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

ZeaVision

Status: Unknown

Conditions: Diabetes; Diabetic Retinopathy

Treatments: Dietary Supplement: DVS supplementation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04117022

19-094

Details and patient eligibility

About

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).

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

supplemented arm

Experimental group

Description:

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

Treatment:

Dietary Supplement: DVS supplementation