An Early Phase 1 interventional study of Vitamin A Palmitate in Reticular Pseudodrusen (RPD) and Age-Related Macular Degeneration, 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 2025-04-16.
Sponsored by National Eye Institute (NEI) · Early Phase 1, Interventional, and Treatment
Among 55 studies in Macular Degeneration by National Eye Institute (NEI) — 3 open to participants now, 4 under way, none of them phase 3. Macular Degeneration · National Eye Institute (NEI).
Among the 55 studies in Macular Degeneration by National Eye Institute (NEI), this one is the 20th largest by enrollment of the 23 interventional ones that give a count, is one of 2 that started in 2018, is one of 9 in phase 1, and was the 54th registered.
1,459 studies on the registry are indexed under Macular Degeneration; 238 are open to participants now.
Browse Macular Degeneration studies →3 of the 55 studies in Macular Degeneration by National Eye Institute (NEI) are open now, in 1 country. Recruiting first, the newest first:
National Eye Institute (NEI) · Sites in United States
Ages 10–100
National Eye Institute (NEI) · Sites in United States
Ages 2–120 · Healthy volunteers
National Eye Institute (NEI) · Sites in United States
Ages 1 days–120 yrs · Healthy volunteers
By country, each count listing its studies:
Of the 166 Macular Degeneration studies recruiting now, 117 (70%) set no upper age limit and 5 (3%) stop at 75 or younger; 19 take children under 18; 35 take healthy volunteers.
This study: 50 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
55 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 12 · Phase 2 9 · Phase 3 10
First in 1977; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 9 is below the median of 56 across 985 interventional studies indexed under Macular Degeneration.
Median enrollment 30 across the 23 interventional studies, 150 across the 27 observational. Of the 48 that completed or were terminated, 7 (15%) have results posted.
This tab as a report to print or save as PDF → With an account.
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.
None of the studies under way reaches primary completion within a year.
Among the 55 studies in Macular Degeneration by National Eye Institute (NEI), from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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 reticular pseudodrusen (RPD) and abnormal dark adaptation.
Study Population: The first cohort consists of seven participants with RPD who meet the eligibility criteria. The second cohort will consist of five participants with RPD 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 two months 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 pilot, uncontrolled, prospective, single center study to investigate the potential efficacy and safety of vitamin A palmitate dosing in improving dark adaptation in participants with RPD and abnormal dark adaptation. Participants in the first cohort were instructed to take 16,000 IU of vitamin A palmitate daily for two months. Participants in the second cohort will be instructed to take 48,000 IU of vitamin A palmitate daily for one month. Enrollment for Cohort 1 ended on January 10, 2019. 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 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).
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 INCLUSION CRITERIA:
STUDY EYE EXCLUSION CRITERIA:
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:
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 reticular pseudodrusen
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
Low Luminance Questionnaire (LLQ) is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Individual questions are assigned to one of six distinct subscales and are scored in 25-point increments (range=0 to 100, higher values=better outcome). Applicable questions are averaged to produce (weighted) subscale scores (range=0 to 100, higher values=better outcome). (Weighted) Subscale scores are averaged to produce a composite score (range=0 to 100, higher values=better outcome). The mean change in LLQ composite score from baseline at the treatment completion and post-treatment completion visits are descriptively summarized. A positive score change represents improvement in functioning from baseline (i.e., higher values=better outcome), whereas a negative score change represents a decline in functioning from baseline (i.e., lower values=worse outcome).
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
Low Luminance Questionnaire (LLQ) is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Individual questions are assigned to one of six distinct subscales and are scored in 25-point increments (range=0 to 100, higher values=better outcome). Applicable questions are averaged to produce (weighted) subscale scores (range=0 to 100, higher values=better outcome). The mean change in LLQ driving subscale score from baseline at the treatment completion and post-treatment completion visits are descriptively summarized. A positive score change represents improvement in functioning from baseline (i.e., higher values=better outcome), whereas a negative score change represents a decline in functioning from baseline (i.e., lower values=worse outcome).
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
Low Luminance Questionnaire (LLQ) is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Individual questions are assigned to one of six distinct subscales and are scored in 25-point increments (range=0 to 100, higher values=better outcome). Applicable questions are averaged to produce (weighted) subscale scores (range=0 to 100, higher values=better outcome). The mean change in LLQ extreme lighting subscale score from baseline at the treatment completion and post-treatment completion visits are descriptively summarized. A positive score change represents improvement in functioning from baseline (i.e., higher values=better outcome), whereas a negative score change represents a decline in functioning from baseline (i.e., lower values=worse outcome).
