Trial Outcomes & Findings for Vitamin A Palmitate Supplementation in People With Age-Related Macular Degeneration (and Without Reticular Pseudodrusen) and Delayed Dark Adaptation (NCT NCT03478865)
NCT ID: NCT03478865
Last Updated: 2025-04-15
Results Overview
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%.
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
8 participants
Primary outcome timeframe
Baseline to Month 2 for Cohort 1 and Baseline to Month 1 for Cohort 2
Results posted on
2025-04-15
Participant Flow
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.
Participants met all inclusion criteria and none of the exclusion criteria for at least on eye as defined in the protocol. If both eyes met the eligibility criteria, the eye with the better visual acuity was chosen as the study eye. Participants enrolled after May 24, 2019 were enrolled into Cohort 2. All eligible participants underwent treatment starting at Baseline. The IP used in the study was vitamin A palmitate and was not anticipated to differentially treat participant eyes.
Participant milestones
| Measure |
Cohort 1
Oral administration of vitamin A palmitate. Vitamin A palmitate: Participants in Cohort 1 were instructed to take 16,000 international unit of investigational product (IP) daily for two months. At Baseline and Month 1, a one month supply of IP was dispensed to the participant during the study visit. Participants were required to bring their bottles of IP to each appropriate visit for IP counts for compliance monitoring. Participants could complete participation in the study one month after IP supplementation (Month 3). At the conclusion of the study, participants were no longer eligible to receive IP under this protocol.
|
Cohort 2
Oral administration of vitamin A palmitate. Vitamin A palmitate: Participants in Cohort 2 were instructed to take 48,000 international unit of investigational product (IP) daily for one month. Participants in Cohort 1 could 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. At Baseline, a one month supply of IP was dispensed to the participant during the study visit. Participants were required to bring their bottles of IP to each appropriate visit for IP counts for compliance monitoring. Participants could complete participation in the study one month after IP supplementation (Month 2). At the conclusion of the study, participants were no longer eligible to receive IP under this protocol.
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|---|---|---|
|
Overall Study
STARTED
|
5
|
3
|
|
Overall Study
Completed Treatment Completion Visit
|
5
|
3
|
|
Overall Study
COMPLETED
|
5
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vitamin A Palmitate Supplementation in People With Age-Related Macular Degeneration (and Without Reticular Pseudodrusen) and Delayed Dark Adaptation
Baseline characteristics by cohort
| Measure |
Cohort 1
n=5 Participants
Oral administration of vitamin A palmitate. Vitamin A palmitate: Participants in Cohort 1 were instructed to take 16,000 international unit of investigational product (IP) daily for two months. At Baseline and Month 1, a one month supply of IP was dispensed to the participant during the study visit. Participants were required to bring their bottles of IP to each appropriate visit for IP counts for compliance monitoring. Participants could complete participation in the study one month after IP supplementation (Month 3). At the conclusion of the study, participants were no longer eligible to receive IP under this protocol.
|
Cohort 2
n=3 Participants
Oral administration of vitamin A palmitate. Vitamin A palmitate: Participants in Cohort 2 were instructed to take 48,000 international unit of investigational product (IP) daily for one month. 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. At Baseline, a one month supply of IP was dispensed to the participant during the study visit. Participants were required to bring their bottles of IP to each appropriate visit for IP counts for compliance monitoring. Participants could complete participation in the study one month after IP supplementation (Month 2). At the conclusion of the study, participants were no longer eligible to receive IP under this protocol.
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Total
n=8 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
78.0 years
STANDARD_DEVIATION 4.74 • n=5 Participants
|
80.0 years
STANDARD_DEVIATION 7.00 • n=7 Participants
|
78.8 years
STANDARD_DEVIATION 5.28 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Dark Adaptation Rod Intercept Time
|
25.12 minutes
STANDARD_DEVIATION 10.755 • n=5 Participants
|
20.03 minutes
STANDARD_DEVIATION 6.793 • n=7 Participants
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23.21 minutes
STANDARD_DEVIATION 9.285 • n=5 Participants
|
|
Low Luminance Visual Acuity (LLVA) Total Letters Read
|
66.8 letters read
STANDARD_DEVIATION 16.22 • n=5 Participants
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56.3 letters read
STANDARD_DEVIATION 16.17 • n=7 Participants
|
62.9 letters read
STANDARD_DEVIATION 15.95 • n=5 Participants
|
|
Low Luminance Questionnaire (LLQ) Composite Score
|
86.35 score on a scale
STANDARD_DEVIATION 17.521 • n=5 Participants
|
86.79 score on a scale
STANDARD_DEVIATION 11.431 • n=7 Participants
|
86.51 score on a scale
STANDARD_DEVIATION 14.588 • n=5 Participants
|
|
Low Luminance Questionnaire (LLQ) Driving Subscale Score
|
86.00 score on a scale
STANDARD_DEVIATION 20.433 • n=5 Participants
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68.33 score on a scale
STANDARD_DEVIATION 37.859 • n=7 Participants
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79.38 score on a scale
STANDARD_DEVIATION 27.050 • n=5 Participants
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Low Luminance Questionnaire (LLQ) Extreme Lighting Subscale Score
|
81.25 score on a scale
STANDARD_DEVIATION 18.880 • n=5 Participants
|
73.96 score on a scale
STANDARD_DEVIATION 26.578 • n=7 Participants
|
78.52 score on a scale
STANDARD_DEVIATION 20.488 • n=5 Participants
|
|
Low Luminance Questionnaire (LLQ) Mobility Subscale Score
|
88.33 score on a scale
STANDARD_DEVIATION 16.245 • n=5 Participants
|
96.53 score on a scale
STANDARD_DEVIATION 3.182 • n=7 Participants
|
91.41 score on a scale
STANDARD_DEVIATION 13.102 • n=5 Participants
|
|
Low Luminance Questionnaire (LLQ) Emotional Distress Subscale Score
|
95.00 score on a scale
STANDARD_DEVIATION 8.149 • n=5 Participants
|
97.22 score on a scale
STANDARD_DEVIATION 4.811 • n=7 Participants
|
95.83 score on a scale
STANDARD_DEVIATION 6.774 • n=5 Participants
|
|
Low Luminance Questionnaire (LLQ) General Dim Lighting Subscale Score
|
82.50 score on a scale
STANDARD_DEVIATION 26.087 • n=5 Participants
|
90.28 score on a scale
STANDARD_DEVIATION 2.406 • n=7 Participants
|
85.42 score on a scale
STANDARD_DEVIATION 20.168 • n=5 Participants
|
|
Low Luminance Questionnaire (LLQ) Peripheral Vision Subscale Score
|
85.00 score on a scale
STANDARD_DEVIATION 22.361 • n=5 Participants
|
94.44 score on a scale
STANDARD_DEVIATION 9.623 • n=7 Participants
|
88.54 score on a scale
STANDARD_DEVIATION 18.332 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Month 2 for Cohort 1 and Baseline to Month 1 for Cohort 2Population: Primary Analysis Population: Participants enrolled who received IP through the treatment completion visit.
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%.
Outcome measures
| Measure |
Cohort 1
n=5 Participants
Oral administration of vitamin A palmitate. Vitamin A palmitate: Participants in Cohort 1 were instructed to take 16,000 international unit of investigational product (IP) daily for two months. At Baseline and Month 1, a one month supply of IP was dispensed to the participant during the study visit. Participants were required to bring their bottles of IP to each appropriate visit for IP counts for compliance monitoring. Participants could complete participation in the study one month after IP supplementation (Month 3). At the conclusion of the study, participants were no longer eligible to receive IP under this protocol.
|
Cohort 2
n=3 Participants
Oral administration of vitamin A palmitate. Vitamin A palmitate: Participants in Cohort 2 were instructed to take 48,000 international unit of investigational product (IP) daily for one month. 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. At Baseline, a one month supply of IP was dispensed to the participant during the study visit. Participants were required to bring their bottles of IP to each appropriate visit for IP counts for compliance monitoring. Participants could complete participation in the study one month after IP supplementation (Month 2). At the conclusion of the study, participants were no longer eligible to receive IP under this protocol.
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|---|---|---|
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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)
Baseline Visit
|
25.12 Minutes
Standard Deviation 10.755
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20.03 Minutes
Standard Deviation 6.793
|
|
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)
Treatment Completion Visit
|
22.58 Minutes
Standard Deviation 8.219
|
19.77 Minutes
Standard Deviation 7.753
|
|
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)
Change from Baseline at the Treatment Completion Visit
|
-2.54 Minutes
Standard Deviation 4.322
|
-0.27 Minutes
Standard Deviation 1.767
|
SECONDARY outcome
Timeframe: Baseline to Month 3 for Cohort 1 and Baseline to Month 2 for Cohort 2Population: Primary Analysis Population: Participants enrolled who received IP through the treatment completion visit.
