An Early Phase 1 interventional study of Vitamin A palmitate in AMD, sponsored by National Eye Institute (NEI). Completed at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-04-15.
Sponsored by National Eye Institute (NEI) · Early Phase 1, Interventional, and Treatment
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.
Objective:
The objective of this study is to investigate the potential efficacy and safety of vitamin A palmitate dosing in improving dark adaptation in participants with age-related macular degeneration (AMD) and abnormal dark adaptation.
Study Population:
The first cohort consists of five participants with AMD who meet the eligibility criteria. The second cohort will consist of five participants with AMD who meet the eligibility criteria. Up to five additional participants may be accrued in the second cohort to account for participants who withdraw from the study prior to receiving one month of study supplementation for a reason unrelated to an adverse reaction. Up to 18 participants may be enrolled in this study.
Design:
This is a prospective, uncontrolled, single center, pilot study to investigate the potential efficacy and safety of vitamin A palmitate dosing in improving dark adaptation in participants with AMD and abnormal dark adaptation. Participants in the first cohort were instructed to take 16,000 IU of vitamin A palmitate daily for two months. Enrollment for Cohort 1 ended on May 24, 2019. Participants in the second cohort will be instructed to take 48,000 IU of vitamin A palmitate daily for one month. Participants in both cohorts will continue in the study for one month after ending Vitamin A supplementation. Participants in Cohort 1 may enroll into Cohort 2 as long as their last intake of vitamin A palmitate was greater than two months prior to their enrollment into Cohort 2.
Outcome Measures:
For each cohort, 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 primary outcome will be assessed at Month 2 in the first cohort and Month 1 in the second cohort. For both cohorts, the secondary outcomes include changes in low luminance visual acuity (LLVA) and changes in patient reported outcomes as measured by the low luminance questionnaire (LLQ). The secondary outcomes also include measurement of dark adaptation parameters (thresholds and kinetics) comparing baseline and one month after completing supplementation (Month 3 in Cohort 1 and Month 2 in Cohort 2).
National Eye Institute (NEI) is the lead sponsor of 272 studies on the registry; 17 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 8 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
To be eligible, the following inclusion criteria must be met, where applicable.
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 throughout the course of the study and for one week after study supplement discontinuation. Acceptable methods of contraception include:
EXCLUSION CRITERIA:
A participant is not eligible if any of the following exclusion criteria are present:
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:
STUDY EYE EXCLUSION CRITERIA:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with age-related macular degeneration
Drug: Vitamin A palmitate
Provide vitamin A to participants with pre/post assessments of vision.
Change in Dark Adaptation Rod Intercept Time (RIT) From Baseline in the Study Eye at the Treatment Completion Visit (Month 2 for Cohort 1 and Month 1 for Cohort 2)
The mean change in rod intercept time (RIT) in the study eye at the treatment completion visit from baseline was descriptively summarized and assessed using a Student's paired t-test at a two-sided Type I error rate of 5%.
Time frame: Baseline to Month 2 for Cohort 1 and Baseline to Month 1 for Cohort 2
Change in Dark Adaptation Rod Intercept Time (RIT) From Baseline in the Study Eye at the Post-Treatment Follow-Up Visit (Month 3 for Cohort 1 and Month 2 for Cohort 2).
The mean change in rod intercept time (RIT) in the study eye at the post-treatment follow-up visit from baseline was descriptively summarized and assessed using a Student's paired t-test at a two-sided Type I error rate of 5%.
Time frame: Baseline to Month 3 for Cohort 1 and Baseline to Month 2 for Cohort 2
Change in Low Luminance Visual Acuity (LLVA) From Baseline in the Study Eye at the Treatment Completion and Post-Treatment Follow-Up Visits
The mean change in low luminance visual acuity (LLVA) in the study eye from baseline at the treatment completion and post-treatment follow-up visits were descriptively summarized.