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
Low Luminance Questionnaire (LLQ) is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Individual questions are assigned to one of six distinct subscales and are scored in 25-point increments (range=0 to 100, higher values=better outcome). Applicable questions are averaged to produce (weighted) subscale scores (range=0 to 100, higher values=better outcome). The mean change in LLQ mobility subscale score from baseline at the treatment completion and post-treatment completion visits are descriptively summarized. A positive score change represents improvement in functioning from baseline (i.e., higher values=better outcome), whereas a negative score change represents a decline in functioning from baseline (i.e., lower values=worse outcome).
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
Low Luminance Questionnaire (LLQ) is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Individual questions are assigned to one of six distinct subscales and are scored in 25-point increments (range=0 to 100, higher values=better outcome). Applicable questions are averaged to produce (weighted) subscale scores (range=0 to 100, higher values=better outcome). The mean change in LLQ emotional distress subscale score from baseline at the treatment completion and post-treatment completion visits are descriptively summarized. A positive score change represents improvement in functioning from baseline (i.e., higher values=better outcome), whereas a negative score change represents a decline in functioning from baseline (i.e., lower values=worse outcome).
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
Low Luminance Questionnaire (LLQ) is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Individual questions are assigned to one of six distinct subscales and are scored in 25-point increments (range=0 to 100, higher values=better outcome). Applicable questions are averaged to produce (weighted) subscale scores (range=0 to 100, higher values=better outcome). The mean change in LLQ general dim lighting subscale score from baseline at the treatment completion and post-treatment completion visits are descriptively summarized. A positive score change represents improvement in functioning from baseline (i.e., higher values=better outcome), whereas a negative score change represents a decline in functioning from baseline (i.e., lower values=worse outcome).
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
Low Luminance Questionnaire (LLQ) is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Individual questions are assigned to one of six distinct subscales and are scored in 25-point increments (range=0 to 100, higher values=better outcome). Applicable questions are averaged to produce (weighted) subscale scores (range=0 to 100, higher values=better outcome). The mean change in LLQ peripheral vision subscale score from baseline at the treatment completion and post-treatment completion visits are descriptively summarized. A positive score change represents improvement in functioning from baseline (i.e., higher values=better outcome), whereas a negative score change represents a decline in functioning from baseline (i.e., lower values=worse outcome).
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 reticular pseudodrusen (RPD) and abnormal dark adaptation may be enrolled. At the National Eye Institute, enrollment for Cohort 1 closed on January 10, 2019 and enrollment for Cohort 2 was suspended on August 31, 2023.
| Milestone | Cohort 1 | Cohort 2 |
|---|---|---|
| Started | 7 | 2 |
| Completed treatment completion visit | 7 | 2 |
| Completed | 7 | 2 |
| 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 | 16.83 ± 11.894 | 24.30 ± 16.405 |
| Treatment Completion Visit | 18.66 ± 14.622 | 26.10 ± 19.658 |
| Change from Baseline at the Treatment Completion Visit | 1.83 ± 12.193 | 1.80 ± 3.253 |
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 | 16.83 ± 11.894 | 24.30 ± 16.405 |
| Post-Treatment Follow-Up Visit | 18.70 ± 11.563 | 26.60 ± 18.809 |
| Change from Baseline at the Post-Treatment Follow-Up Visit | 1.87 ± 10.244 | 2.30 ± 2.404 |
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 | 66.0 ± 21.01 | 77.0 ± 4.24 |
| Treatment Completion Visit | 70.9 ± 10.76 | 76.5 ± 2.12 |
| Post-Treatment Follow-Up Visit | 70.0 ± 10.98 | 78.5 ± 2.12 |
| Change from Baseline at the Treatment Completion Visit | 4.9 ± 14.36 | -0.5 ± 2.12 |
| Change from Baseline at the Post-Treatment Follow-Up Visit | 4.0 ± 13.00 | 1.5 ± 2.12 |
Low Luminance Questionnaire (LLQ) is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Individual questions are assigned to one of six distinct subscales and are scored in 25-point increments (range=0 to 100, higher values=better outcome). Applicable questions are averaged to produce (weighted) subscale scores (range=0 to 100, higher values=better outcome). (Weighted) Subscale scores are averaged to produce a composite score (range=0 to 100, higher values=better outcome). The mean change in LLQ composite score from baseline at the treatment completion and post-treatment completion visits are descriptively summarized. A positive score change represents improvement in functioning from baseline (i.e., higher values=better outcome), whereas a negative score change represents a decline in functioning from baseline (i.e., lower values=worse outcome).
