Vitamin A Palmitate Supplementation in Patients With Reticular Pseudodrusen (RPD) and Delayed Dark Adaptation
- Conditions
- Reticular Pseudodrusen (RPD)Age-Related Macular Degeneration
- Interventions
- Registration Number
- NCT03478878
- Lead Sponsor
- National Eye Institute (NEI)
- Brief 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 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.
- Detailed 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 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Participants Vitamin A Palmitate Participants with reticular pseudodrusen
- Primary Outcome Measures
Name Time Method 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) Baseline to Month 2 for Cohort 1 and Baseline to 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%.
- Secondary Outcome Measures
Name Time Method Change in Low Luminance Questionnaire (LLQ) Emotional Distress 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 Low Luminance Questionnaire (LLQ) is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Individual questions are assigned to one of six distinct subscales and are scored in 25-point increments (range=0 to 100, higher values=better outcome). Applicable questions are averaged to produce (weighted) subscale scores (range=0 to 100, higher values=better outcome). The mean change in LLQ emotional distress subscale score from baseline at the treatment completion and post-treatment completion visits are descriptively summarized. A positive score change represents improvement in functioning from baseline (i.e., higher values=better outcome), whereas a negative score change represents a decline in functioning from baseline (i.e., lower values=worse outcome).
Change in Low Luminance Questionnaire (LLQ) General Dim Lighting 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 Low Luminance Questionnaire (LLQ) is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Individual questions are assigned to one of six distinct subscales and are scored in 25-point increments (range=0 to 100, higher values=better outcome). Applicable questions are averaged to produce (weighted) subscale scores (range=0 to 100, higher values=better outcome). The mean change in LLQ general dim lighting subscale score from baseline at the treatment completion and post-treatment completion visits are descriptively summarized. A positive score change represents improvement in functioning from baseline (i.e., higher values=better outcome), whereas a negative score change represents a decline in functioning from baseline (i.e., lower values=worse outcome).
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 The mean change in rod intercept time (RIT) in the study eye at the post-treatment follow-up 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%.
Change in Low Luminance Questionnaire (LLQ) Extreme Lighting 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 Low Luminance Questionnaire (LLQ) is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Individual questions are assigned to one of six distinct subscales and are scored in 25-point increments (range=0 to 100, higher values=better outcome). Applicable questions are averaged to produce (weighted) subscale scores (range=0 to 100, higher values=better outcome). The mean change in LLQ extreme lighting subscale score from baseline at the treatment completion and post-treatment completion visits are descriptively summarized. A positive score change represents improvement in functioning from baseline (i.e., higher values=better outcome), whereas a negative score change represents a decline in functioning from baseline (i.e., lower values=worse outcome).
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 The mean change in low luminance visual acuity (LLVA) in the study eye from baseline at the treatment completion and post-treatment follow-up visits were descriptively summarized.
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 Low Luminance Questionnaire (LLQ) is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Individual questions are assigned to one of six distinct subscales and are scored in 25-point increments (range=0 to 100, higher values=better outcome). Applicable questions are averaged to produce (weighted) subscale scores (range=0 to 100, higher values=better outcome). (Weighted) Subscale scores are averaged to produce a composite score (range=0 to 100, higher values=better outcome). The mean change in LLQ composite score from baseline at the treatment completion and post-treatment completion visits are descriptively summarized. A positive score change represents improvement in functioning from baseline (i.e., higher values=better outcome), whereas a negative score change represents a decline in functioning from baseline (i.e., lower values=worse outcome).
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 Low Luminance Questionnaire (LLQ) is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Individual questions are assigned to one of six distinct subscales and are scored in 25-point increments (range=0 to 100, higher values=better outcome). Applicable questions are averaged to produce (weighted) subscale scores (range=0 to 100, higher values=better outcome). The mean change in LLQ driving subscale score from baseline at the treatment completion and post-treatment completion visits are descriptively summarized. A positive score change represents improvement in functioning from baseline (i.e., higher values=better outcome), whereas a negative score change represents a decline in functioning from baseline (i.e., lower values=worse outcome).
Change in Low Luminance Questionnaire (LLQ) Mobility 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 Low Luminance Questionnaire (LLQ) is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Individual questions are assigned to one of six distinct subscales and are scored in 25-point increments (range=0 to 100, higher values=better outcome). Applicable questions are averaged to produce (weighted) subscale scores (range=0 to 100, higher values=better outcome). The mean change in LLQ mobility subscale score from baseline at the treatment completion and post-treatment completion visits are descriptively summarized. A positive score change represents improvement in functioning from baseline (i.e., higher values=better outcome), whereas a negative score change represents a decline in functioning from baseline (i.e., lower values=worse outcome).
Change in Low Luminance Questionnaire (LLQ) Peripheral Vision 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 Low Luminance Questionnaire (LLQ) is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Individual questions are assigned to one of six distinct subscales and are scored in 25-point increments (range=0 to 100, higher values=better outcome). Applicable questions are averaged to produce (weighted) subscale scores (range=0 to 100, higher values=better outcome). The mean change in LLQ peripheral vision subscale score from baseline at the treatment completion and post-treatment completion visits are descriptively summarized. A positive score change represents improvement in functioning from baseline (i.e., higher values=better outcome), whereas a negative score change represents a decline in functioning from baseline (i.e., lower values=worse outcome).
Trial Locations
- Locations (1)
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States