Time frame: Treatment Completion Visit: Month 2 for Cohort 1 and Month 1 for Cohort 2; Post-Treatment Follow-Up Visit: Month 3 for Cohort 1 and Month 2 for Cohort 2
Change in Low Luminance Questionnaire (LLQ) Composite Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
The mean change in low luminance questionnaire (LLQ) composite score from baseline at the treatment completion and post-treatment completion visits were descriptively summarized. LLQ is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Questions are scored on a range from 0 (indicative of maximum difficulty) to 100 (indicative of no difficulty) in 25 point increments where higher scores indicate better functioning. Each question is assigned to one of six distinct subscales. Applicable questions are averaged to produce (weighted) subscale scores; (weighted) subscale scores are averaged to produce a composite score.
Time frame: Treatment Completion Visit: Month 2 for Cohort 1 and Month 1 for Cohort 2; Post-Treatment Follow-Up Visit: Month 3 for Cohort 1 and Month 2 for Cohort 2
Change in Low Luminance Questionnaire (LLQ) Driving Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
The mean change in low luminance questionnaire (LLQ) driving subscale score from baseline at the treatment completion and post-treatment completion visits were descriptively summarized. LLQ is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Questions are scored on a range from 0 (indicative of maximum difficulty) to 100 (indicative of no difficulty) in 25 point increments where higher scores indicate better functioning. Each question is assigned to one of six distinct subscales. Applicable questions are averaged to produce (weighted) subscale scores.
Time frame: Treatment Completion Visit: Month 2 for Cohort 1 and Month 1 for Cohort 2; Post-Treatment Follow-Up Visit: Month 3 for Cohort 1 and Month 2 for Cohort 2
Change in Low Luminance Questionnaire (LLQ) Extreme Lighting Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
The mean change in low luminance questionnaire (LLQ) extreme lighting subscale score from baseline at the treatment completion and post-treatment completion visits were descriptively summarized. LLQ is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Questions are scored on a range from 0 (indicative of maximum difficulty) to 100 (indicative of no difficulty) in 25 point increments where higher scores indicate better functioning. Each question is assigned to one of six distinct subscales. Applicable questions are averaged to produce (weighted) subscale scores.
Time frame: Treatment Completion Visit: Month 2 for Cohort 1 and Month 1 for Cohort 2; Post-Treatment Follow-Up Visit: Month 3 for Cohort 1 and Month 2 for Cohort 2
Change in Low Luminance Questionnaire (LLQ) Mobility Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
The mean change in low luminance questionnaire (LLQ) mobility subscale score from baseline at the treatment completion and post-treatment completion visits were descriptively summarized. LLQ is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Questions are scored on a range from 0 (indicative of maximum difficulty) to 100 (indicative of no difficulty) in 25 point increments where higher scores indicate better functioning. Each question is assigned to one of six distinct subscales. Applicable questions are averaged to produce (weighted) subscale scores.
Time frame: Treatment Completion Visit: Month 2 for Cohort 1 and Month 1 for Cohort 2; Post-Treatment Follow-Up Visit: Month 3 for Cohort 1 and Month 2 for Cohort 2
Change in Low Luminance Questionnaire (LLQ) Emotional Distress Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
The mean change in low luminance questionnaire (LLQ) emotional distress subscale score from baseline at the treatment completion and post-treatment completion visits were descriptively summarized. LLQ is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Questions are scored on a range from 0 (indicative of maximum difficulty) to 100 (indicative of no difficulty) in 25 point increments where higher scores indicate better functioning. Each question is assigned to one of six distinct subscales. Applicable questions are averaged to produce (weighted) subscale scores.
Time frame: Treatment Completion Visit: Month 2 for Cohort 1 and Month 1 for Cohort 2; Post-Treatment Follow-Up Visit: Month 3 for Cohort 1 and Month 2 for Cohort 2
Change in Low Luminance Questionnaire (LLQ) General Dim Lighting Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
The mean change in low luminance questionnaire (LLQ) general dim lighting subscale score from baseline at the treatment completion and post-treatment completion visits were descriptively summarized. LLQ is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Questions are scored on a range from 0 (indicative of maximum difficulty) to 100 (indicative of no difficulty) in 25 point increments where higher scores indicate better functioning. Each question is assigned to one of six distinct subscales. Applicable questions are averaged to produce (weighted) subscale scores.