| score on a scale | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline Visit | 74.87 ± 20.180 | 93.54 ± 5.500 |
| Treatment Completion Visit | 74.19 ± 23.676 | 92.74 ± 5.647 |
| Post-Treatment Follow-Up Visit | 76.95 ± 16.717 | 90.64 ± 8.614 |
| Change from Baseline at the Treatment Completion Visit | -0.68 ± 7.194 | -0.80 ± 0.147 |
| Change from Baseline at the Post-Treatment Follow-Up Visit | 2.08 ± 9.926 | -2.90 ± 3.115 |
Low Luminance Questionnaire (LLQ) is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Individual questions are assigned to one of six distinct subscales and are scored in 25-point increments (range=0 to 100, higher values=better outcome). Applicable questions are averaged to produce (weighted) subscale scores (range=0 to 100, higher values=better outcome). The mean change in LLQ driving subscale score from baseline at the treatment completion and post-treatment completion visits are descriptively summarized. A positive score change represents improvement in functioning from baseline (i.e., higher values=better outcome), whereas a negative score change represents a decline in functioning from baseline (i.e., lower values=worse outcome).
| score on a scale | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline Visit | 57.86 ± 32.385 | 87.50 ± 10.607 |
| Treatment Completion Visit | 60.00 ± 37.193 | 80.0 ± 21.213 |
| Post-Treatment Follow-Up Visit | 62.14 ± 36.384 | 85.00 ± 14.142 |
| Change from Baseline at the Treatment Completion Visit | 2.14 ± 11.852 | -7.50 ± 10.607 |
| Change from Baseline at the Post-Treatment Follow-Up Visit | 4.29 ± 13.048 | -2.50 ± 3.536 |
Low Luminance Questionnaire (LLQ) is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Individual questions are assigned to one of six distinct subscales and are scored in 25-point increments (range=0 to 100, higher values=better outcome). Applicable questions are averaged to produce (weighted) subscale scores (range=0 to 100, higher values=better outcome). The mean change in LLQ extreme lighting subscale score from baseline at the treatment completion and post-treatment completion visits are descriptively summarized. A positive score change represents improvement in functioning from baseline (i.e., higher values=better outcome), whereas a negative score change represents a decline in functioning from baseline (i.e., lower values=worse outcome).
| score on a scale | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline Visit | 64.29 ± 27.884 | 86.46 ± 10.312 |
| Treatment Completion Visit | 70.54 ± 23.514 | 89.38 ± 6.187 |
| Post-Treatment Follow-Up Visit | 67.11 ± 24.003 | 86.16 ± 10.733 |
| Change from Baseline at the Treatment Completion Visit | 6.25 ± 9.200 | 2.92 ± 4.125 |
| Change from Baseline at the Post-Treatment Follow-Up Visit | 2.83 ± 14.923 | -0.30 ± 0.421 |
Low Luminance Questionnaire (LLQ) is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Individual questions are assigned to one of six distinct subscales and are scored in 25-point increments (range=0 to 100, higher values=better outcome). Applicable questions are averaged to produce (weighted) subscale scores (range=0 to 100, higher values=better outcome). The mean change in LLQ mobility subscale score from baseline at the treatment completion and post-treatment completion visits are descriptively summarized. A positive score change represents improvement in functioning from baseline (i.e., higher values=better outcome), whereas a negative score change represents a decline in functioning from baseline (i.e., lower values=worse outcome).
| score on a scale | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline Visit | 82.74 ± 16.035 | 97.50 ± 3.536 |
| Treatment Completion Visit | 83.93 ± 16.567 | 91.67 ± 5.893 |
| Post-Treatment Follow-Up Visit | 81.55 ± 13.145 | 92.50 ± 10.607 |
| Change from Baseline at the Treatment Completion Visit | 1.19 ± 8.578 | -5.83 ± 2.357 |
| Change from Baseline at the Post-Treatment Follow-Up Visit | -1.19 ± 6.682 | -5.00 ± 7.071 |
Low Luminance Questionnaire (LLQ) is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Individual questions are assigned to one of six distinct subscales and are scored in 25-point increments (range=0 to 100, higher values=better outcome). Applicable questions are averaged to produce (weighted) subscale scores (range=0 to 100, higher values=better outcome). The mean change in LLQ emotional distress subscale score from baseline at the treatment completion and post-treatment completion visits are descriptively summarized. A positive score change represents improvement in functioning from baseline (i.e., higher values=better outcome), whereas a negative score change represents a decline in functioning from baseline (i.e., lower values=worse outcome).
