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

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

Sponsors

Lead Sponsor: ZeaVision, LLC

Collaborator: Northeastern State University
Western University of Health Sciences
Diopsys, Inc.

Source ZeaVision, LLC
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).

Detailed Description

This prospective, study has cross-sectional analysis of ERG functions in a group of diabetics with and without retinopathy. Both Chromatic ERG and Full field ERG (NOVA, Diopsys, Inc. Pine Brook, NJ) will be utilized in the study. Subsequently individuals with an outside normal limit outcome on at least one ERG test will be invited to be part of the longitudinal study. Individuals with abnormal ERG results will be asked to take the carotenoid vitamin supplement (ZeaVision DVS supplement) and the baseline data will be compared to the values at one, three- and six-month follow-up. The primary endpoint of a patient's follow-up will be at 6 months. The study will be performed at three sites. Western University of Health Sciences, Harpers Pointe Eye Associates (Externship site College of Optometry, Western University of Health Sciences) and Oklahoma College of Optometry, Northeastern State University, Tahlequah, Oklahoma. The clinical study plan will be reviewed and approved by Eye Care Center of the Western University of Health Sciences Institutional Review Board (IRB). Harpers Pointe Eye Associates will be covered under an externship site of Western University of Health Sciences. NSUOCO will apply for a separate IRB review at their own site.

Overall Status Recruiting
Start Date September 1, 2019
Completion Date December 1, 2020
Primary Completion Date December 1, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Chromatic ERG (ChERG) Outcome Measurements: B wave and PhNR latency (milliseconds) Full field ERG outcome measurements and Chromatic ERG Outcome Measurements 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 Change from Baseline to 6 months
Secondary Outcome
Measure Time Frame
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
Enrollment 45
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: DVS supplementation

Description: 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).

Arm Group Label: supplemented arm

Eligibility

Criteria:

Inclusion Criteria: - Age 21-80 years 1. History of Diabetes for at least > 5years 2. 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) Exclusion Criteria: - • 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.

Gender: All

Minimum Age: 21 Years

Maximum Age: 80 Years

Healthy Volunteers: No

Overall Official
Overall Contact

Last Name: Pinakin Davey, OD, PhD

Phone: 909-469-8473 |

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup:
Western Universit5y of Health Sciences, College of Optometry | Pomona, California, 91766, United States Recruiting Pinakin G. Davey, OD, PhD 901-831-1562 [email protected]
Oklahoma College of Optometry, Northeastern State University | Tahlequah, Oklahoma, 74464, United States Recruiting Nathan R. Lighthizer, OD 918-444-4007 [email protected] Pinakin Davey, OD, PhD Principal Investigator Nathan R. Lighhizer, OD Principal Investigator
Location Countries

United States

Verification Date

June 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: supplemented arm

Type: Experimental

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

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Intervention Model Description: 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)

Primary Purpose: Diagnostic

Masking: None (Open Label)

Source: ClinicalTrials.gov