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%.
Outcome measures
| Measure |
Cohort 1
n=5 Participants
Oral administration of vitamin A palmitate. Vitamin A palmitate: Participants in Cohort 1 were instructed to take 16,000 international unit of investigational product (IP) daily for two months. At Baseline and Month 1, a one month supply of IP was dispensed to the participant during the study visit. Participants were required to bring their bottles of IP to each appropriate visit for IP counts for compliance monitoring. Participants could complete participation in the study one month after IP supplementation (Month 3). At the conclusion of the study, participants were no longer eligible to receive IP under this protocol.
|
Cohort 2
n=3 Participants
Oral administration of vitamin A palmitate. Vitamin A palmitate: Participants in Cohort 2 were instructed to take 48,000 international unit of investigational product (IP) daily for one month. 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. At Baseline, a one month supply of IP was dispensed to the participant during the study visit. Participants were required to bring their bottles of IP to each appropriate visit for IP counts for compliance monitoring. Participants could complete participation in the study one month after IP supplementation (Month 2). At the conclusion of the study, participants were no longer eligible to receive IP under this protocol.
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|---|---|---|
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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).
Baseline Visit
|
25.12 minutes
Standard Deviation 10.755
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20.03 minutes
Standard Deviation 6.793
|
|
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).
Post-Treatment Follow-Up Visit
|
21.56 minutes
Standard Deviation 6.271
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23.27 minutes
Standard Deviation 12.847
|
|
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).
Change from Baseline at the Post-Treatment Follow-Up Visit
|
-3.56 minutes
Standard Deviation 7.793
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3.23 minutes
Standard Deviation 6.512
|
SECONDARY outcome
Timeframe: 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 2Population: Primary Analysis Population: Participants enrolled who received IP through the treatment completion visit.
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.
Outcome measures
| Measure |
Cohort 1
n=5 Participants
Oral administration of vitamin A palmitate. Vitamin A palmitate: Participants in Cohort 1 were instructed to take 16,000 international unit of investigational product (IP) daily for two months. At Baseline and Month 1, a one month supply of IP was dispensed to the participant during the study visit. Participants were required to bring their bottles of IP to each appropriate visit for IP counts for compliance monitoring. Participants could complete participation in the study one month after IP supplementation (Month 3). At the conclusion of the study, participants were no longer eligible to receive IP under this protocol.
|
Cohort 2
n=3 Participants
Oral administration of vitamin A palmitate. Vitamin A palmitate: Participants in Cohort 2 were instructed to take 48,000 international unit of investigational product (IP) daily for one month. 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. At Baseline, a one month supply of IP was dispensed to the participant during the study visit. Participants were required to bring their bottles of IP to each appropriate visit for IP counts for compliance monitoring. Participants could complete participation in the study one month after IP supplementation (Month 2). At the conclusion of the study, participants were no longer eligible to receive IP under this protocol.
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|---|---|---|
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Change in Low Luminance Visual Acuity (LLVA) From Baseline in the Study Eye at the Treatment Completion and Post-Treatment Follow-Up Visits
Change from Baseline at the Post-Treatment Follow-Up Visit
|
3.0 letters read
Standard Deviation 14.88
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3.0 letters read
Standard Deviation 2.00
|
|
Change in Low Luminance Visual Acuity (LLVA) From Baseline in the Study Eye at the Treatment Completion and Post-Treatment Follow-Up Visits
Baseline Visit
|
66.8 letters read
Standard Deviation 16.22
|
56.3 letters read
Standard Deviation 16.17
|
|
Change in Low Luminance Visual Acuity (LLVA) From Baseline in the Study Eye at the Treatment Completion and Post-Treatment Follow-Up Visits
Treatment Completion Visit
|
71.6 letters read
Standard Deviation 11.41
|
59.3 letters read
Standard Deviation 16.01
|
|
Change in Low Luminance Visual Acuity (LLVA) From Baseline in the Study Eye at the Treatment Completion and Post-Treatment Follow-Up Visits
Change from Baseline at the Treatment Completion Visit
|
4.8 letters read
Standard Deviation 17.31
|
3.0 letters read
Standard Deviation 1.73
|
|
Change in Low Luminance Visual Acuity (LLVA) From Baseline in the Study Eye at the Treatment Completion and Post-Treatment Follow-Up Visits
Post-Treatment Follow-Up Visit
|
69.8 letters read
Standard Deviation 6.69
|
59.3 letters read
Standard Deviation 17.01
|
SECONDARY outcome
Timeframe: 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 2Population: Primary Analysis Population: Participants enrolled who received IP through the treatment completion visit.
