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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
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( 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.


Condition or disease Intervention/treatment Phase
Reticular Pseudodrusen (RPD) Age-Related Macular Degeneration Drug: Vitamin A Palmitate Early Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Participants
Participants with reticular pseudodrusen
Drug: Vitamin A Palmitate
Provide vitamin A to participants with pre/post assessments of vision.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

To be eligible, the following inclusion criteria must be met, where applicable.

  1. Participant must be 50 years of age or older.
  2. Participant must understand and sign the protocol s informed consent document.
  3. Any participant of childbearing potential must be willing to undergo urine pregnancy tests throughout the study.
  4. Any participant of childbearing potential and any participant able to father children must have (or have a partner who has) had a hysterectomy or vasectomy, be completely abstinent from intercourse, or must agree to practice two acceptable methods of contraception throughout the course of the study and for one week after study supplement discontinuation. Acceptable methods of contraception include:

    • Hormonal contraception (i.e. birth control pills, injected hormones, dermal patch or vaginal ring),
    • Intrauterine device,
    • Barrier methods (diaphragm, condom) with spermicide, or
    • Surgical sterilization (tubal ligation).
  5. Participants must agree to notify the study investigator or coordinator if any of their doctors initiate a new prescription medication during the course of this study.
  6. Participant must agree to not take vitamin A palmitate greater than or equal to 8,000 IU outside the study supplementation.
  7. For supplementation eligibility, participant must have normal liver function as demonstrated by the Chemistry 20 panel, or have mild abnormalities not above grade 1 as defined by the Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
  8. Participant must not be pregnant or breast-feeding and must have a negative urine pregnancy test within 24 hours prior to initiation of study medication.

EXCLUSION CRITERIA:

A participant is not eligible if any of the following exclusion criteria are present.

  1. Participant is in another investigational study and actively receiving study therapy.
  2. Participant is unable to comply with study procedures or follow-up visits.
  3. Participant is already taking vitamin A palmitate supplements greater than or equal to 8,000 IU.
  4. Participant has a history of vitamin A deficiency.
  5. Participant has a condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control).
  6. Participant has a history of hepatitis or liver failure.
  7. Participant has chronic gastrointestinal disease.
  8. Participant will be excluded if the participant has serologic evidence of an active hepatitis infection.
  9. Participant was in Cohort 1 and took his/her last dose of vitamin A palmitate less than two months prior to enrolling in Cohort 2.

STUDY EYE INCLUSION CRITERIA:

  1. The eye must have a best-corrected ETDRS visual acuity score better than or equal to 20/80 (i.e., equal to or better than 54 letters).
  2. Participant must have presence of reticular pseudodrusen on multi-modal imaging.
  3. Abnormal dark adaptation, which is defined as having an AdaptDx 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.

STUDY EYE EXCLUSION CRITERIA:

  1. Presence of advanced macular degeneration with central geographic atrophy or choroidal neovascularization.
  2. An ocular condition is present (other than AMD) 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.).
  3. 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).
  4. History of major ocular surgery (e.g., cataract extraction, scleral buckle, any intraocular surgery, etc.) within three months prior to study entry.
  5. History of YAG (Yttrium-Aluminum Garnet) capsulotomy performed within two months prior to study entry.

CHOICE OF STUDY EYE IN CASES OF BILATERAL DISEASE:

If both eyes meet the study eye eligibility criteria described above, the following criteria will be used to select the study eye for the purposes of this investigation:

  1. The eye with the better visual acuity will be chosen.
  2. If both eyes are equal acuity, the right eye will be arbitrarily chosen as the study eye

Information from the National Library of Medicine

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


Contacts
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Contact: Angel H Garced, R.N. (301) 594-3141 garceda@nei.nih.gov
Contact: Catherine A Cukras, M.D. (301) 435-5061 cukrasc@mail.nih.gov

Locations
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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    prpl@cc.nih.gov   
Sponsors and Collaborators
National Eye Institute (NEI)
Investigators
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Principal Investigator: Catherine A Cukras, M.D. National Eye Institute (NEI)
Additional Information:
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Responsible Party: National Eye Institute (NEI)
ClinicalTrials.gov Identifier: NCT03478878    
Other Study ID Numbers: 180068
18-EI-0068
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: May 20, 2022
Last Verified: March 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) ):
Eye Examinations
Retinal Pigment Epithelium
Age-Related Macular Degeneration (AMD)
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Drusen
Retinal Degeneration
Retinal Diseases
Eye Diseases
Vitamin A
Retinol palmitate
Vitamins
Micronutrients
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents