Evaluation of a New Eye-specific Multivitamin Formula in Participants at Risk of Age-related Macular Degeneration (AMD) (AMD)

Clinical Evaluation of a Micronized, Lipid-based Carotenoid Supplement in Eyes With Retinal Drusen

The aim of this study is to evaluate the clinical benefits in visual function from dietary supplementation of the Lumega-Z carotenoid liquid-supplement in participants with drusen and at risk of AMD. The effects of Lumega-Z supplementation will be compared to an active comparator, the AREDS2 multivitamin.

Study Overview

• Status: Completed
• Conditions: Macular Degeneration; Age-related Macular Degeneration; Retinal Drusen
• Intervention / Treatment: Dietary supplement: Lumega-Z; Dietary supplement: AREDS2

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78731
      • Eye Clinic of Austin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- patients with retinal drusen (as determined by clinical fundus photography examination) and dark adaptation recovery time of 6 to 10 minutes.

Exclusion Criteria:

• presence of congenital retinal pathologies that may impact data collection
• prior history of retinal-detachment or vitreo-retinal surgeries with any complications
• best-corrected visual acuity of 20/40 or worse

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Lumega-Z group; Participants assigned the study supplement Lumega-Z.	Dietary supplement: Lumega-Z; A specially-formulated carotenoid supplement formula that utilizes a micronized, lipid-based liquid form of delivery.; Other Names: LMZ
ACTIVE_COMPARATOR: AREDS2 group; Participants assigned the AREDS2 supplement	Dietary supplement: AREDS2; A commercially-available multivitamin soft gel formula.; Other Names: Preservision Age-Related Eye Disease Study 2 (AREDS2)
NO_INTERVENTION: Control; Participants are determined ocular normal after clinical examination and do not have retinal drusen.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Changes in Visual Acuity (VA)	Repeated measures were obtained using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart-based acuity exam. The ETDRS chart allows a geometric quantification the participant's visual acuity threshold for images under daylight-conditions of black & white contrast. Participant scores were reported as Logarithm of the Minimum Angle of Resolution (LogMAR) units; a more accurate, standardized value equated from the similar acuity charts. Per the clinical evaluation protocol, LogMAR scores of 0.00 - 0.20 are considered "good/normal visual acuity scores"; total range of 0.00 - 1.00. Scores are reported as averaged values, according to each respective group of participants and time-point from which the measurements were collected (i.e. baseline, 3-months, etc...). Exclusion criteria included LogMAR scores greater than, or equal to, 0.30 (equivalent to visual acuity of 20/40 or worse).	Baseline, 3-months, and 6-months
Mean Changes in Contrast Sensitivity (CS)	Contrast Sensitivity Function (CSF) was measured using the CSV-1000E device and measurements were analyzed as logCS units (logarithm of Contrast Sensitivity). The device measures both high- and low-contrast sensitivity (participant's ability to discern size and contrast) within a detection task, and reported as a response-curve. The curve compares the lowest contrast-level for a specific-sized target (across four spatial frequencies; per the manufacturer). Thus, the logCS unit of Contrast Sensitivity, is inversely related to the target's contrast level (displayed by the device). All measurements are reported as averaged values within each group, according to their respective time-frame within the study. Normal LogCS scores for adults aged 50-75 years old, in ascending order of spatial frequency (3, 6, 12, and 18), are (1.56 +/- 0.15), (1.80 +/- 0.165), (1.50 +/- 0.15), and (0.93 +/- 0.25). Values were utilized for scale, as recommended by the manufacturer/protocol.	Baseline, 3-months, and 6-months
Mean Changes in Dark Adaptation Recovery (DAR)	DAR measurements were collected using the AdaptDx adaptometer, to identify the participant's impaired dark adaptation threshold value (in response to low-light condition sensitivity). The device's software reported each patient's sensitivity-value over units of time (minutes), and were recorded as units of Rod Intercept Time. Similarly, measurements reported from each group were an averaged value amongst participant groups at each time-point of collection. According to the manufacturing protocol, a Rod Intercept Time of 6.5 minutes was determined to be the cut-off value for part of the inclusion criteria into treatment groups. Previous studies have demonstrated that scores equal to, or greater than, 6.5 minutes are indicative of early-AMD, and those less than 6.5 minutes are considered normal Rod Intercept values.	Baseline, 3-months, and 6-months
Mean Changes in Macular Pigment Optical Density (MPOD)	MPOD levels were measured by heterochromatic flicker photometry, using the MapCatSF device. MPOD (Macular Pigment Optical Density) measurements represent the level of light absorption by the macular pigment within the central retina, and provide measurements related to macular carotenoid densities. Measurements were reported as LogMAR units (total range of 0.00 to 1.00), as determined by the manufacture software program. Averaged values were reported within each group, at each time-point of collection. MPOD values between 0.22 - 0.44 logMAR units have been determined to be middle-range MPOD levels; average value in the USA approximately 0.35. Measurements between (0.0 - 0.21) were considered low-MPOD levels, and those between (0.45 - 1.0) were considered high-MPOD levels. All ranged-scores were obtained by recommendation from the manufacturer.	Baseline, 3-months, and 6-months

Collaborators and Investigators

• Sponsor: Guardion Health Sciences, Inc.
• Collaborators: Western University of Health Sciences; Eye Clinic of Austin
• Investigators: Principal Investigator: T Henderson, Eye Clinic of Austin

Publications and helpful links

General Publications

• Davey PG, Henderson T, Lem DW, Weis R, Amonoo-Monney S, Evans DW. Visual Function and Macular Carotenoid Changes in Eyes with Retinal Drusen-An Open Label Randomized Controlled Trial to Compare a Micronized Lipid-Based Carotenoid Liquid Supplementation and AREDS-2 Formula. Nutrients. 2020 Oct 26;12(11):3271. doi: 10.3390/nu12113271.

Helpful Links

• Link to the Lumega-Z medical food

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 19, 2018
• Primary Completion (ACTUAL): October 23, 2018
• Study Completion (ACTUAL): November 1, 2018

Study Registration Dates

• First Submitted: April 19, 2019
• First Submitted That Met QC Criteria: May 9, 2019
• First Posted (ACTUAL): May 10, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 10, 2019
• Last Update Submitted That Met QC Criteria: May 9, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Lumega-Z; Carotenoid supplement
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Retinal Drusen
• Other Study ID Numbers: Protocol Number 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD underlying the results in a publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No