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.
Outcome measures
| Measure |
Cohort 1
n=5 Participants
Oral administration of vitamin A palmitate. Vitamin A palmitate: Participants in Cohort 1 were instructed to take 16,000 international unit of investigational product (IP) daily for two months. At Baseline and Month 1, a one month supply of IP was dispensed to the participant during the study visit. Participants were required to bring their bottles of IP to each appropriate visit for IP counts for compliance monitoring. Participants could complete participation in the study one month after IP supplementation (Month 3). At the conclusion of the study, participants were no longer eligible to receive IP under this protocol.
|
Cohort 2
n=3 Participants
Oral administration of vitamin A palmitate. Vitamin A palmitate: Participants in Cohort 2 were instructed to take 48,000 international unit of investigational product (IP) daily for one month. 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. At Baseline, a one month supply of IP was dispensed to the participant during the study visit. Participants were required to bring their bottles of IP to each appropriate visit for IP counts for compliance monitoring. Participants could complete participation in the study one month after IP supplementation (Month 2). At the conclusion of the study, participants were no longer eligible to receive IP under this protocol.
|
|---|---|---|
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Change in Low Luminance Questionnaire (LLQ) Composite Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Baseline Visit
|
86.35 score on a scale
Standard Deviation 17.521
|
86.79 score on a scale
Standard Deviation 11.431
|
|
Change in Low Luminance Questionnaire (LLQ) Composite Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Treatment Completion Visit
|
87.38 score on a scale
Standard Deviation 17.420
|
86.13 score on a scale
Standard Deviation 9.958
|
|
Change in Low Luminance Questionnaire (LLQ) Composite Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Post-Treatment Follow-Up Visit
|
84.83 score on a scale
Standard Deviation 19.142
|
88.73 score on a scale
Standard Deviation 7.382
|
|
Change in Low Luminance Questionnaire (LLQ) Composite Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Change from Baseline at the Treatment Completion Visit
|
1.03 score on a scale
Standard Deviation 1.087
|
-0.66 score on a scale
Standard Deviation 2.815
|
|
Change in Low Luminance Questionnaire (LLQ) Composite Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Change from Baseline at the Post-Treatment Follow-Up Visit
|
-1.51 score on a scale
Standard Deviation 3.283
|
1.93 score on a scale
Standard Deviation 5.435
|
SECONDARY outcome
Timeframe: 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 2Population: Primary Analysis Population: Participants enrolled who received IP through the treatment completion visit.
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.
Outcome measures
| Measure |
Cohort 1
n=5 Participants
Oral administration of vitamin A palmitate. Vitamin A palmitate: Participants in Cohort 1 were instructed to take 16,000 international unit of investigational product (IP) daily for two months. At Baseline and Month 1, a one month supply of IP was dispensed to the participant during the study visit. Participants were required to bring their bottles of IP to each appropriate visit for IP counts for compliance monitoring. Participants could complete participation in the study one month after IP supplementation (Month 3). At the conclusion of the study, participants were no longer eligible to receive IP under this protocol.
|
Cohort 2
n=3 Participants
Oral administration of vitamin A palmitate. Vitamin A palmitate: Participants in Cohort 2 were instructed to take 48,000 international unit of investigational product (IP) daily for one month. 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. At Baseline, a one month supply of IP was dispensed to the participant during the study visit. Participants were required to bring their bottles of IP to each appropriate visit for IP counts for compliance monitoring. Participants could complete participation in the study one month after IP supplementation (Month 2). At the conclusion of the study, participants were no longer eligible to receive IP under this protocol.
|
|---|---|---|
|
Change in Low Luminance Questionnaire (LLQ) Driving Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Baseline Visit
|
86.00 score on a scale
Standard Deviation 20.433
|
68.33 score on a scale
Standard Deviation 37.859
|
|
Change in Low Luminance Questionnaire (LLQ) Driving Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Treatment Completion Visit
|
87.00 score on a scale
Standard Deviation 17.889
|
55.00 score on a scale
Standard Deviation 36.056
|
|
Change in Low Luminance Questionnaire (LLQ) Driving Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Post-Treatment Follow-Up Visit
|
84.00 score on a scale
Standard Deviation 22.192
|
63.33 score on a scale
Standard Deviation 33.292
|
|
Change in Low Luminance Questionnaire (LLQ) Driving Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Change from Baseline at the Treatment Completion Visit
|
1.00 score on a scale
Standard Deviation 8.944
|
-13.33 score on a scale
Standard Deviation 5.774
|
|
Change in Low Luminance Questionnaire (LLQ) Driving Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Change from Baseline at the Post-Treatment Follow-Up Visit
|
-2.00 score on a scale
Standard Deviation 4.472
|
-5.00 score on a scale
Standard Deviation 5.000
|
SECONDARY outcome
Timeframe: 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 2Population: Primary Analysis Population: Participants enrolled who received IP through the treatment completion visit.