Time frame: Treatment Completion Visit: Month 2 for Cohort 1 and Month 1 for Cohort 2; Post-Treatment Follow-Up Visit: Month 3 for Cohort 1 and Month 2 for Cohort 2
Change in Low Luminance Questionnaire (LLQ) Peripheral Vision Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
The mean change in low luminance questionnaire (LLQ) peripheral vision subscale score from baseline at the treatment completion and post-treatment completion visits were descriptively summarized. LLQ is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Questions are scored on a range from 0 (indicative of maximum difficulty) to 100 (indicative of no difficulty) in 25 point increments where higher scores indicate better functioning. Each question is assigned to one of six distinct subscales. Applicable questions are averaged to produce (weighted) subscale scores.
Time frame: Treatment Completion Visit: Month 2 for Cohort 1 and Month 1 for Cohort 2; Post-Treatment Follow-Up Visit: Month 3 for Cohort 1 and Month 2 for Cohort 2
Up to eighteen (18) participants (8 participants in Cohort 1 and up to 10 participants in Cohort 2) with age-related macular degeneration (AMD) and abnormal dark adaptation may be enrolled. At the National Eye Institute, enrollment for Cohort 1 closed on May 24, 2019 and enrollment for Cohort 2 was suspended on August 31, 2023.
| Milestone | Cohort 1 | Cohort 2 |
|---|---|---|
| Started | 5 | 3 |
| Completed treatment completion visit | 5 | 3 |
| Completed | 5 | 3 |
| Not completed | 0 | 0 |
The mean change in rod intercept time (RIT) in the study eye at the treatment completion visit from baseline was descriptively summarized and assessed using a Student's paired t-test at a two-sided Type I error rate of 5%.
| Minutes | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline Visit | 25.12 ± 10.755 | 20.03 ± 6.793 |
| Treatment Completion Visit | 22.58 ± 8.219 | 19.77 ± 7.753 |
| Change from Baseline at the Treatment Completion Visit | -2.54 ± 4.322 | -0.27 ± 1.767 |
The mean change in rod intercept time (RIT) in the study eye at the post-treatment follow-up visit from baseline was descriptively summarized and assessed using a Student's paired t-test at a two-sided Type I error rate of 5%.
| minutes | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline Visit | 25.12 ± 10.755 | 20.03 ± 6.793 |
| Post-Treatment Follow-Up Visit | 21.56 ± 6.271 | 23.27 ± 12.847 |
| Change from Baseline at the Post-Treatment Follow-Up Visit | -3.56 ± 7.793 | 3.23 ± 6.512 |
The mean change in low luminance visual acuity (LLVA) in the study eye from baseline at the treatment completion and post-treatment follow-up visits were descriptively summarized.
| letters read | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline Visit | 66.8 ± 16.22 | 56.3 ± 16.17 |
| Treatment Completion Visit | 71.6 ± 11.41 | 59.3 ± 16.01 |
| Change from Baseline at the Treatment Completion Visit | 4.8 ± 17.31 | 3.0 ± 1.73 |
| Post-Treatment Follow-Up Visit | 69.8 ± 6.69 | 59.3 ± 17.01 |
| Change from Baseline at the Post-Treatment Follow-Up Visit | 3.0 ± 14.88 | 3.0 ± 2.00 |
The mean change in low luminance questionnaire (LLQ) composite score from baseline at the treatment completion and post-treatment completion visits were descriptively summarized. LLQ is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Questions are scored on a range from 0 (indicative of maximum difficulty) to 100 (indicative of no difficulty) in 25 point increments where higher scores indicate better functioning. Each question is assigned to one of six distinct subscales. Applicable questions are averaged to produce (weighted) subscale scores; (weighted) subscale scores are averaged to produce a composite score.
