An Investigation of Vitamin A Palmitate Supplementation in Patients With Reticular Pseudodrusen (RPD) and Delayed Dark Adaptation
Sponsor study identifier
Secondary identifiers
interventional
9
1 country
1
Study Start
May 14, 2018
Actual (reported)Primary Completion
June 17, 2022
Actual (reported)Study Completion
June 17, 2022
Actual (reported)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 they eye to adjust to low light. This is known as dark adaptation. This is particularly significant in people with reticular pseudodrusen (RPD). Identifying and watching the early to middle stages of AMD and changes in dark adaptation might help researchers learn to stop the disease before it becomes severe. Taking vitamin A might help improve vision in people with RPD. Objectives: To see if taking 16,000 IU of vitamin A per day improves vision in people with RPD. Also to improve understanding of RPD and associated dark adaptation. Eligibility: Adults ages 50 and older with RPD 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 and last 4-6 hours. 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 20-40 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 17, 2022
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 21, 2018
Actual (reported)March 27, 2018
Actual (reported)May 14, 2018
Actual (reported)June 17, 2022
Actual (reported)June 17, 2022
Actual (reported)July 3, 2024
Actual (reported)Change in Dark Adaptation Rod Intercept Time (RIT) From Baseline in the Study Eye at the Treatment Completion Visit (Month 2 for Cohort 1 and Month 1 for Cohort 2)
The mean change in rod intercept time (RIT) in the study eye at the treatment completion visit from baseline was descriptively summarized and assessed using a Student's paired t-test at a two-sided Type I error rate of 5%.
Baseline to Month 2 for Cohort 1 and Baseline to Month 1 for Cohort 2
Change in Dark Adaptation Rod Intercept Time (RIT) From Baseline in the Study Eye at the Post-Treatment Follow-Up Visit (Month 3 for Cohort 1 and Month 2 for Cohort 2)
Baseline to Month 3 for Cohort 1 and Baseline to Month 2 for Cohort 2
Change in Low Luminance Visual Acuity (LLVA) From Baseline in the Study Eye at the Treatment Completion and Post-Treatment Follow-Up Visits
Treatment Completion Visit: Month 2 for Cohort 1 and Month 1 for Cohort 2; Post-Treatment Follow-Up Visit: Month 3 for Cohort 1 and Month 2 for Cohort 2
Change in Low Luminance Questionnaire (LLQ) Composite Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Treatment Completion Visit: Month 2 for Cohort 1 and Month 1 for Cohort 2; Post-Treatment Follow-Up Visit: Month 3 for Cohort 1 and Month 2 for Cohort 2
Change in Low Luminance Questionnaire (LLQ) Driving Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Treatment Completion Visit: Month 2 for Cohort 1 and Month 1 for Cohort 2; Post-Treatment Follow-Up Visit: Month 3 for Cohort 1 and Month 2 for Cohort 2
Change in Low Luminance Questionnaire (LLQ) Extreme Lighting Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Participants with reticular pseudodrusen
Provide vitamin A to participants with pre/post assessments of vision.
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Pfau K, Jeffrey BG, Cukras CA. LOW-DOSE SUPPLEMENTATION WITH RETINOL IMPROVES RETINAL FUNCTION IN EYES WITH AGE-RELATED MACULAR DEGENERATION BUT WITHOUT RETICULAR PSEUDODRUSEN. Retina. 2023 Sep 1;43(9):1462-1471. doi: 10.1097/IAE.0000000000003840.
Emily Y Chew, M.D.
National Eye Institute (NEI)
9 participants (actual enrollment reported by the registry).
First Submitted
March 21, 2018
First Posted
March 27, 2018
Study Start
May 14, 2018
Actual (reported)Primary Completion
Treatment Completion Visit: Month 2 for Cohort 1 and Month 1 for Cohort 2; Post-Treatment Follow-Up Visit: Month 3 for Cohort 1 and Month 2 for Cohort 2
Contact the study team to confirm eligibility.
June 17, 2022
Actual (reported)Study Completion
June 17, 2022
Actual (reported)Last Updated
April 16, 2025
Results First Posted
July 3, 2024
Record last verified: 2023-12
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Source: ClinicalTrials.gov.
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