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.
Outcome measures
| Measure |
Cohort 1
n=5 Participants
Oral administration of vitamin A palmitate. Vitamin A palmitate: Participants in Cohort 1 were instructed to take 16,000 international unit of investigational product (IP) daily for two months. At Baseline and Month 1, a one month supply of IP was dispensed to the participant during the study visit. Participants were required to bring their bottles of IP to each appropriate visit for IP counts for compliance monitoring. Participants could complete participation in the study one month after IP supplementation (Month 3). At the conclusion of the study, participants were no longer eligible to receive IP under this protocol.
|
Cohort 2
n=3 Participants
Oral administration of vitamin A palmitate. Vitamin A palmitate: Participants in Cohort 2 were instructed to take 48,000 international unit of investigational product (IP) daily for one month. 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. At Baseline, a one month supply of IP was dispensed to the participant during the study visit. Participants were required to bring their bottles of IP to each appropriate visit for IP counts for compliance monitoring. Participants could complete participation in the study one month after IP supplementation (Month 2). At the conclusion of the study, participants were no longer eligible to receive IP under this protocol.
|
|---|---|---|
|
Change in Low Luminance Questionnaire (LLQ) Extreme Lighting Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Baseline Visit
|
81.25 score on a scale
Standard Deviation 18.880
|
73.96 score on a scale
Standard Deviation 26.578
|
|
Change in Low Luminance Questionnaire (LLQ) Extreme Lighting Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Treatment Completion Visit
|
84.38 score on a scale
Standard Deviation 20.492
|
77.08 score on a scale
Standard Deviation 25.259
|
|
Change in Low Luminance Questionnaire (LLQ) Extreme Lighting Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Post-Treatment Follow-Up Visit
|
78.75 score on a scale
Standard Deviation 20.420
|
80.83 score on a scale
Standard Deviation 12.521
|
|
Change in Low Luminance Questionnaire (LLQ) Extreme Lighting Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Change from Baseline at the Treatment Completion Visit
|
3.13 score on a scale
Standard Deviation 5.846
|
3.13 score on a scale
Standard Deviation 5.413
|
|
Change in Low Luminance Questionnaire (LLQ) Extreme Lighting Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Change from Baseline at the Post-Treatment Follow-Up Visit
|
-2.50 score on a scale
Standard Deviation 6.775
|
6.88 score on a scale
Standard Deviation 26.612
|
SECONDARY outcome
Timeframe: 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 2Population: Primary Analysis Population: Participants enrolled who received IP through the treatment completion visit.
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.
Outcome measures
| Measure |
Cohort 1
n=5 Participants
Oral administration of vitamin A palmitate. Vitamin A palmitate: Participants in Cohort 1 were instructed to take 16,000 international unit of investigational product (IP) daily for two months. At Baseline and Month 1, a one month supply of IP was dispensed to the participant during the study visit. Participants were required to bring their bottles of IP to each appropriate visit for IP counts for compliance monitoring. Participants could complete participation in the study one month after IP supplementation (Month 3). At the conclusion of the study, participants were no longer eligible to receive IP under this protocol.
|
Cohort 2
n=3 Participants
Oral administration of vitamin A palmitate. Vitamin A palmitate: Participants in Cohort 2 were instructed to take 48,000 international unit of investigational product (IP) daily for one month. 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. At Baseline, a one month supply of IP was dispensed to the participant during the study visit. Participants were required to bring their bottles of IP to each appropriate visit for IP counts for compliance monitoring. Participants could complete participation in the study one month after IP supplementation (Month 2). At the conclusion of the study, participants were no longer eligible to receive IP under this protocol.
