Clinical trial NCT04117022: Diabetic Retinopathy Functional Evaluation Study: Monitoring Carotenoid Vitamins Treatment Using ERG
Official title: Diabetic Retinopathy Functional Evaluation Study: Monitoring Carotenoid Vitamins Treatment Using ERG
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes
Diabetic Retinopathy
Lead sponsor: ZeaVision, LLC
Sponsor class: INDUSTRY
Collaborators: name: Northeastern State University
name: Western University of Health Sciences
name: Diopsys, Inc.
First posted: 2019-10-07
Enrollment: 45
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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

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.

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.

Primary outcomes:
measure: Chromatic ERG (ChERG) Outcome Measurements: B wave and PhNR latency (milliseconds) Full field ERG outcome measurements and Chromatic ERG Outcome Measurements
timeFrame: Change from Baseline to 6 months
measure: Full-field flicker ERG (ffERG) Measurements: magnitude (microvolts) and the phase (milliseconds) and the area ratio for magnitude and the area ratio for Phase
timeFrame: Change from Baseline to 6 months
Secondary outcomes:
measure: Macular pigment optical density (MPOD in relative density units)
timeFrame: Change from Baseline to 6 months
measure: Optical coherence tomography angiography (OCTA): radial macular and optic nerve capillary density (number/square millimeter)
timeFrame: Change from Baseline to 6 months
Other outcomes:
Locations:
city: Pomona
country: United States
facility: Western Universit5y of Health Sciences, College of Optometry
state: California
city: Tahlequah
country: United States
facility: Oklahoma College of Optometry, Northeastern State University
state: Oklahoma
Study officials:
affiliation: Northeastern State University, School of Optometry
name: Nathan Lighthizer, OD
role: STUDY_CHAIR
affiliation: Western University of Health Sciences, College of Optometry
name: Pinakin Davey, OD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.