| score on a scale | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline Visit | 84.82 ± 13.432 | 96.88 ± 4.419 |
| Treatment Completion Visit | 79.46 ± 20.321 | 100.00 ± 0.000 |
| Post-Treatment Follow-Up Visit | 93.75 ± 9.547 | 96.88 ± 4.419 |
| Change from Baseline at the Treatment Completion Visit | -5.36 ± 12.721 | 3.13 ± 4.419 |
| Change from Baseline at the Post-Treatment Follow-Up Visit | 8.93 ± 14.369 | 0.00 ± 0.000 |
Low Luminance Questionnaire (LLQ) is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Individual questions are assigned to one of six distinct subscales and are scored in 25-point increments (range=0 to 100, higher values=better outcome). Applicable questions are averaged to produce (weighted) subscale scores (range=0 to 100, higher values=better outcome). The mean change in LLQ general dim lighting subscale score from baseline at the treatment completion and post-treatment completion visits are descriptively summarized. A positive score change represents improvement in functioning from baseline (i.e., higher values=better outcome), whereas a negative score change represents a decline in functioning from baseline (i.e., lower values=worse outcome).
| score on a scale | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline Visit | 76.19 ± 23.535 | 92.92 ± 4.125 |
| Treatment Completion Visit | 73.81 ± 25.877 | 95.42 ± 0.589 |
| Post-Treatment Follow-Up Visit | 75.00 ± 23.323 | 83.33 ± 11.785 |
| Change from Baseline at the Treatment Completion Visit | -2.38 ± 4.725 | 2.50 ± 3.536 |
| Change from Baseline at the Post-Treatment Follow-Up Visit | -1.19 ± 10.949 | -9.58 ± 7.660 |
Low Luminance Questionnaire (LLQ) is a 32-item questionnaire relating to difficulty with visual function in low luminance settings. Individual questions are assigned to one of six distinct subscales and are scored in 25-point increments (range=0 to 100, higher values=better outcome). Applicable questions are averaged to produce (weighted) subscale scores (range=0 to 100, higher values=better outcome). The mean change in LLQ peripheral vision subscale score from baseline at the treatment completion and post-treatment completion visits are descriptively summarized. A positive score change represents improvement in functioning from baseline (i.e., higher values=better outcome), whereas a negative score change represents a decline in functioning from baseline (i.e., lower values=worse outcome).
| score on a scale | Cohort 1 | Cohort 2 |
|---|---|---|
| Baseline Visit | 83.33 ± 18.002 | 100.00 ± 0.000 |
| Treatment Completion Visit | 77.38 ± 28.753 | 100.00 ± 0.000 |
| Post-Treatment Follow-Up Visit | 82.14 ± 13.113 | 100.00 ± 0.000 |
| Change from Baseline at the Treatment Completion Visit | -5.95 ± 14.203 | 0.00 ± 0.000 |
| Change from Baseline at the Post-Treatment Follow-Up Visit | -1.19 ± 15.537 | 0.00 ± 0.000 |
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 | 0/7 (0%) | 0/7 (0%) | 2/7 (28.6%) |
| Cohort 2 | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Event | Cohort 1 | Cohort 2 |
|---|---|---|
| Eye pruritusEye disorders | 1/7 | 0/2 |
| PneumoniaInfections and infestations | 1/7 | 0/2 |
| Rash papularSkin and subcutaneous tissue disorders | 1/7 | 0/2 |
| Age, Continuous(years) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Mean | 71.5 ± 9.61 | 75.0 ± 15.73 | 72.4 ± 9.58 |
| Age, Customized(Participants) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Age, Categorical — <= 18 years | 0 | 0 | 0 |
| Age, Categorical — Between 18 and 65 years | 3 | 0 | 3 |
| Age, Categorical — >= 65 years and <= 89 years | 3 | 2 | 5 |
| Age, Categorical — > 89 years | 1 | 0 | 1 |
| Sex: Female, Male(Participants) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Female | 4 | 1 | 5 |
| Male | 3 | 1 | 4 |
| Ethnicity (NIH/OMB)(Participants) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 7 | 2 | 9 |
| 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 | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 6 | 2 | 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 | 7 | 2 | 9 |
| Dark Adaptation Rod Intercept Time(minutes) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Mean | 16.83 ± 11.894 | 24.30 ± 16.405 | 18.49 ± 12.272 |
| Low Luminance Visual Acuity (LLVA) Total Letters Read(letters read) | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Mean | 66.0 ± 21.01 | 77.0 ± 4.24 | 68.4 ± 18.89 |
7 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from May 2018 to primary completion in Jun 2022, 49 months.
Results were first posted in Jul 2024, 2 years after primary completion.
Of 75 phase 1 interventional studies under Macular Degeneration, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 30. This study's 49 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Retinol palmitate
National Eye Institute (NEI) →