucoma, significant media opacity), history of previous intraocular surgery, including macular or panretinal photocoagulation (except uncomplicated cataract or keratorefractive surgery more than 6 months prior to enrollment), pregnant and nursing women, known sensitivity to any of the supplement ingredients.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo Arm - Standard Treatment

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

experimental: Experimental Arm - 2 DiVFuSS formula softgel capsules

50 subjects receiving two DiVFuSS softgels per day

experimental: Experimental Arm - 4 DiVFuSS formula softgel capsules

50 subjects receiving 4 DiVFuss softgels per day

Interventions

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).

canola oil placebo softgels, 2 per day

Placebo containing canola oil, 2 softgels per day

Primary outcome measure

  • Best-corrected visual acuity [ Time Frame: two years ]
  • SD-OCT macular subfield thicknesses [ Time Frame: two years ]
  • Required number of anti-VEGF injections [ Time Frame: two years ]

Central Contacts and Locations

Central contacts

Jay M Haynie, OD

(253) 572-1444drjay@soundretina.com

A. Paul Chous, OD

4257366251dr_chous@diabeticeyes.com

Locations

Sound Retina

Recruiting

Olympia, Washington, United States, 98506

Contacts

Jay M Haynie, OD

253-572-1444drjay@soundretina.com

Sound Retina

Recruiting

Tacoma, Washington, United States, 98405

Contacts

Jay M Haynie, OD

253-572-1444drjay@soundretina.com

A. Paul Chous, OD

425-736-6251dr_chous@diabeticeyes.com

More Information

Sponsor

ZeaVision, LLC

Last update posted

Jul 2, 2020

Last verified

Jun, 2020

Keywords

  • diabetes, retina, diabetic retinopathy, diabetic macular edema, anti-VEGF therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by ZeaVision, LLC on 2020-07-02.