|
|---|---|---|
|
Change in Low Luminance Questionnaire (LLQ) Mobility Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Baseline Visit
|
88.33 score on a scale
Standard Deviation 16.245
|
96.53 score on a scale
Standard Deviation 3.182
|
|
Change in Low Luminance Questionnaire (LLQ) Mobility Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Treatment Completion Visit
|
90.00 score on a scale
Standard Deviation 14.006
|
97.22 score on a scale
Standard Deviation 2.406
|
|
Change in Low Luminance Questionnaire (LLQ) Mobility Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Post-Treatment Follow-Up Visit
|
88.33 score on a scale
Standard Deviation 15.975
|
97.22 score on a scale
Standard Deviation 2.406
|
|
Change in Low Luminance Questionnaire (LLQ) Mobility Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Change from Baseline at the Treatment Completion Visit
|
1.67 score on a scale
Standard Deviation 2.282
|
0.69 score on a scale
Standard Deviation 5.243
|
|
Change in Low Luminance Questionnaire (LLQ) Mobility Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Change from Baseline at the Post-Treatment Follow-Up Visit
|
0.00 score on a scale
Standard Deviation 2.946
|
0.69 score on a scale
Standard Deviation 5.243
|
SECONDARY outcome
Timeframe: 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 2Population: Primary Analysis Population: Participants enrolled who received IP through the treatment completion visit.
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.
Outcome measures
| Measure |
Cohort 1
n=5 Participants
Oral administration of vitamin A palmitate. Vitamin A palmitate: Participants in Cohort 1 were instructed to take 16,000 international unit of investigational product (IP) daily for two months. At Baseline and Month 1, a one month supply of IP was dispensed to the participant during the study visit. Participants were required to bring their bottles of IP to each appropriate visit for IP counts for compliance monitoring. Participants could complete participation in the study one month after IP supplementation (Month 3). At the conclusion of the study, participants were no longer eligible to receive IP under this protocol.
|
Cohort 2
n=3 Participants
Oral administration of vitamin A palmitate. Vitamin A palmitate: Participants in Cohort 2 were instructed to take 48,000 international unit of investigational product (IP) daily for one month. 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. At Baseline, a one month supply of IP was dispensed to the participant during the study visit. Participants were required to bring their bottles of IP to each appropriate visit for IP counts for compliance monitoring. Participants could complete participation in the study one month after IP supplementation (Month 2). At the conclusion of the study, participants were no longer eligible to receive IP under this protocol.
|
|---|---|---|
|
Change in Low Luminance Questionnaire (LLQ) Emotional Distress Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Baseline Visit
|
95.00 score on a scale
Standard Deviation 8.149
|
97.22 score on a scale
Standard Deviation 4.811
|
|
Change in Low Luminance Questionnaire (LLQ) Emotional Distress Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Treatment Completion Visit
|
93.75 score on a scale
Standard Deviation 10.825
|
95.14 score on a scale
Standard Deviation 4.337
|
|
Change in Low Luminance Questionnaire (LLQ) Emotional Distress Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Post-Treatment Follow-Up Visit
|
93.75 score on a scale
Standard Deviation 10.825
|
97.92 score on a scale
Standard Deviation 3.608
|
|
Change in Low Luminance Questionnaire (LLQ) Emotional Distress Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Change from Baseline at the Treatment Completion Visit
|
-1.25 score on a scale
Standard Deviation 2.795
|
-2.08 score on a scale
Standard Deviation 3.608
|
|
Change in Low Luminance Questionnaire (LLQ) Emotional Distress Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Change from Baseline at the Post-Treatment Follow-Up Visit
|
-1.25 score on a scale
Standard Deviation 2.795
|
0.69 score on a scale
Standard Deviation 1.203
|
SECONDARY outcome
Timeframe: 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 2Population: Primary Analysis Population: Participants enrolled who received IP through the treatment completion visit.
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.
Outcome measures
| Measure |
Cohort 1
n=5 Participants
Oral administration of vitamin A palmitate. Vitamin A palmitate: Participants in Cohort 1 were instructed to take 16,000 international unit of investigational product (IP) daily for two months. At Baseline and Month 1, a one month supply of IP was dispensed to the participant during the study visit. Participants were required to bring their bottles of IP to each appropriate visit for IP counts for compliance monitoring. Participants could complete participation in the study one month after IP supplementation (Month 3). At the conclusion of the study, participants were no longer eligible to receive IP under this protocol.
|
Cohort 2
n=3 Participants
Oral administration of vitamin A palmitate. Vitamin A palmitate: Participants in Cohort 2 were instructed to take 48,000 international unit of investigational product (IP) daily for one month. 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. At Baseline, a one month supply of IP was dispensed to the participant during the study visit. Participants were required to bring their bottles of IP to each appropriate visit for IP counts for compliance monitoring. Participants could complete participation in the study one month after IP supplementation (Month 2). At the conclusion of the study, participants were no longer eligible to receive IP under this protocol.
|
|---|---|---|
|
Change in Low Luminance Questionnaire (LLQ) General Dim Lighting Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Baseline Visit
|
82.50 score on a scale
Standard Deviation 26.087
|
90.28 score on a scale
Standard Deviation 2.406
|
|
Change in Low Luminance Questionnaire (LLQ) General Dim Lighting Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Treatment Completion Visit
|
84.17 score on a scale
Standard Deviation 24.008
|
95.14 score on a scale
Standard Deviation 4.337
|
|
Change in Low Luminance Questionnaire (LLQ) General Dim Lighting Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Post-Treatment Follow-Up Visit
|
82.50 score on a scale
Standard Deviation 25.069
|
93.06 score on a scale
Standard Deviation 6.365
|
|
Change in Low Luminance Questionnaire (LLQ) General Dim Lighting Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Change from Baseline at the Treatment Completion Visit
|
1.67 score on a scale
Standard Deviation 2.282
|
4.86 score on a scale
Standard Deviation 4.337
|
|
Change in Low Luminance Questionnaire (LLQ) General Dim Lighting Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Change from Baseline at the Post-Treatment Follow-Up Visit
|
0.00 score on a scale
Standard Deviation 2.946
|
2.78 score on a scale
Standard Deviation 4.811
|
SECONDARY outcome
Timeframe: 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 2Population: Primary Analysis Population: Participants enrolled who received IP through the treatment completion visit.
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.
Outcome measures
| Measure |
Cohort 1
n=5 Participants
Oral administration of vitamin A palmitate. Vitamin A palmitate: Participants in Cohort 1 were instructed to take 16,000 international unit of investigational product (IP) daily for two months. At Baseline and Month 1, a one month supply of IP was dispensed to the participant during the study visit. Participants were required to bring their bottles of IP to each appropriate visit for IP counts for compliance monitoring. Participants could complete participation in the study one month after IP supplementation (Month 3). At the conclusion of the study, participants were no longer eligible to receive IP under this protocol.
|
Cohort 2
n=3 Participants
Oral administration of vitamin A palmitate. Vitamin A palmitate: Participants in Cohort 2 were instructed to take 48,000 international unit of investigational product (IP) daily for one month. 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. At Baseline, a one month supply of IP was dispensed to the participant during the study visit. Participants were required to bring their bottles of IP to each appropriate visit for IP counts for compliance monitoring. Participants could complete participation in the study one month after IP supplementation (Month 2). At the conclusion of the study, participants were no longer eligible to receive IP under this protocol.
|
|---|---|---|
|
Change in Low Luminance Questionnaire (LLQ) Peripheral Vision Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Baseline Visit
|
85.00 score on a scale
Standard Deviation 22.361
|
94.44 score on a scale
Standard Deviation 9.623
|
|
Change in Low Luminance Questionnaire (LLQ) Peripheral Vision Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Treatment Completion Visit
|
85.00 score on a scale
Standard Deviation 22.361
|
97.22 score on a scale
Standard Deviation 4.811
|
|
Change in Low Luminance Questionnaire (LLQ) Peripheral Vision Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Post-Treatment Follow-Up Visit
|
81.67 score on a scale
Standard Deviation 25.276
|
100.00 score on a scale
Standard Deviation 0.000
|
|
Change in Low Luminance Questionnaire (LLQ) Peripheral Vision Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Change from Baseline at the Treatment Completion Visit
|
0.00 score on a scale
Standard Deviation 0.000
|
2.78 score on a scale
Standard Deviation 4.811
|
|
Change in Low Luminance Questionnaire (LLQ) Peripheral Vision Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up Visits
Change from Baseline at the Post-Treatment Follow-Up Visit
|
-3.33 score on a scale
Standard Deviation 7.454
|
5.56 score on a scale
Standard Deviation 9.623
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1
n=5 participants at risk
Oral administration of vitamin A palmitate. Vitamin A palmitate: Participants in Cohort 1 were instructed to take 16,000 international unit of investigational product (IP) daily for two months. At Baseline and Month 1, a one month supply of IP was dispensed to the participant during the study visit. Participants were required to bring their bottles of IP to each appropriate visit for IP counts for compliance monitoring. Participants could complete participation in the study one month after IP supplementation (Month 3). At the conclusion of the study, participants were no longer eligible to receive IP under this protocol.
