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

NCT03866005 | Unknown DMC

• 1 other identifier: PROACTIVE-DME
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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)

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Best-corrected visual acuity

  Best-corrected visual acuity at entry and conclusion of study

  two years

• SD-OCT macular subfield thicknesses

  Change in macular subfield thicknesses from baseline to study conclusion

  two years

• Required number of anti-VEGF injections

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

  two years

Secondary Outcomes (1)

• Need for adjunctive laser photocoagulation and/or use of intravitreal steroids

  two years

Study Arms (3)

Placebo Arm - Standard Treatment

PLACEBO COMPARATOR

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

Experimental Arm - 2 DiVFuSS formula softgel capsules

EXPERIMENTAL

50 subjects receiving two DiVFuSS softgels per day

Dietary Supplement: Diabetes Visual Function Study (DiVFuSS) softgels

Experimental Arm - 4 DiVFuSS formula softgel capsules

EXPERIMENTAL

50 subjects receiving 4 DiVFuss softgels per day

Dietary Supplement: Diabetes Visual Function Study (DiVFuSS) softgels

Interventions

Diabetes Visual Function Study (DiVFuSS) softgels DIETARY_SUPPLEMENT

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 Arm - 2 DiVFuSS formula softgel capsules; Experimental Arm - 4 DiVFuSS formula softgel capsules

canola oil placebo softgels, 2 per day OTHER

Placebo containing canola oil, 2 softgels per day

Placebo Arm - Standard Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• ZeaVision, LLC: lead
• Sound Retina: collaborator

Study Sites (2)

Sound Retina

Olympia, Washington, 98506, United States

RECRUITING

Sound Retina

Tacoma, Washington, 98405, United States

RECRUITING

Related Publications (1)

• Chous AP, Richer SP, Gerson JD, Kowluru RA. The Diabetes Visual Function Supplement Study (DiVFuSS). Br J Ophthalmol. 2016 Feb;100(2):227-34. doi: 10.1136/bjophthalmol-2014-306534. Epub 2015 Jun 18.

  PMID: 26089210 RESULT

MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications

Central Study Contacts

Jay M Haynie, OD

CONTACT

(253) 572-1444; drjay@soundretina.com

A. Paul Chous, OD

CONTACT

4257366251; dr_chous@diabeticeyes.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: March 7, 2019
• Study Start: November 1, 2019
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: July 2, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)