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Vitamin A Palmitate for Age-Related Macular Degeneration
Study Summary
This trial is testing whether taking vitamin A can improve vision in people with reticular pseudodrusen.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I had a YAG laser eye procedure within the last two months.I agree not to take more than 8,000 IU of vitamin A palmitate outside the study.I am currently participating in another research study and receiving treatment.I cannot follow the study's procedures or attend all visits.I haven't had major eye surgery in the last 3 months.I have an eye condition that could affect my vision during the study.I am taking vitamin A palmitate supplements of 8,000 IU or more.I have had hepatitis or liver failure in the past.I have a long-term stomach or intestine condition.I was in Cohort 1 and took vitamin A palmitate less than 2 months ago.I have had a vitamin A deficiency in the past.My liver function is normal or has only mild issues.I am 50 years old or older.I have advanced eye disease with severe vision loss or abnormal blood vessels.
- Group 1: Participants
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What health conditions are alleviated by Vitamin A Palmitate?
"Vitamin A Palmitate is typically used to combat Vitamin d deficiency, yet it can also be administered as a supplementary treatment for disease-related deficiencies of Vitamin A and overall nourishment."
What is the aggregate amount of individuals involved in this medical experiment?
"Affirmative. According to the clinicaltrials.gov database, this medical research project - which was initiated on May 14th 2018 - is now actively recruiting participants. There are 20 vacancies at a single site of enrolment."
Are there extant research projects investigating Vitamin A Palmitate?
"At present, there are 8 trials that investigate the efficacy of Vitamin A Palmitate. Two of these studies have reached Phase 3 while 13 medical centres across the United States are participating in its research. Massachusetts' Somerville has a particularly high concentration of clinical sites researching this medication."
Is enrollment for this experiment currently accessible?
"The available information on clinicaltrials.gov reveals that this medical study is currently accepting participants. The trial was originally posted back in May 14th 2018, with the most recent update taking place earlier this year in October 22nd 2022."
What are the primary aims of this medical experiment?
"As the primary endpoint of this trial, dark adaptation parameters will be tracked during a two month period. Additional secondary outcomes include changes in LLVA and patient reported findings collected via an LLQ questionnaire for Cohort 2. Moreover, AdaptDx measurements and Medmont data regarding thresholds and kinetics at Baseline and Month 2 are also considered as secondary endpoints for cohort 2 participants."
Is this an unprecedented clinical trial?
"At the moment, there are 8 active experiments that involve Vitamin A Palmitate in 10 cities across 2 nations. Alkeus Pharmaceuticals, Inc., launched the first trial for this drug back in 2015; it was a Phase two study with 140 participants. Since then, 31 studies have been completed successfully."
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