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

Study Overview
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Brief Summary
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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.

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

Conditions
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Retinal Drusen, Age-related Macular Degeneration, Macular Degeneration

Intervention / Treatment
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* Dietary Supplement: Lumega-Z
* Dietary Supplement: AREDS2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel treatment group participants will be randomly assigned either the experimental intervention, Lumega-Z, or the AREDS2 supplement. An observational, control group will be included for further comparison.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lumega-Z group<br>Participants assigned the study supplement Lumega-Z. | Dietary Supplement: Lumega-Z<br>* A specially-formulated carotenoid supplement formula that utilizes a micronized, lipid-based liquid form of delivery.<br>* Other names: LMZ;|
| Active Comparator: AREDS2 group<br>Participants assigned the AREDS2 supplement | Dietary Supplement: AREDS2<br>* A commercially-available multivitamin soft gel formula.<br>* Other names: Preservision Age-Related Eye Disease Study 2 (AREDS2);|
| No Intervention: Control<br>Participants are determined ocular normal after clinical examination and do not have retinal drusen. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumega-Z, Carotenoid supplement