Vitamin A Palmitate Supplementation in Patients With Reticular Pseudodrusen (RPD) and Delayed Dark Adaptation

• 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 pregnancytests throughout the study.

4. Any participant of childbearing potential and any participant able to fatherchildren must have (or have a partner who has) had a hysterectomy or vasectomy, becompletely abstinent from intercourse, or must agree to practice at least oneacceptable method of contraception throughout the course of the study and for oneweek after study supplement discontinuation. Acceptable methods of contraceptioninclude:

• Hormonal contraception (i.e. birth control pills, injected hormones, dermalpatch 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 oftheir doctors initiate a new prescription medication during the course of thisstudy.

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 asdemonstrated by the Chemistry 20 panel, or have mild abnormalities not above grade 1as 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 urinepregnancy 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 studytherapy.

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 equalto 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 precludeparticipation in the study (e.g., unstable medical status including blood pressureand 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 activehepatitis infection.

9. Participant was in Cohort 1 and took his/her last dose of vitamin A palmitate lessthan 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 deviationgreater than the average normal RIT and includes room to account for variability intesting. If at any point during current testing or under a previous NEI protocol, aparticipant has exceeded the 40 minute test ceiling, they will have satisfied theinclusion criteria.

STUDY EYE EXCLUSION CRITERIA:

1. Presence of advanced macular degeneration with central geographic atrophy orchoroidal neovascularization.

2. An ocular condition is present (other than AMD) that, in the opinion of theinvestigator, might alter visual acuity during the course of the study (e.g., veinocclusion, 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 bedecreasing visual acuity by three lines or more (i.e., cataract would be reducingacuity to 20/40 or worse if eye was otherwise normal).

4. History of major ocular surgery (e.g., cataract extraction, scleral buckle, anyintraocular surgery, etc.) within three months prior to study entry.

5. History of YAG (Yttrium-Aluminum Garnet) capsulotomy performed within two monthsprior 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 studyeye