|
Cohort 2
n=3 participants at risk
Oral administration of vitamin A palmitate. Vitamin A palmitate: Participants in Cohort 2 were instructed to take 48,000 international unit of investigational product (IP) daily for one month. 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. At Baseline, a one month supply of IP was dispensed to the participant during the study visit. Participants were required to bring their bottles of IP to each appropriate visit for IP counts for compliance monitoring. Participants could complete participation in the study one month after IP supplementation (Month 2). At the conclusion of the study, participants were no longer eligible to receive IP under this protocol.
|
|---|---|---|
|
Eye disorders
Cataract
|
0.00%
0/5 • Participants enrolled are assessed for AEs starting at Baseline through study completion (Month 3 for Cohort 1 and Month 2 for Cohort 2).
|
33.3%
1/3 • Number of events 1 • Participants enrolled are assessed for AEs starting at Baseline through study completion (Month 3 for Cohort 1 and Month 2 for Cohort 2).
|
|
Eye disorders
Eye irritation
|
20.0%
1/5 • Number of events 1 • Participants enrolled are assessed for AEs starting at Baseline through study completion (Month 3 for Cohort 1 and Month 2 for Cohort 2).
|
0.00%
0/3 • Participants enrolled are assessed for AEs starting at Baseline through study completion (Month 3 for Cohort 1 and Month 2 for Cohort 2).
|
|
Eye disorders
Lacrimal disorder
|
20.0%
1/5 • Number of events 1 • Participants enrolled are assessed for AEs starting at Baseline through study completion (Month 3 for Cohort 1 and Month 2 for Cohort 2).
|
0.00%
0/3 • Participants enrolled are assessed for AEs starting at Baseline through study completion (Month 3 for Cohort 1 and Month 2 for Cohort 2).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/5 • Participants enrolled are assessed for AEs starting at Baseline through study completion (Month 3 for Cohort 1 and Month 2 for Cohort 2).
|
33.3%
1/3 • Number of events 1 • Participants enrolled are assessed for AEs starting at Baseline through study completion (Month 3 for Cohort 1 and Month 2 for Cohort 2).
|
|
General disorders
Swelling
|
0.00%
0/5 • Participants enrolled are assessed for AEs starting at Baseline through study completion (Month 3 for Cohort 1 and Month 2 for Cohort 2).
|
33.3%
1/3 • Number of events 1 • Participants enrolled are assessed for AEs starting at Baseline through study completion (Month 3 for Cohort 1 and Month 2 for Cohort 2).
|
|
Investigations
Blood pressure increased
|
20.0%
1/5 • Number of events 1 • Participants enrolled are assessed for AEs starting at Baseline through study completion (Month 3 for Cohort 1 and Month 2 for Cohort 2).
|
0.00%
0/3 • Participants enrolled are assessed for AEs starting at Baseline through study completion (Month 3 for Cohort 1 and Month 2 for Cohort 2).
|
|
Investigations
Blood uric acid increased
|
0.00%
0/5 • Participants enrolled are assessed for AEs starting at Baseline through study completion (Month 3 for Cohort 1 and Month 2 for Cohort 2).
|
33.3%
1/3 • Number of events 1 • Participants enrolled are assessed for AEs starting at Baseline through study completion (Month 3 for Cohort 1 and Month 2 for Cohort 2).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/5 • Participants enrolled are assessed for AEs starting at Baseline through study completion (Month 3 for Cohort 1 and Month 2 for Cohort 2).
|
33.3%
1/3 • Number of events 1 • Participants enrolled are assessed for AEs starting at Baseline through study completion (Month 3 for Cohort 1 and Month 2 for Cohort 2).
|
|
Reproductive system and breast disorders
Prostatic mass
|
0.00%
0/5 • Participants enrolled are assessed for AEs starting at Baseline through study completion (Month 3 for Cohort 1 and Month 2 for Cohort 2).
|
33.3%
1/3 • Number of events 1 • Participants enrolled are assessed for AEs starting at Baseline through study completion (Month 3 for Cohort 1 and Month 2 for Cohort 2).
|
|
Eye disorders
Visual Impairment
|
20.0%
1/5 • Number of events 1 • Participants enrolled are assessed for AEs starting at Baseline through study completion (Month 3 for Cohort 1 and Month 2 for Cohort 2).
|
0.00%
0/3 • Participants enrolled are assessed for AEs starting at Baseline through study completion (Month 3 for Cohort 1 and Month 2 for Cohort 2).
|
Additional Information
Emily Chew, MD, Principal Investigator, NEI
National Institutes of Health
Phone: 3014966583
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place