Vitamin A Palmitate Supplementation in People With Age-Related Macular Degeneration (and Without Reticular Pseudodrusen) and Delayed Dark Adaptation

Inclusion Criteria

• •Participant must be 50 years of age or older.
• •Participant must understand and sign the protocol s informed consent document.
• •Any participant of childbearing potential must be willing to undergo urine pregnancy tests throughout the study.
• •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 at least one acceptable method 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).
• •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.
• •Participant must agree to not take greater than or equal to 8000 IU vitamin A palmitate outside the study supplementation.
• •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).
• •Participant is in another investigational study and actively receiving study therapy.
• •Participant is unable to comply with study procedures or follow-up visits.
• •Participant is already taking vitamin A palmitate supplements greater than or equal to 8,000 IU.
• •Participant has a history of vitamin A deficiency.
• •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).
• •Participant has a history of hepatitis or liver failure.
• •Participant has chronic gastrointestinal disease.
• •Participant will be excluded if the participant has serologic evidence of an active hepatitis infection.
• •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 ELIGIBILITY CRITERIA:
• •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).
• •Participant must have at least one large druse.