An Investigation of Vitamin A Palmitate Supplementation in Patients With Age-Related Macular Degeneration (and Without Reticular Pseudodrusen) and Delayed Dark Adaptation

  • STATUS
    Recruiting
  • End date
    Sep 1, 2023
  • participants needed
    20
  • sponsor
    National Eye Institute (NEI)
Updated on 19 August 2022
vasectomy
tubal ligation
hysterectomy
urine tests
be 50
blindness
eye exam
reticular pseudodrusen
ophthalmic solution
eye drops
vitamin
eye disease
age-related macular degeneration
macular degeneration
retinal diseases

Summary

Background

Age-related macular degeneration (AMD) is an eye disease. It is the leading cause of vision loss in people over 55 in the U.S. Changes in the eye can make it difficult for the eye to adjust to low light. This is known as dark adaptation. Identifying and watching the early to middle stages of AMD and changes in dark adaptation might help researchers develop new treatments to stop the disease before it becomes severe. Taking vitamin A might help improve vision in people with AMD.

Objectives

To see if taking 16,000 IU of vitamin A per day improves vision in people with AMD. Also to improve understanding of AMD and associated dark adaptation.

Eligibility

Adults ages 50 and older with AMD and normal liver function

Design

Participants will be screened with:

Medical and eye disease history

Eye exam: The pupil will be dilated with eye drops. Pictures will be taken of the retina and the inside of the eye.

Including the screening visit, participants will have at least 5 visits. They will be about once a month over 6 months. Visits include:

Questions about eye problems in certain light

Eye exam

Blood and urine tests

Dark adaptation protocol: Participants will sit at a machine in a dark room. They will look into the machine and push a button when they see a light. This lasts 20-30 minutes.

Participants will take a vitamin A supplement by mouth once a day for 2 months. They will record when they take the pills in a diary.

Description

Objective

The objective of this study is to investigate the potential efficacy and safety of vitamin A palmitate dosing in improving dark adaptation in participants with age-related macular degeneration (AMD) and abnormal dark adaptation.

Study Population:

The first cohort consists of five participants with AMD who meet the eligibility criteria. The second cohort will consist of five participants with AMD who meet the eligibility criteria. Up to five additional participants may be accrued in the second cohort to account for participants who withdraw from the study prior to receiving one month of study supplementation for a reason unrelated to an adverse reaction. Up to 18 participants may be enrolled in this study.

Design

This is a prospective, uncontrolled, single center, pilot study to investigate the potential efficacy and safety of vitamin A palmitate dosing in improving dark adaptation in participants with AMD and abnormal dark adaptation. Participants in the first cohort were instructed to take 16,000 IU of vitamin A palmitate daily for two months. Enrollment for Cohort 1 ended on May 24, 2019. Participants in the second cohort will be instructed to take 48,000 IU of vitamin A palmitate daily for one month. Participants in both cohorts will continue in the study for one month after ending Vitamin A supplementation. Participants in Cohort 1 may enroll into Cohort 2 as long as their last intake of vitamin A palmitate was greater than two months prior to their enrollment into Cohort 2.

Outcome Measures:

For each cohort, the primary outcome is the measurement of dark adaptation parameters (thresholds and kinetics) by the following: dark adaptation times as measured by the AdaptDx comparing before and after vitamin A palmitate supplementation and dark adaptation parameters as measured by the Medmont comparing before and after vitamin A palmitate supplementation. The primary outcome will be assessed at Month 2 in the first cohort and Month 1 in the second cohort. For both cohorts, the secondary outcomes include changes in low luminance visual acuity (LLVA) and changes in patient reported outcomes as measured by the low luminance questionnaire (LLQ). The secondary outcomes also include measurement of dark adaptation parameters (thresholds and kinetics) comparing baseline and one month after completing supplementation (Month 3 in Cohort 1 and Month 2 in Cohort 2).

Details
Condition AMD
Treatment Vitamin A palmitate
Clinical Study IdentifierNCT03478865
SponsorNational Eye Institute (NEI)
Last Modified on19 August 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

The eye must have a best-corrected ETDRS visual acuity score better than or equal to
Participant must have at least one large druse
80 (i.e., equal to or better than 54 letters)
Abnormal dark adaptation, which is defined as having an Adapt Dx test with a RIT of 16
minutes or more at the screening visit. This is at least one standard deviation
greater than the average normal RIT and includes room to account for variability in
testing. If at any point during current testing or under a previous NEI protocol, a
participant has exceeded the 40 minute test ceiling, they will have satisfied the
inclusion criteria

Exclusion Criteria

Presence of definite reticular pseudodrusen
Presence of advanced macular degeneration with central geographic atrophy or choroidal
neovascularization
An ocular condition is present (other than retinal vein occlusion) that, in the
opinion of the investigator, might alter visual acuity during the course of the study
(e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular
glaucoma, Irvine-Gass Syndrome, etc.)
Substantial cataract that, in the opinion of the investigator, is likely to be
decreasing visual acuity by three lines or more (i.e., cataract would be reducing
acuity to 20/40 or worse if eye was otherwise normal)
History of major ocular surgery (e.g. cataract extraction, scleral buckle, any
intraocular surgery, etc.) within three months prior to study entry
History of YAG (Yttrium-Aluminum Garnet) capsulotomy performed within two months prior
to study entry
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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