Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03478878
Recruitment Status : Recruiting
First Posted : March 27, 2018
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) )

Tracking Information
First Submitted Date  ICMJE March 21, 2018
First Posted Date  ICMJE March 27, 2018
Last Update Posted Date March 11, 2019
Actual Study Start Date  ICMJE May 14, 2018
Estimated Primary Completion Date January 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2018)
Measurement of change in dark adaptation times as measured by the AdaptDx and Medmont pre-and post-vitamin A palmitate supplementation. [ Time Frame: 90 Days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03478878 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2018)
Changes in LLVA and changes in patient reported outcomes as measured by the LLQ. [ Time Frame: 90 Days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin A Palmitate Supplementation in Patients With Reticular Pseudodrusen (RPD) and Delayed Dark Adaptation
Official Title  ICMJE An Investigation of Vitamin A Palmitate Supplementation in Patients With Reticular Pseudodrusen (RPD) and Delayed Dark Adaptation
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.

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 reticular pseudodrusen (RPD) and abnormal dark adaptation.

Study Population: Ten participants will be initially accrued, however, up to twenty participants with RPD 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 ten additional participants may be accrued in order to obtain ten 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 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  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Reticular Pseudodrusen (RPD)
  • Age-Related Macular Degeneration (AMD)
Intervention  ICMJE Drug: Vitamin A Palmitate
Softgels
Study Arms  ICMJE Experimental: Supplementation
Experimental
Intervention: Drug: Vitamin A Palmitate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 24, 2018)
20
Original Estimated Enrollment  ICMJE
 (submitted: March 24, 2018)
10
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date January 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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.

STUDY EYE INCLUSION CRITERIA:

The participant must have at least one eye meeting all 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:

The participant must have none of the exclusion criteria listed below

  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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Angel H Garced, R.N. (301) 594-3141 garceda@nei.nih.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03478878
Other Study ID Numbers  ICMJE 180068
18-EI-0068
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Eye Institute (NEI) )
Study Sponsor  ICMJE National Eye Institute (NEI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Catherine A Cukras, M.D. National Eye Institute (NEI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date March 4, 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP