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Protocol Details

An Investigation of Vitamin A Palmitate Supplementation in Patients with Reticular Pseudodrusen (RPD) and Delayed Dark Adaptation

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

18-EI-0068

Sponsoring Institute

National Eye Institute (NEI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 50 Years
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Eye Examinations;
Retinal Pigment Epithelium;
Age Related Macular Degeneration

Recruitment Keyword(s)

None

Condition(s)

Reticular Pseudodrusen (RPD);
Age-Related Macular Degeneration (AMD)

Investigational Drug(s)

Vitamin A Palmitate Softgels

Investigational Device(s)

None

Intervention(s)

Drug: Vitamin A Palmitate

Supporting Site

National Eye Institute

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.

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Eligibility

INCLUSION CRITERIA - PARTICIPANT:

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 - PARTICIPANT:

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


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Catherine A. Cukras, M.D.
National Eye Institute (NEI)



Angel H. Garced, R.N.
National Eye Institute (NEI)
National Institutes of Health
Building 10
Room 10D45
10 Center Drive
Bethesda, Maryland 20892
(301) 594-3141
garceda@nei.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT03478878

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