| score on a scale | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline Visit | 86.35 ± 17.521 | 86.79 ± 11.431 |
| Treatment Completion Visit | 87.38 ± 17.420 | 86.13 ± 9.958 |
| Post-Treatment Follow-Up Visit | 84.83 ± 19.142 | 88.73 ± 7.382 |
| Change from Baseline at the Treatment Completion Visit | 1.03 ± 1.087 | -0.66 ± 2.815 |
| Change from Baseline at the Post-Treatment Follow-Up Visit | -1.51 ± 3.283 | 1.93 ± 5.435 |
The mean change in low luminance questionnaire (LLQ) driving subscale score from baseline at the treatment completion and post-treatment completion visits were descriptively summarized. LLQ is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Questions are scored on a range from 0 (indicative of maximum difficulty) to 100 (indicative of no difficulty) in 25 point increments where higher scores indicate better functioning. Each question is assigned to one of six distinct subscales. Applicable questions are averaged to produce (weighted) subscale scores.
| score on a scale | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline Visit | 86.00 ± 20.433 | 68.33 ± 37.859 |
| Treatment Completion Visit | 87.00 ± 17.889 | 55.00 ± 36.056 |
| Post-Treatment Follow-Up Visit | 84.00 ± 22.192 | 63.33 ± 33.292 |
| Change from Baseline at the Treatment Completion Visit | 1.00 ± 8.944 | -13.33 ± 5.774 |
| Change from Baseline at the Post-Treatment Follow-Up Visit | -2.00 ± 4.472 | -5.00 ± 5.000 |
The mean change in low luminance questionnaire (LLQ) extreme lighting subscale score from baseline at the treatment completion and post-treatment completion visits were descriptively summarized. LLQ is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Questions are scored on a range from 0 (indicative of maximum difficulty) to 100 (indicative of no difficulty) in 25 point increments where higher scores indicate better functioning. Each question is assigned to one of six distinct subscales. Applicable questions are averaged to produce (weighted) subscale scores.
| score on a scale | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline Visit | 81.25 ± 18.880 | 73.96 ± 26.578 |
| Treatment Completion Visit | 84.38 ± 20.492 | 77.08 ± 25.259 |
| Post-Treatment Follow-Up Visit | 78.75 ± 20.420 | 80.83 ± 12.521 |
| Change from Baseline at the Treatment Completion Visit | 3.13 ± 5.846 | 3.13 ± 5.413 |
| Change from Baseline at the Post-Treatment Follow-Up Visit | -2.50 ± 6.775 | 6.88 ± 26.612 |
The mean change in low luminance questionnaire (LLQ) mobility subscale score from baseline at the treatment completion and post-treatment completion visits were descriptively summarized. LLQ is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Questions are scored on a range from 0 (indicative of maximum difficulty) to 100 (indicative of no difficulty) in 25 point increments where higher scores indicate better functioning. Each question is assigned to one of six distinct subscales. Applicable questions are averaged to produce (weighted) subscale scores.
| score on a scale | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline Visit | 88.33 ± 16.245 | 96.53 ± 3.182 |
| Treatment Completion Visit | 90.00 ± 14.006 | 97.22 ± 2.406 |
| Post-Treatment Follow-Up Visit | 88.33 ± 15.975 | 97.22 ± 2.406 |
| Change from Baseline at the Treatment Completion Visit | 1.67 ± 2.282 | 0.69 ± 5.243 |
| Change from Baseline at the Post-Treatment Follow-Up Visit | 0.00 ± 2.946 | 0.69 ± 5.243 |
The mean change in low luminance questionnaire (LLQ) emotional distress subscale score from baseline at the treatment completion and post-treatment completion visits were descriptively summarized. LLQ is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Questions are scored on a range from 0 (indicative of maximum difficulty) to 100 (indicative of no difficulty) in 25 point increments where higher scores indicate better functioning. Each question is assigned to one of six distinct subscales. Applicable questions are averaged to produce (weighted) subscale scores.
| score on a scale | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline Visit | 95.00 ± 8.149 | 97.22 ± 4.811 |
| Treatment Completion Visit | 93.75 ± 10.825 | 95.14 ± 4.337 |
| Post-Treatment Follow-Up Visit | 93.75 ± 10.825 | 97.92 ± 3.608 |
| Change from Baseline at the Treatment Completion Visit | -1.25 ± 2.795 | -2.08 ± 3.608 |
| Change from Baseline at the Post-Treatment Follow-Up Visit | -1.25 ± 2.795 | 0.69 ± 1.203 |
The mean change in low luminance questionnaire (LLQ) general dim lighting subscale score from baseline at the treatment completion and post-treatment completion visits were descriptively summarized. LLQ is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Questions are scored on a range from 0 (indicative of maximum difficulty) to 100 (indicative of no difficulty) in 25 point increments where higher scores indicate better functioning. Each question is assigned to one of six distinct subscales. Applicable questions are averaged to produce (weighted) subscale scores.
