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

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ClinicalTrials.gov Identifier: NCT03866005
Recruitment Status : Not yet recruiting
First Posted : March 7, 2019
Last Update Posted : March 14, 2019
Sponsor:
Collaborator:
Sound Retina
Information provided by (Responsible Party):
ZeaVision, LLC

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

Condition or disease Intervention/treatment Phase
Center-involved Diabetic Macular Edema (CI-DME) Dietary Supplement: Diabetes Visual Function Study (DiVFuSS) softgels Other: canola oil placebo softgels, 2 per day Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Prospective Study of Adjunctive Carotenoids Plus Anti-oxidants in Anti-VEGF Treated Diabetic Macular Edema
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antioxidants Edema
Drug Information available for: Bevacizumab

Arm Intervention/treatment
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
Other: canola oil placebo softgels, 2 per day
Placebo containing canola oil, 2 softgels per day

Experimental: Experimental Arm - 2 DiVFuSS formula softgel capsules
50 subjects receiving two DiVFuSS softgels per day
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).

Experimental: Experimental Arm - 4 DiVFuSS formula softgel capsules
50 subjects receiving 4 DiVFuss softgels per day
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).




Primary Outcome Measures :
  1. Best-corrected visual acuity [ Time Frame: two years ]
    Best-corrected visual acuity at entry and conclusion of study

  2. SD-OCT macular subfield thicknesses [ Time Frame: two years ]
    Change in macular subfield thicknesses from baseline to study conclusion

  3. Required number of anti-VEGF injections [ Time Frame: two years ]
    The number of intravitreal anti-VEGDF injections required for treatment of center-involved diabetic macular edema


Secondary Outcome Measures :
  1. Need for adjunctive laser photocoagulation and/or use of intravitreal steroids [ Time Frame: two years ]
    The number of subjects in each arm requiring adjunctive laser photocoagulation or intravitreal steroids for treatment of CI-DME



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03866005


Contacts
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Contact: Jay M Haynie, OD (253) 572-1444 drjay@soundretina.com
Contact: A. Paul Chous, OD 4257366251 dr_chous@diabeticeyes.com

Locations
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United States, Washington
Sound Retina
Olympia, Washington, United States, 98506
Sound Retina Not yet recruiting
Tacoma, Washington, United States, 98405
Contact: Jay M Haynie, OD    253-572-1444    drjay@soundretina.com   
Contact: A. Paul Chous, OD    425-736-6251    dr_chous@diabeticeyes.com   
Sponsors and Collaborators
ZeaVision, LLC
Sound Retina

Publications of Results:
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Responsible Party: ZeaVision, LLC
ClinicalTrials.gov Identifier: NCT03866005     History of Changes
Other Study ID Numbers: PROACTIVE-DME
First Posted: March 7, 2019    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by ZeaVision, LLC:
diabetes, retina, diabetic retinopathy, diabetic macular edema, anti-VEGF therapy

Additional relevant MeSH terms:
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Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Carotenoids
Antioxidants
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents