Vitamin A Palmitate Supplementation in Patients With Reticular Pseudodrusen (RPD) and Delayed Dark Adaptation
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|ClinicalTrials.gov Identifier: NCT03478878|
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : May 20, 2022
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.
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.
Adults ages 50 and older with RPD and normal liver function
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
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.
|Condition or disease||Intervention/treatment||Phase|
|Reticular Pseudodrusen (RPD) Age-Related Macular Degeneration||Drug: Vitamin A Palmitate||Early Phase 1|
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 reticular pseudodrusen (RPD) and abnormal dark adaptation.
Study Population: The first cohort consists of seven participants with RPD who meet the eligibility criteria. The second cohort will consist of five participants with RPD 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 two months 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 pilot, uncontrolled, prospective, single center study to investigate the potential efficacy and safety of vitamin A palmitate dosing in improving dark adaptation in participants with RPD and abnormal dark adaptation. Participants in the first cohort were instructed to take 16,000 IU of vitamin A palmitate daily for two months. Participants in the second cohort will be instructed to take 48,000 IU of vitamin A palmitate daily for one month. Enrollment for Cohort 1 ended on January 10, 2019. 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 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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Investigation of Vitamin A Palmitate Supplementation in Patients With Reticular Pseudodrusen (RPD) and Delayed Dark Adaptation|
|Actual Study Start Date :||May 14, 2018|
|Estimated Primary Completion Date :||September 1, 2023|
|Estimated Study Completion Date :||September 1, 2023|
Participants with reticular pseudodrusen
Drug: Vitamin A Palmitate
Provide vitamin A to participants with pre/post assessments of vision.
- The measurement of dark adaptation parameters (threshold and kinetics) [ Time Frame: Baseline and Two months ]Measuring dark adaptation changes by AdaptDx and Medmont before and after vitamin A palmitate supplementation in Cohort 1.
- The measurement of dark adaptation parameters (threshold and kinetics) [ Time Frame: Baseline and One month ]Measuring dark adaptation changes by AdaptDx and Medmont before and after vitamin A palmitate supplementation in Cohort 2.
- Changes in LLVA and LLQ [ Time Frame: Baseline and two months, baseline and three months ]Changes in LLVA and patient reported outcomes measured by LLQ for Cohort 1
- Changes in LLVA and LLQ [ Time Frame: Baseline and one month, baseline and two months ]Changes and patient reported outcomes measured by LLQ in LLVA for Cohort 2
- Changes in dark adaptation measures by AdaptDx and Medmont [ Time Frame: Baseline and one month after completing supplementation ]Dark adaptation parameters (threshold and kinetics) comparing baseline and one month after completing supplementation (Month 3 in Cohort 1 and Month 2 in Cohort 2)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03478878
|Contact: Angel H Garced, R.N.||(301) email@example.com|
|Contact: Catherine A Cukras, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Catherine A Cukras, M.D.||National Eye Institute (NEI)|