| score on a scale | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline Visit | 82.50 ± 26.087 | 90.28 ± 2.406 |
| Treatment Completion Visit | 84.17 ± 24.008 | 95.14 ± 4.337 |
| Post-Treatment Follow-Up Visit | 82.50 ± 25.069 | 93.06 ± 6.365 |
| Change from Baseline at the Treatment Completion Visit | 1.67 ± 2.282 | 4.86 ± 4.337 |
| Change from Baseline at the Post-Treatment Follow-Up Visit | 0.00 ± 2.946 | 2.78 ± 4.811 |
The mean change in low luminance questionnaire (LLQ) peripheral vision subscale score from baseline at the treatment completion and post-treatment completion visits were descriptively summarized. LLQ is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Questions are scored on a range from 0 (indicative of maximum difficulty) to 100 (indicative of no difficulty) in 25 point increments where higher scores indicate better functioning. Each question is assigned to one of six distinct subscales. Applicable questions are averaged to produce (weighted) subscale scores.
| score on a scale | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline Visit | 85.00 ± 22.361 | 94.44 ± 9.623 |
| Treatment Completion Visit | 85.00 ± 22.361 | 97.22 ± 4.811 |
| Post-Treatment Follow-Up Visit | 81.67 ± 25.276 | 100.00 ± 0.000 |
| Change from Baseline at the Treatment Completion Visit | 0.00 ± 0.000 | 2.78 ± 4.811 |
| Change from Baseline at the Post-Treatment Follow-Up Visit | -3.33 ± 7.454 | 5.56 ± 9.623 |
Collected over Participants enrolled are assessed for AEs starting at Baseline through study completion (Month 3 for Cohort 1 and Month 2 for Cohort 2).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cohort 1 | 0/5 (0%) | 0/5 (0%) | 2/5 (40%) |
| Cohort 2 | 0/3 (0%) | 0/3 (0%) | 2/3 (66.7%) |
| Event | Cohort 1 | Cohort 2 |
|---|---|---|
| CataractEye disorders | 0/5 | 1/3 |
| NauseaGastrointestinal disorders | 0/5 | 1/3 |
| SwellingGeneral disorders | 0/5 | 1/3 |
| Blood uric acid increasedInvestigations | 0/5 | 1/3 |
| MyalgiaMusculoskeletal and connective tissue disorders | 0/5 | 1/3 |
| Prostatic massReproductive system and breast disorders | 0/5 | 1/3 |
| Eye irritationEye disorders | 1/5 | 0/3 |
| Lacrimal disorderEye disorders | 1/5 | 0/3 |
| Blood pressure increasedInvestigations | 1/5 | 0/3 |
| Visual ImpairmentEye disorders | 1/5 | 0/3 |
| Age, Categorical(Participants) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 5 | 3 | 8 |
| Age, Continuous(years) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Median | 78.0 ± 4.74 | 80.0 ± 7.00 | 78.8 ± 5.28 |
| Sex: Female, Male(Participants) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Female | 2 | 1 | 3 |
| Male | 3 | 2 | 5 |
| Ethnicity (NIH/OMB)(Participants) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 5 | 3 | 8 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 5 | 3 | 8 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| United States | 5 | 3 | 8 |
| Dark Adaptation Rod Intercept Time(minutes) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Mean | 25.12 ± 10.755 | 20.03 ± 6.793 | 23.21 ± 9.285 |
| Low Luminance Visual Acuity (LLVA) Total Letters Read(letters read) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Mean | 66.8 ± 16.22 | 56.3 ± 16.17 | 62.9 ± 15.95 |
7 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Apr 2018 to primary completion in Jun 2023, 61 months.
Results were first posted in May 2024, 11 months after primary completion.
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Studies of the drug tested here: Retinol palmitate
National Eye Institute (NEI) →