Diabetic Retinopathy Functional Evaluation Study: Monitoring Carotenoid Vitamins Treatment Using ERG

NCT04117022 | Unknown DMC

• 1 other identifier: 19-094
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 2

Brief Summary

To evaluate the differences in retinal function as measured by ERG in diabetics with and without retinopathy 2) the ability of the Chromatic Electroretinogram (chERG) to detect changes in global retinal function following treatment with Carotenoid Vitamins supplement in patients with diabetic retinopathy (DR). 3) the ability of the Full Field flicker (ffERG) to detect changes in global retinal function following treatment with Carotenoid Vitamins supplement in patients with diabetic retinopathy (DR). 4\) Changes in retinal function as observed by OCT-Angiography, following treatment with Carotenoid Vitamins supplement in patients with diabetic retinopathy (DR).

Conditions

Diabetes; Diabetic Retinopathy

Outcome Measures

Primary Outcomes (2)

• Chromatic ERG (ChERG) Outcome Measurements: B wave and PhNR latency (milliseconds) Full field ERG outcome measurements and Chromatic ERG Outcome Measurements

  The Chromatic Electroretinogram (chERG) and the full field ERG will be recorded using a commercially available system Diopsys® NOVA (Diopsys, Inc. Pine Brook, New Jersey). The Red-Blue stimulus will be presented using a mini-Ganzfeld handheld device. The entire process consists of two tests per eye, with twenty-five seconds allocated for each test; thus, the total duration of the test is one hundred seconds. The chERG will be consecutively recorded from both eyes by means of proprietary adhesive skin electrodes on the lower eyelid and forehead.

  Change from Baseline to 6 months

• Full-field flicker ERG (ffERG) Measurements: magnitude (microvolts) and the phase (milliseconds) and the area ratio for magnitude and the area ratio for Phase

  The Flicker ERG will be recorded using a commercially available system, Diopsys® NOVA (Diopsys, Inc., Pine brook, NJ), version 2.19.19778.7332). The Flicker ERG will be consecutively recorded from both eyes by means of adhesive skin electrodes on the lower eyelid and skin. The stimulus will consist of white flashes flickering at 32 Hz over a white background as well as a sequence of 6 steps of increasing luminance.

  Change from Baseline to 6 months

Secondary Outcomes (2)

• Macular pigment optical density (MPOD in relative density units)

  Change from Baseline to 6 months

• Optical coherence tomography angiography (OCTA): radial macular and optic nerve capillary density (number/square millimeter)

  Change from Baseline to 6 months

Study Arms (1)

supplemented arm

EXPERIMENTAL

Each subject will receive DVS formula, 2 softgels per day for 6 months.

Dietary Supplement: DVS supplementation

Interventions

DVS supplementation DIETARY_SUPPLEMENT

Oral supplement. Each subject will be given the carotenoid supplement of DVS formula. The DVS formula consists of vitamins C, D3 and E (d-α tocopherol), zinc oxide, eicosapentaenoic acid, docosahexaenoic acid, α-lipoic acid (racemic mixture), coenzyme Q10, mixed tocotrienols/tocopherols, zeaxanthin, lutein, benfotiamine, N-acetyl cysteine, grape seed extract, resveratrol, turmeric root extract, green tea leaf, and Pycnogenol (patented French Maritime Pine Bark extract, sp Pinus pinaster, Horphag Research, Geneva, Switzerland). Supplements bottles will be labelled with a unique identification number for each subject and supplied by ZeaVision, LLC, Chesterfield, Missouri, USA. To assure that the participants do not have any issues with the vitamin supplement and to ensure adequate adherence to schedule of vitamin intake the participants will get regular phone calls from the study investigators (once every two weeks).

supplemented arm

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21-80 years
• History of Diabetes for at least \> 5years
• No retinopathy, Mild or Moderate Non-Proliferative diabetic retinopathy
• Diabetes without retinopathy (Appendix A)
• Mild to moderate NPDR as defined by the American Academy of Ophthalmology7 (Appendix A)

You may not qualify if:

• History of any systemic or ophthalmic condition (other than diabetic retinopathy) capable of affecting vision
• Presence of Diabetic Macular Edema
• History of intraocular surgery, including macular or panretinal photocoagulation laser (except uncomplicated cataract or keratorefractive surgery more than 6 months prior to enrollment)
• History of treatment affecting vision, influencing reaction time and/or drugs indicating severe general diseases (eg. Hydroxychloroquine, tamoxifen, dexamethasone, triamcinolone, fluocinolone, etc.)
• Spherical refraction outside ±5.0 D or cylinder correction outside ±3.0 D
• Inability to obtain reliable Chromatic ERG test
• Pregnant and nursing women
• Allergy to the supplement or any of its ingredients
• Any subject that all ERG study tests or the OCT angiography cannot be obtained reliably.

Sponsors & Collaborators

• ZeaVision, LLC: lead
• Northeastern State University: collaborator
• Western University of Health Sciences: collaborator
• Diopsys, Inc.: collaborator

Study Sites (2)

Western Universit5y of Health Sciences, College of Optometry

Pomona, California, 91766, United States

RECRUITING

Oklahoma College of Optometry, Northeastern State University

Tahlequah, Oklahoma, 74464, 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

Study Officials

• Nathan Lighthizer, OD

  Northeastern State University, School of Optometry

  STUDY CHAIR

• Pinakin Davey, OD, PhD

  Western University of Health Sciences, College of Optometry

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pinakin Davey, OD, PhD

CONTACT

909-469-8473 |; pdavey@westernu.edu

Nathan Lighthizer, OD

CONTACT

918-444-4007; lighthiz@nsuok.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Each site will evaluate 15 diabetics after comprehensive ophthalmic examination and with a confirmed diagnosis at least greater than 5 years without retinopathy or mild-moderate retinopathy..Flicker and chromatic ERG, macular pigment optical density, and ultrawide-field undus photography will be conducted at baseline and after 6-months supplementation with a novel multi-component nutritional supplement (DVS)

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 7, 2019
• Study Start: September 1, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2022
• Last Updated: April 23, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)