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

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ClinicalTrials.gov Identifier: NCT03478865
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : July 4, 2018
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 the eye to adjust to low light. This is known as dark adaptation. Identifying and watching the early to middle stages of AMD and changes in dark adaptation might help researchers develop new treatments to stop the disease before it becomes severe. Taking vitamin A might help improve vision in people with AMD.

Objectives:

To see if taking 16,000 IU of vitamin A per day improves vision in people with AMD. Also to improve understanding of AMD and associated dark adaptation.

Eligibility:

Adults ages 50 and older with AMD 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. 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 30 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
AMD Drug: Vitamin A palmitate Early Phase 1

Detailed Description:

Objective: The objective of this study is to investigate the potential efficacy of vitamin A palmitate in improving dark adaptation in participants with age-related macular degeneration (AMD) and abnormal dark adaptation.

Study Population: Five participants will be initially accrued, however, up to ten participants with AMD who meet the eligibility criteria may be enrolled. In the event that a participant withdraws from the study prior to receiving two months of study supplementation for a reason unrelated to an adverse reaction, an additional participant will be accrued. A maximum of five additional participants may be accrued in order to obtain five participants for the primary outcome analysis.

Design: This is a pilot, uncontrolled, prospective, single center study to investigate the potential efficacy of vitamin A palmitate in improving dark adaptation in participants with AMD and abnormal dark adaptation.

Outcome Measures: 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 supplementation and dark adaptation parameters as measured by the Medmont comparing before and after vitamin A palmitate supplementation. The secondary outcomes are changes in low luminance visual acuity (LLVA) and changes in patient reported outcomes as measured by the low luminance questionnaire (LLQ).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Vitamin A Palmitate Supplementation in Patients With Age-Related Macular Degeneration (and Without Reticular Pseudodrusen) and Delayed Dark Adaptation
Actual Study Start Date : April 20, 2018
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : August 22, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Supplementation Drug: Vitamin A palmitate
vitamin A palmitate 16,000 IU daily by mouth for two months




Primary Outcome Measures :
  1. Measurement of dark adaptation as measured by AdaptDX and Medmont comparing pre- and post-vitamin A palmitate supplementation. [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Changes in LLVA and changes in patient reported outcomes as measured by the LLQ. [ Time Frame: 90 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.

  • 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 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).
  • 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).

EXCLUSION CRITERIA:

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

  • 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.
  • 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.

STUDY EYE ELIGIBILITY CRITERIA:

The participant must have at least one eye meeting all inclusion criteria and none of the exclusion criteria listed below.

STUDY EYE INCLUSION CRITERIA:

  • The eye must have a best-corrected ETDRS visual acuity score better than or equal to 20/80 (i.e., better than 54 letters).
  • Participant must have at least one large druse.
  • Abnormal dark adaptation, which is defined as having an Adapt Dx test with a RIT of 18 minutes or more at the screening visit. This is at least one standard deviation greater than the average normal RIT.

STUDY EYE EXCLUSION CRITERIA:

  • Presence of advanced macular degeneration with central geographic atrophy or choroidal neovascularization.
  • Presence of definite reticular pseudodrusen.
  • An ocular condition is present (other than retinal vein occlusion) 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.).
  • 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).
  • History of major ocular surgery (e.g. cataract extraction, scleral buckle, any intraocular surgery, etc.) within three months prior to study entry.
  • History of YAG (Yttrium-Aluminum Garnet) capsulotomy performed within two months prior to study entry.

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): NCT03478865


Contacts
Contact: Angel H Garced, R.N. (301) 594-3141 garceda@nei.nih.gov

Locations
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
Principal Investigator: Catherine A Cukras, M.D. National Eye Institute (NEI)

Additional Information:
Responsible Party: National Eye Institute (NEI)
ClinicalTrials.gov Identifier: NCT03478865     History of Changes
Other Study ID Numbers: 180067
18-EI-0067
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: July 4, 2018
Last Verified: April 10, 2018

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

Additional relevant MeSH terms:
Retinal Diseases
Macular Degeneration
Retinal Degeneration
Eye Diseases
Vitamins
Vitamin A
Retinol palmitate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents