50 and older, any sex, with AMD. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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)Primary· Baseline to Month 2 for Cohort 1 and Baseline to 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%.
Baseline Visit
Group
Value
95% CI
Cohort 1
25.12
± 10.755
Cohort 2
20.03
± 6.793
Treatment Completion Visit
Group
Value
95% CI
Cohort 1
22.58
± 8.219
Cohort 2
19.77
± 7.753
Change from Baseline at the Treatment Completion Visit
Group
Value
95% CI
Cohort 1
-2.54
± 4.322
Cohort 2
-0.27
± 1.767
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).Secondary· Baseline to Month 3 for Cohort 1 and Baseline to 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%.
Baseline Visit
Group
Value
95% CI
Cohort 1
25.12
± 10.755
Cohort 2
20.03
± 6.793
Post-Treatment Follow-Up Visit
Group
Value
95% CI
Cohort 1
21.56
± 6.271
Cohort 2
23.27
± 12.847
Change from Baseline at the Post-Treatment Follow-Up Visit
Group
Value
95% CI
Cohort 1
-3.56
± 7.793
Cohort 2
3.23
± 6.512
Change in Low Luminance Visual Acuity (LLVA) From Baseline in the Study Eye at the Treatment Completion and Post-Treatment Follow-Up VisitsSecondary· 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
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.
Baseline Visit
Group
Value
95% CI
Cohort 1
66.8
± 16.22
Cohort 2
56.3
± 16.17
Treatment Completion Visit
Group
Value
95% CI
Cohort 1
71.6
± 11.41
Cohort 2
59.3
± 16.01
Change from Baseline at the Treatment Completion Visit
Group
Value
95% CI
Cohort 1
4.8
± 17.31
Cohort 2
3.0
± 1.73
Post-Treatment Follow-Up Visit
Group
Value
95% CI
Cohort 1
69.8
± 6.69
Cohort 2
59.3
± 17.01
Change from Baseline at the Post-Treatment Follow-Up Visit
Group
Value
95% CI
Cohort 1
3.0
± 14.88
Cohort 2
3.0
± 2.00
Change in Low Luminance Questionnaire (LLQ) Composite Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up VisitsSecondary· 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
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; (we
Baseline Visit
Group
Value
95% CI
Cohort 1
86.35
± 17.521
Cohort 2
86.79
± 11.431
Treatment Completion Visit
Group
Value
95% CI
Cohort 1
87.38
± 17.420
Cohort 2
86.13
± 9.958
Post-Treatment Follow-Up Visit
Group
Value
95% CI
Cohort 1
84.83
± 19.142
Cohort 2
88.73
± 7.382
Change from Baseline at the Treatment Completion Visit
Group
Value
95% CI
Cohort 1
1.03
± 1.087
Cohort 2
-0.66
± 2.815
Change from Baseline at the Post-Treatment Follow-Up Visit
Group
Value
95% CI
Cohort 1
-1.51
± 3.283
Cohort 2
1.93
± 5.435
Change in Low Luminance Questionnaire (LLQ) Driving Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up VisitsSecondary· 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
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 scor
Baseline Visit
Group
Value
95% CI
Cohort 1
86.00
± 20.433
Cohort 2
68.33
± 37.859
Treatment Completion Visit
Group
Value
95% CI
Cohort 1
87.00
± 17.889
Cohort 2
55.00
± 36.056
Post-Treatment Follow-Up Visit
Group
Value
95% CI
Cohort 1
84.00
± 22.192
Cohort 2
63.33
± 33.292
Change from Baseline at the Treatment Completion Visit
Group
Value
95% CI
Cohort 1
1.00
± 8.944
Cohort 2
-13.33
± 5.774
Change from Baseline at the Post-Treatment Follow-Up Visit
Group
Value
95% CI
Cohort 1
-2.00
± 4.472
Cohort 2
-5.00
± 5.000
Change in Low Luminance Questionnaire (LLQ) Extreme Lighting Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up VisitsSecondary· 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
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) subs
Baseline Visit
Group
Value
95% CI
Cohort 1
81.25
± 18.880
Cohort 2
73.96
± 26.578
Treatment Completion Visit
Group
Value
95% CI
Cohort 1
84.38
± 20.492
Cohort 2
77.08
± 25.259
Post-Treatment Follow-Up Visit
Group
Value
95% CI
Cohort 1
78.75
± 20.420
Cohort 2
80.83
± 12.521
Change from Baseline at the Treatment Completion Visit
Group
Value
95% CI
Cohort 1
3.13
± 5.846
Cohort 2
3.13
± 5.413
Change from Baseline at the Post-Treatment Follow-Up Visit
Group
Value
95% CI
Cohort 1
-2.50
± 6.775
Cohort 2
6.88
± 26.612
Change in Low Luminance Questionnaire (LLQ) Mobility Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up VisitsSecondary· 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
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 sco
Baseline Visit
Group
Value
95% CI
Cohort 1
88.33
± 16.245
Cohort 2
96.53
± 3.182
Treatment Completion Visit
Group
Value
95% CI
Cohort 1
90.00
± 14.006
Cohort 2
97.22
± 2.406
Post-Treatment Follow-Up Visit
Group
Value
95% CI
Cohort 1
88.33
± 15.975
Cohort 2
97.22
± 2.406
Change from Baseline at the Treatment Completion Visit
Group
Value
95% CI
Cohort 1
1.67
± 2.282
Cohort 2
0.69
± 5.243
Change from Baseline at the Post-Treatment Follow-Up Visit
Group
Value
95% CI
Cohort 1
0.00
± 2.946
Cohort 2
0.69
± 5.243
Change in Low Luminance Questionnaire (LLQ) Emotional Distress Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up VisitsSecondary· 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
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) su
Baseline Visit
Group
Value
95% CI
Cohort 1
95.00
± 8.149
Cohort 2
97.22
± 4.811
Treatment Completion Visit
Group
Value
95% CI
Cohort 1
93.75
± 10.825
Cohort 2
95.14
± 4.337
Post-Treatment Follow-Up Visit
Group
Value
95% CI
Cohort 1
93.75
± 10.825
Cohort 2
97.92
± 3.608
Change from Baseline at the Treatment Completion Visit
Group
Value
95% CI
Cohort 1
-1.25
± 2.795
Cohort 2
-2.08
± 3.608
Change from Baseline at the Post-Treatment Follow-Up Visit
Group
Value
95% CI
Cohort 1
-1.25
± 2.795
Cohort 2
0.69
± 1.203
Change in Low Luminance Questionnaire (LLQ) General Dim Lighting Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up VisitsSecondary· 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
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)
Baseline Visit
Group
Value
95% CI
Cohort 1
82.50
± 26.087
Cohort 2
90.28
± 2.406
Treatment Completion Visit
Group
Value
95% CI
Cohort 1
84.17
± 24.008
Cohort 2
95.14
± 4.337
Post-Treatment Follow-Up Visit
Group
Value
95% CI
Cohort 1
82.50
± 25.069
Cohort 2
93.06
± 6.365
Change from Baseline at the Treatment Completion Visit
Group
Value
95% CI
Cohort 1
1.67
± 2.282
Cohort 2
4.86
± 4.337
Change from Baseline at the Post-Treatment Follow-Up Visit
Group
Value
95% CI
Cohort 1
0.00
± 2.946
Cohort 2
2.78
± 4.811
Change in Low Luminance Questionnaire (LLQ) Peripheral Vision Subscale Score From Baseline at the Treatment Completion and Post-Treatment Follow-Up VisitsSecondary· 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
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) sub
Baseline Visit
Group
Value
95% CI
Cohort 1
85.00
± 22.361
Cohort 2
94.44
± 9.623
Treatment Completion Visit
Group
Value
95% CI
Cohort 1
85.00
± 22.361
Cohort 2
97.22
± 4.811
Post-Treatment Follow-Up Visit
Group
Value
95% CI
Cohort 1
81.67
± 25.276
Cohort 2
100.00
± 0.000
Change from Baseline at the Treatment Completion Visit
Group
Value
95% CI
Cohort 1
0.00
± 0.000
Cohort 2
2.78
± 4.811
Change from Baseline at the Post-Treatment Follow-Up Visit
Group
Value
95% CI
Cohort 1
-3.33
± 7.454
Cohort 2
5.56
± 9.623
Adverse events — posted to ClinicalTrials.gov
Time frame: Participants enrolled are assessed for AEs starting at Baseline through study completion (Month 3 for Cohort 1 and Month 2 for Cohort 2)..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Eye Institute (NEI)
Last refreshed: 15 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03478865.