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

NCT ID: NCT04117022

Last Updated: 2021-04-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2022-12-01

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.

Conditions

Diabetes; Diabetic Retinopathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

supplemented arm

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

Group Type: EXPERIMENTAL

DVS supplementation

Intervention Type: 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).

Interventions

DVS supplementation

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).

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northeastern State University

OTHER

Sponsor Role: collaborator

Western University of Health Sciences

OTHER

Sponsor Role: collaborator

Diopsys, Inc.

INDUSTRY

Sponsor Role: collaborator

ZeaVision, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nathan Lighthizer, OD

Role: STUDY_CHAIR

Northeastern State University, School of Optometry

Pinakin Davey, OD, PhD

Role: PRINCIPAL_INVESTIGATOR

Western University of Health Sciences, College of Optometry

Locations

Western Universit5y of Health Sciences, College of Optometry

Pomona, California, United States

Site Status: RECRUITING

Oklahoma College of Optometry, Northeastern State University

Tahlequah, Oklahoma, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Pinakin Davey, OD, PhD

Role: CONTACT

pdavey@westernu.edu

909-469-8473 |

Nathan Lighthizer, OD

Role: CONTACT

lighthiz@nsuok.edu

918-444-4007

Facility Contacts

Pinakin G. Davey, OD, PhD

Role: primary

contact@pinakin-gunvant.com

901-831-1562

Ida Chung, OD, MSHE

Role: backup

ichung@westernu.edu

909-469-8687

Nathan R. Lighthizer, OD

Role: primary

lighthiz@nsuok.edu

918-444-4007

Richard E. Castillo, OD

Role: backup

castillo@nsuok.edu

(918) 444-4038

References

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.

Reference Type: RESULT

PMID: 26089210 (View on PubMed)

Other Identifiers

19-094

Identifier Type: -

Identifier Source: org_study_id